Clinical Guide
48 Pages
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Different Thinking for Better Healthcare.®
NKV-550 Ventilator Series Evidence-Based Clinical Guide Version 1 © 2019 All Rights Reserved
Table of Contents Introduction
1
Recruitability Assessment (RA) Application
2
What is a Recruitability Assessment Application?
3
Why is it important to a clinician and for patient outcome?
4
How to use the Recruitability Assessment Application
5
Ventilator Models
5
Applicable Therapy Types and Patient Sizes
5
Operation
5
Additional Notes
8
References
8
Recruitment Maneuver (RM) Application
9
What is a Recruitment Maneuver Application?
10
Why is it important to a clinician and for patient outcome?
11
How to use the Recruitment Maneuver Application
11
Ventilator Models
11
Applicable Therapy Types and Patient Sizes
12
Operation
12
Additional Notes
14
References
14
PEEP Titration Application
15
What is the PEEP Titration Application?
16
Why is it important to a clinician and for patient outcome?
17
How to use the PEEP Titration Application
17
Ventilator Models
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17
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Applicable Therapy Types and Patient Sizes
17
Operation
18
Additional Notes
19
References
20
Transpulmonary Pressure Monitoring (TPP) Application
21
What is the Transpulmonary Pressure Application?
22
Why is it important to a clinician and for patient outcome?
23
How to use the Transpulmonary Pressure Monitoring Application
23
Ventilator Models
23
Applicable Therapy Types and Patient Sizes
23
Operation
24
References
25
Protective Control
26
What is Protective Control?
27
Why should a clinician use Protective Control?
27
How to use Protective Control
29
Parts Needed
29
Operation
29
References
30
Airway Suction Applications
31
What are Airway Suction Applications?
32
Why is this important to a clinician and for patient outcome?
32
How to use the Airway Suction Applications
33
Ventilator Models
33
Applicable Therapy Types and Patient Sizes
33
Operation of the Inline Airway Suction App
33
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Operation of the Open Airway Suction App
35
Technical Data
37
Additional Notes
38
References
38
High-Flow Nasal Cannula and Oxygen Therapy
39
What is High-Flow Nasal Cannula and Oxygen Therapy?
40
Why is this important to a clinician and for patient outcome?
41
Ventilator Models
41
Applicable Patient Sizes
41
Operation of Oxygen Therapy
42
Technical Data
42
References
43
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1
Introduction This evidence-based clinical guide is designed to assist you to learn the various applications that support lung protective strategies, improve workflow, and to help protect clinicians from biological and radiological hazards. It is also designed as a reference tool when you need a refresher for infrequently performed procedures. The procedures in this guide are for the NKV-550 Ventilator Series, based on use in adult, pediatric, and neonatal environments. The evidence-based clinical guide is an adjunct to the operators manual and does not replace it. Please refer to that manual for critical, technical, and other specific information and for additional information as directed in this guide.
For technical or clinical product assistance, a toll-free customer support service is provided at 1-800-325-0283.
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2
Recruitability Assessment Application The response to increased PEEP varies widely in patients with ARDS: some accrue large reductions in collapsed lung, while others exhibit minimal lung recruitment. A secondary analysis of these trials showed that a favorable physiological response to PEEP predicates lower mortality.
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Goligher Lancet 20161
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3
What is the Recruitability Assessment Application? The recruitability assessment app is a software-based application (app) offered by the Nihon Kohden NKV-550 ventilator that allows a clinician to assess whether a patient will benefit from performing a lung recruitment maneuver. By setting a few parameters in this app, the clinician can permit the ventilator to execute a procedure where the ventilator will ventilate the patient while increasing the PEEP step by step. After the clinician-set maximum allowed airway pressure is reached, the ventilator will continue to ventilate the patient while decreasing the PEEP step by step, in a symmetrical way to the PEEP-increasing phase. At the end of the procedure, the ventilator will display the PEEP value with the highest compliance improvement and will calculate the recruitable volume. Recruitable volume informs the clinician how much lung volume can be recruited if this PEEP level is used after the lungs are recruited.
