Back to resultsMechanical Ventilation and Respiratory Muscle Work of Breathing in Acute Respiratory Distress Syndrome (ARDS) Patients
Primary Purpose
ARDS
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mechanical ventilation
Sponsored by
About this trial
This is an interventional treatment trial for ARDS
Eligibility Criteria
Inclusion Criteria:
- intubated, mechanically ventilated patients
- meeting criteria for ARDS
- mean arterial blood pressure > 65 mmHg (with or w/o vasopressors)
Exclusion Criteria:
- pregnancy
- increased intracranial pressure
- contra-indication naso-gastric tube
- diagnosed neuro-muscular disorder
- recent (<12 hours) use of muscle relaxants
- exclusion from sedation interruption protocol as used in our institution
- open chest or- abdomen
- very high inspiratory flow rate during supported ventilation
- inability to obtain informed consent
Sites / Locations
- University Medical Center Nijmegen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Pressure support ventilation, ARDSnet
Pressure control ventilation, ARDSnet
Neurally adjusted ventilatory assist, ARDSnet
Neurally adjusted ventilatory assist, titrated
Arm Description
Mechanical ventilator is set to pressure support ventilation (6 ml/kg) for 30 min with positive end expiratory pressure (PEEP) set according to the "higher arm" of the ARDS network consensus.
Mechanical ventilator is set to pressure control ventilation (6 ml/kg) for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus.
Mechanical ventilator is set to NAVA for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus.
Mechanical ventilator is set to NAVA for 30 min with PEEP titrated using the diaphragm EMG signal.
Outcomes
Primary Outcome Measures
Pressure-time product of the diaphragm
The pressure-time product of the transdiaphragmatic pressure (Pdi) during inspiration is obtained for each breath by multiplying the corresponding mean inspiratory Pdi signal above the end-expiratory baseline by the inspiration time. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Patient - ventilator asynchrony index
Ventilator asynchrony is determined as the sum of the triggering and cycling-off delays per breath, expressed as a percentage of the total breath duration. The trigger delay is measured as the time difference between the onset of neural inspiration and the ventilator inspiratory flow, and the cycling delay as the time difference between the end of neural inspiration and the end of ventilator inspiratory flow. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Secondary Outcome Measures
Transpulmonary pressure
Transpulmonary pressure is determined as the difference between mouth pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Transdiaphragmatic pressure
Transdiaphragmatic pressure is determined as the difference between gastric pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Oxygenation index
Oxygenation index is determined as the ratio between arterial oxygen tension and fraction of inspired oxygen. Arterial oxygen tension is obtained at the end of each study arm.
Dead space ventilation
Dead space ventilation is determined each breath using the Bohr equation: (PaCO2-PeCO2/PaCO2)*Vt. Here Vt is tidal volume, PaCO2 is the partial pressure of carbon dioxide in the arterial blood, and PeCO2 is the end-tidal carbon dioxide tension in the expired air. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Full Information
NCT ID
NCT01289600
First Posted
January 27, 2011
Last Updated
June 9, 2015
Sponsor
University Medical Center Nijmegen
1. Study Identification
Unique Protocol Identification Number
NCT01289600
Brief Title
Mechanical Ventilation and Respiratory Muscle Work of Breathing in Acute Respiratory Distress Syndrome (ARDS) Patients
Official Title
The Role of Diaphragm Electromyography (EMG) Guided Mechanical Ventilation on Respiratory Physiology in Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Nijmegen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to demonstrate that mechanical ventilation guided by the diaphragm EMG signal (also know as neurally adjusted ventilatory assist [NAVA]) is superior compared to pressure support and pressure control ventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pressure support ventilation, ARDSnet
Arm Type
Active Comparator
Arm Description
Mechanical ventilator is set to pressure support ventilation (6 ml/kg) for 30 min with positive end expiratory pressure (PEEP) set according to the "higher arm" of the ARDS network consensus.
Arm Title
Pressure control ventilation, ARDSnet
Arm Type
Active Comparator
Arm Description
Mechanical ventilator is set to pressure control ventilation (6 ml/kg) for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus.
Arm Title
Neurally adjusted ventilatory assist, ARDSnet
Arm Type
Active Comparator
Arm Description
Mechanical ventilator is set to NAVA for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus.
Arm Title
Neurally adjusted ventilatory assist, titrated
Arm Type
Active Comparator
Arm Description
Mechanical ventilator is set to NAVA for 30 min with PEEP titrated using the diaphragm EMG signal.
Intervention Type
Device
Intervention Name(s)
Mechanical ventilation
Other Intervention Name(s)
Maquet Servo-i
Intervention Description
The mechanical ventilator is set to different ventilation modes as described in the individual arms.
Primary Outcome Measure Information:
Title
Pressure-time product of the diaphragm
Description
The pressure-time product of the transdiaphragmatic pressure (Pdi) during inspiration is obtained for each breath by multiplying the corresponding mean inspiratory Pdi signal above the end-expiratory baseline by the inspiration time. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Time Frame
average of last 15 minutes of each study arm
Title
Patient - ventilator asynchrony index
Description
Ventilator asynchrony is determined as the sum of the triggering and cycling-off delays per breath, expressed as a percentage of the total breath duration. The trigger delay is measured as the time difference between the onset of neural inspiration and the ventilator inspiratory flow, and the cycling delay as the time difference between the end of neural inspiration and the end of ventilator inspiratory flow. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Time Frame
average of last 15 minutes of each study arm
Secondary Outcome Measure Information:
Title
Transpulmonary pressure
Description
Transpulmonary pressure is determined as the difference between mouth pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Time Frame
average of last 15 minutes of each study arm
Title
Transdiaphragmatic pressure
Description
Transdiaphragmatic pressure is determined as the difference between gastric pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Time Frame
average of last 15 minutes of each study arm
Title
Oxygenation index
Description
Oxygenation index is determined as the ratio between arterial oxygen tension and fraction of inspired oxygen. Arterial oxygen tension is obtained at the end of each study arm.
Time Frame
at the end of each study arm
Title
Dead space ventilation
Description
Dead space ventilation is determined each breath using the Bohr equation: (PaCO2-PeCO