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4
Why is this important to a clinician and for patient outcome? The Open Lung Approach has been used by many clinicians for patients receiving mechanical ventilation. This includes recruiting the lungs and determining the PEEP level necessary to maintain the lungs open by a decremental PEEP trial (i.e., PEEP titration).2 Kacmarek et al demonstrated, in a prospective, multicenter, pilot, randomized clinical trial, that in those patients diagnosed with acute respiratory distress syndrome (ARDS), the Open Lung Approach improved oxygenation and decreased driving pressure.2 In a study by Cinnella et al, these same two physiological effects were improved in those patients presenting with mild, diffuse ARDS.3 Leme et al compared moderate lung recruitment against intensive lung recruitment in postoperative ICU patients and found the use of intensive lung recruitment resulted in a shorter ICU stay, a shorter hospital stay, and less severe pulmonary complications compared to using moderate lung recruitment.4 Ventilated patients may have a varying response to lung recruitment. In some patients, lung recruitment may not be beneficial, because the patient has healthy lungs or lung injuries that would not benefit from lung recruitment.1 As elaborated by Goligher EC et al, the extent to which collapsed lung units may be reopened (recruited) varies substantially between patients.1 The recruitability assessment app provides a tool for the clinician to assess how a patient responds to recruitment. Moreover, by using the recruitment assessment, the clinician may be able to avoid performing a complete recruitment maneuver and PEEP titration procedure on those patients who would not benefit from lung recruitment.
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5
How to use the Recruitability Assessment Application Chapter 3: System Overview
Button
Ventilator Models
5
NKV-550-U NKV-550-S
Name
Button
Name
Manual breath
Non-invasive ventilation (spontaneous breath)
O2 therapy
Expansion button
Chapter 3: System Overview Invasive ventilation
Waveform freeze button (active
Button
Applicable Therapy Types and Patient Sizes
Name
Button
Name
Non-in Waveform freeze button(sponta
Invasive ventilation (controlled breath)
Manual breath
Invasive ventilation (assisted breath)
O2 therapy
Invasive ventilation (spontaneous breath)
Invasive ventilation
Wavefo Preventive maintenance neede Manual breath
Invasive ventilation Non-invasive ventilation(controlled breath)
Neonatal flow sensor calibratio O2 therapy Wavefo needed
Non-invasive ventilationInvasive ventilation (assisted breath) (controlled breath)
Close m Invasive ventilatio
Non-invasive ventilationInvasive ventilation (spontaneous breath) (assisted breath)
Invasive ventilatio Preven (controlled breath
Chapter 3: System Overview Expans Close menu
Button
• This app is applicable in all modes of invasive therapy
Name
Chapter 3: System Overview
Touchscreen Icons and Buttons • It is not applicable during non-invasive therapy
or O2 Therapy
Table 3-4: Touchscreen Icons and Buttons
Name ChapterButton 3: System Overview
Button
Name
• This appTouchscreen is applicable Icons and Buttonsfor patients with a body weight of ≥25 Kg Patient data entry: adult
Open airway suction
Table 3-4: Touchscreen Icons and Buttons
• The clinician cannot use this app if the input predicted body weight is less than 25 kg or if the patient size choice is neonate Button
Name
Button
Patient data entry: pediatric
Patient data entry: adult
Patient data entry: neonate
Patient data entry: pediatric
Battery Status (general) Patient data entry: neonate
Operation
Alarm settings Battery Status (general)
Name
PEEP titration
Open airway suction
Non-invasive ventilation
Neona Invasive ventilatio needed (assisted breath)
Non-invasive ventilation (controlled breath)
Invasive ventilatio (spontaneous brea
Non-invasive ventilation (assisted breath)
Non-invasive vent
34 | NKV-550 Series Ventilator System
Auxiliary pressure
PEEP titration
Transpulmonary pressure Auxiliary pressure
Non-invasive vent (controlled breath
Spontaneous breathing trial Transpulmonary pressure 34 | NKV-550 Series Ventilator System
Alarm limit set to off
Chapter 3: System Overview
Alarm settings
Spontaneous breathing trial
Button
Alarm audio paused (active)
Alarm limit set to off
Name
Alarm audio paused (active)
NIF/PiMax
Data retrieval
Recruitment maneuver
Trends
1. Click the recruitability assessment app icon Alarm audio not paused (inactive)
Button
Chapter 3: System Ove
Name
Recruitment maneuver
Volumetric capnogram
P0.1
Button
Alarm audio not paused (inactive)
Non-invasive vent (assisted breath)
Volumetric capnogram
The clinician must ensure that the patient’s hemodynamic and respiratory conditions are stable for this procedure.2 It is important to note that the patient needs to be apneic prior to and during the entire recruitment assessment. Help
Name
Button 34 | NKV-550 Name Series Ventilator System
P0.1 Low flow PV maneuver
Elevated O2
Help
Low flow PV maneuver Recruitability assessment
Camera
Elevated O2
Camera
Data retrieval
32 | NKV-550 Series Ventilator System
Standby
Recruitability assessment
Video
Sensors
Standby
Inspiratory HoldVideo
• If this icon is greyed out, it means either the patient is not receiving invasive ventilation therapy or 60 seconds have not passed since this app or the recruitment maneuver app was last performed. NIF/PiMax
Trends
32 | NKV-550 Series Ventilator System
Sensor disabled Sensors
Expiratory hold Inspiratory Hold
2. After reading the warning message, press the right arrow button to move to the setting page. Custom setting Sensor disabled
Expiratory hold Screen brightness
Custom setting Inline airway suction
Logs
Screen brightness
Inline airway suction
Screen lock
Logs
Home
Screen lock NKV-550 Series Ventilator System | 33
• The predicted body weight of the patient must be ≥25 Kg in order to proceed. Home
NKV-550 Series Ventilator Syste
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6 3. Set the following control settings for the recruitability assessment: Setting Default
Setting Range
s PC: 15 cmH2O
10 to 20 cmH2O
I:E ratio: 1:1
4:1 to 1:299
RR: 20 bpm
10 - 25 bpm
FiO2: 21%
21 to 100%
Max. pressure allowed: 30 cmH2O
30 - 55 cmH2O
PEEP change each PEEP step: 5 cmH2O
2 - 5 cmH2O
Duration for each PEEP step: 20 sec
20 to 180 sec
The graph will show the preview of the procedure based on the control settings. Chapter 3: System Overview
Button
Name
4. The clinician can press the “Help” button graph to obtain help information.
Button
Name
P0.1
below the preview
Low flow PV maneuver
Elevated O2
Help
5. Press the “Start” button to start the procedure. During the procedure, the ventilator will ventilate the patient using the identified control settings in this app, temporarily overriding the general ventilation settings. Recruitability assessment
Camera
Standby
Video
Sensors
Inspiratory Hold
• If the “Start” button is greyed out, it means that the “Maximum pressure allowed” setting is ≥ the “High Paw alarm” setting. •
Sensor disabled
Expiratory hold
Custom setting
Screen brightness
To resolve this condition, the clinician will need to adjust either the “Maximum pressure allowed” setting or the “High Paw alarm” setting or both settings to make sure the “Maximum pressure allowed” is lower than the “High Paw alarm” setting.
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Inline airway suction
Logs
Home
Screen lock
NKV-550 Series Ventilator System | 33
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7 6. It is recommended that the clinician to stay at the bedside to observe the patient’s condition carefully. • During the procedure, patient triggering will be disabled. If a patient effort is detected, a “Patient Effort Detected” alarm message will be displayed. • A “Hold Step” button allows the clinician to extend the time for the current PEEP step. Pressing “Resume Step” will continue the recruitability assessment as programmed. • If the procedure needs to be stopped, the clinician will press the “End” button. 7. When the procedure is completed, the ventilator will resume normal ventilation and display the following results:
• PEEP: the measured PEEP at highest compliance.
•
Recruitable volume: the change in tidal volume between the tidal volume at highest compliance during the decremental portion of the procedure and the tidal volume at the same PEEP level during the incremental portion of the procedure.
•
Gain in compliance: the change in compliance between the highest compliance during the decremental portion of the procedure and the compliance at the same PEEP level during the incremental portion of the procedure.
8. At the end of the procedure, a vertical cursor will be displayed with the measured values for the current cursor position. The clinician can move the cursor to view measured results throughout the procedure. The parameter of the Y axis of the second graph can be changed so the clinician can study the relationship between PEEP and various other parameters (e.g., compliance, SpO2, EtCO2).
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8
Additional Notes You cannot operate this app within 60 seconds after the completion of the last performed recruitability assessment or recruitment maneuver. The patient should be assessed for adverse side effects before and after the recruitment assessment.6 Moreover, follow the warnings and precautions in the device operators manual to ensure the safety of the procedure operation.5
References 1
Goligher EC et al. Clinical challenges in mechanical ventilation. Lancet. 2016; 387:1856-1866.
2
Kacmarek RM et al. Open lung approach for the acute respiratory distress syndrome: A pilot, randomized controlled trial. Critical Care Medicine. 2016; 44:32-42.
3
Cinnella, G et al. Physiological effects of the open lung approach in patients with early, mild, diffuse acute respiratory distress syndrome: An electrical impedance tomography study. Anesthesiology. 2015; 123:1113-21.
4
Leme AC et al. Effect of intensive vs moderate alveolar recruitment strategies added to lung-protective ventilation on postoperative pulmonary complications: A randomized clinical trial. JAMA. 2017; 317:1422-1432.
5
NKV-550 Ventilator Series Operators Manual. Nihon Kohden OrangeMed, Inc. 2019/02 MAN5501-US Rev. A.
6
Hess, D. Recruitment maneuvers and peep titration. Am J Respir Crit Care Med. 2015; 60 (11): 1688-1704.
Disclaimer: This evidence-based clinical guide does not replace the device’s operators manual. For safely operating the device, please always read the device’s operators manual including its cautions and warnings.
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9
Recruitment Maneuver Application In patients with hypoxemia after cardiac surgery, the use of intensive alveolar recruitment resulted in less severe pulmonary complications and shorter ICU stays and shorter hospital stays.
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Leme JAMA1
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10
What is a Recruitment Maneuver Application? The recruitment maneuver app is a software-based application (app) offered by the Nihon Kohden NKV-550 ventilator that allows a clinician to recruit the collapsed lungs or lung regions of a patient. By setting a few parameters in this app, the clinician can permit the ventilator to execute a recruitment maneuver. During the maneuver, the ventilator will ventilate the patient while increasing the PEEP step by step, eventually elevating the airway pressure until collapsed lung units are recruited (i.e., re-opened). At the end of the procedure, the clinician can select to resume normal ventilation or transition to a PEEP Titration procedure.
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11
Why is this important to a clinician and for patient outcome? The Open Lung Approach has been used by many clinicians for patients receiving mechanical ventilation. This includes recruiting the lungs and determining a PEEP level necessary to maintain the lungs open by a decremental PEEP trial (i.e., PEEP titration).2 Kacmarek et al demonstrated, in a prospective, multicenter, pilot, randomized clinical trial, in those patient’s diagnosed with acute respiratory distress syndrome (ARDS), the Open Lung Approach improved oxygenation and decreased driving pressure.2 In a study by Cinnella et al, these same two physiological effects were improved in those patient’s presenting with mild, diffuse ARDS.3 Moreover, Leme et al compared moderate lung recruitment against intensive lung recruitment in postoperative ICU patients and found the use of intensive lung recruitment resulted in a shorter ICU stay, a shorter hospital stay, and less severe pulmonary complications compared to using moderate lung recruitment.1 Even though lung recruitment has been demonstrated as beneficial for many patients receiving mechanical ventilation, this procedure is not often practiced. According to an international survey of 50 countries in 2016, only 1 in every 5 ventilated patients with ARDS had a recruitment maneuver performed.4 The under-utilization of lung recruitment maneuvers may be due to the lack of a convenient tool for a clinician to perform this procedure. Therefore, a recruitment maneuver app is available on the NKV-550 ventilator to serve this clinical need.
How to use the Recruitment Maneuver Application Ventilator Models5 NKV-550-U NKV-550-S
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Invasive ventilation
Waveform freeze button (active)
Button
Name
Invasive ventilation (controlled breath)
Applicable Therapy Types and Patient Sizes
Button
Invasive ventilation (spontaneous breath)
This app is applicable in all modes of invasive therapy
12
Expansion button
Name
Button
Invasive ventilation Preventive maintenance needed Manual breath
. It is not
Invasive ventilation Neonatal flow sensor calibration
Waveform freeze button Expan
(controlled Icons breath)O therapy Touchscreen and Buttons needed
Non-invasive ventilation
.
2
Table 3-4: Touchscreen Icons and Buttons Button Invasive Name ventilation
Non-invasive ventilation (controlled breath)
Chapter 3: System Overview
Button
Close menu
(assisted breath) Invasive ventilation
Patient data entry: adult
Wavef
This app is applicable for patients with a body weight of ≥25 Kg. Therefore,
Open airw
Table 3-4: Touchscreen Icons and Button
Table 3-4: Touchscreen Icons and Buttons Name
Name
Touchscreen Icons and Bu
Touchscreen Icons and Buttons Button
Name
Waveform freeze button Non-in (spont
Chapter 3: System Overview
or O2 Therapy
Chapter 3: System Overview
Name
Non-invasive ventilation (spontaneous breath)
Chapter 3: System Overview O2 therapy Close menu
Invasive ventilation (assisted breath)
applicable during non-invasive therapy
Button
Manual breath Waveform freeze button
Invasive ventilation Invasive ventilation Button (spontaneous breath) (controlled breath)
Non-invasive ventilation Button Name (assisted breath)
Patient data entry: pediatric
Preventive maintenance Name Wavef
the clinician cannot use this app if the input predicted body weight
PEEP titra Patient data entry: adu
is less than 25 kg, or if the patient size choice is neonate
Auxiliary Patient data entry: ped
Patient data entry: adult
Open airway suction
Neonatal flow sensor ca needed Close
Non-invasive ventilation Invasive ventilation (assisted breath)
Operation
.
| NKV-550 Series Ventilator System Patient data34entry: pediatric
PEEP titration
Patient data entry: neonate
Auxiliary pressure
Battery Status (general)
Transpulmonary pressure
Patient data entry: neonate
Non-invasive ventilation Invasive ventilation (controlled breath) (spontaneous breath)
Preven
Battery Status (general) Non-invasive ventilation (assisted breath) Non-invasive ventilation
Transpulm Patient data entry:Neona neo
Alarm settings Non-invasive ventilation
Spontane Battery Status (general
neede
The clinician must ensure the patient’s hemodynamic and respiratory conditions are stable for this procedure.1 It is important to note; the patient needs to be apneic prior to and during the entire recruitment maneuver. (controlled breath)
34 | NKV-550 Series Ventilator System Spontaneous breathing trial
Alarm settings
Non-invasive Alarm limit set to off ventilation
Volumetr Alarm settings
Alarm audio paused (active)
Recruitme Alarm limit set to off
(assisted breath)
Alarm limit set to off
Volumetric capnogram
Alarm audio paused (active)
Recruitment maneuver
1. Click the recruitment maneuver app icon
.
34 | NKV-550 Series Ventilator System
Alarm audio not paused (inactive)
Alarm audio not paused (inactive)
Data retrieval
NIF/PiMax
Trends
Data retri Alarm audio paused (ac
• If this icon is greyed out, it means either the patient is not receiving invasive ventilation therapy or 60 seconds have not passed since this app or the recruitment assessment app was last performed. NIF/PiMax
Trends Alarm audio not pause
32 | NKV-550 Series Ventilator System
NIF/PiMax
32 | NKV-550 Series Ventilator System
2. After reading the warning message, press the right arrow button to move to the setting page.
32 | NKV-550 Series Ventilator System
• The predicted body weight of the patient must be ≥ 25 Kg in order to proceed. 3. Set the following control settings for the recruitment maneuver: Setting Default
Setting Range
s PC: 15 cmH2O
10 to 20 cmH2O
I:E ratio: 1:1
4:1 to 1:299
RR: 20 bpm
10 - 25 bpm
FiO2: 21% to 100%
21 to 100%
Max. pressure allowed: 30 cmH2O
30 - 55 cmH2O
PEEP change each PEEP step: 5 cmH2O
2 - 5 cmH2O
Duration for each PEEP step: 20 sec
20 to 180 sec
PEEP after end of procedure: 25 cmH2O
0 - 30 cmH2O
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13 The graph will show the preview of the procedure based on the control settings. Chapter 3: System Overview
Button
Name
The clinician can press the “Help” button obtain help information.
Button
Name
P0.1
below the preview graph to
Low flow PV maneuver
Elevated O2
Help
4. Press the “Start” button to start the procedure. During the procedure, the ventilator will ventilate the patient using the identified settings in this app, temporarily overriding the general ventilation settings. Recruitability assessment
Camera
Standby
Video
Sensors
Inspiratory Hold
5. If the “Start” button is greyed out, it means that the “Maximum pressure allowed” setting is ≥ the “High Paw alarm” setting. To resolve this condition, the clinician will need to adjust either the “Maximum pressure allowed” setting or the “High Paw alarm” setting or both settings to make sure the “Maximum pressure allowed” is lower than the “High Paw alarm” setting. Sensor disabled
Expiratory hold
Custom setting
Screen brightness
Inline airway suction
Logs
Home
Screen lock
It is recommended for the clinician to stay at the bedside to observe the patient’s condition carefully. NKV-550 Series Ventilator System | 33
6. During the procedure, patient triggering will be disabled. If a patient effort is detected, a “Patient Effort Detected” alarm message will be displayed. 7. A “Hold Step” button allows the clinician to extend the time for the current PEEP step. Pressing “Resume Step” will continue the recruitment maneuver as programmed. 8. If the procedure needs to be stopped, the clinician simply presses the “End” button. When the procedure is completed, the ventilator will continue to use the recruitment maneuver settings to ventilate the patient but will keep the PEEP at the “PEEP after the end of the procedure” level. The clinician can either a) press the “End” button to cancel this PEEP and resume normal ventilation or b) press the “Go to PEEP titration” button to perform PEEP titration. If no action is taken by the clinician within 5 minutes, the ventilator will cancel the current PEEP and resume the normal ventilation settings. At the end of the procedure, a vertical cursor will be displayed with the measured values for the current cursor position. The clinician can
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14 move the cursor to view measured results throughout the procedure. The parameter of the Y axis of the second graph can be changed so the clinician can study the relationship between PEEP and various other parameters (e.g., compliance, SpO2, EtCO2).
Additional Notes The patient should be assessed for adverse side effects before and after the recruitment maneuver.6 Moreover, follow the warnings and precautions in the device operators manual to ensure the safety of the procedure operation.
References 1
Leme AC et al. Effect of intensive vs moderate alveolar recruitment strategies added to lung-protective ventilation on postoperative pulmonary complications: A randomized clinical trial. JAMA. 2017; 317:1422-1432.
2
Kacmarek RM et al. Open lung approach for the acute respiratory distress syndrome: A pilot, randomized controlled trial. Critical Care Medicine. 2016; 44:32-42.
3
Cinnella, G et al. Physiological effects of the open lung approach in patients with early, mild, diffuse acute respiratory distress syndrome: An electrical impedance tomography study. Anesthesiology. 2015; 123:1113-21.
4
Bellani et al. Epidemiology, patterns of care, and mortality for patients with acute respiratory distress syndrome in intensive care units in 50 countries. JAMA. 2016; 315:788-800.
5
NKV-550 Series Ventilator Operators Manual. Nihon Kohden OrangeMed, Inc. 2019/02 MAN5501-US Rev. A.
6
Hess, D. Recruitment maneuvers and peep titration. Am J Respir Crit Care Med. 2015; 60 (11): 1688-1704.
Disclaimer: This evidence-based clinical guide does not replace the device’s operators manual. For safely operating the device, please always read the device’s operators manual including its cautions and warnings.
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15
PEEP Titration Using PEEP titration to target positive transpulmonary pressure improved elastance and driving pressure, which could be associated with improved 28-day mortality. Kassis et al. Intensive Care Medicine 20161
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16
What is the PEEP Titration Application? The PEEP titration app is a software-based application (app) offered by the Nihon Kohden NKV-550 ventilator allowing a clinician to titrate the PEEP setting for their patients. By setting a few parameters in this app, the clinician can allow the ventilator to execute a PEEP titration procedure. During the procedure, the ventilator will ventilate the patient with a “Start PEEP” the clinician sets to be high enough for the lungs to be recruited (i.e., opened). The ventilator will then decrease the PEEP level step-by-step, eventually to a level where the lungs start to de-recruit (i.e., collapse). During this procedure, the ventilator will calculate the lung compliance at each PEEP level. When the procedure is completed, the ventilator will show which PEEP level achieved the highest lung compliance. At the end of the procedure, the clinician can select to resume normal ventilation or perform a recruitment maneuver.
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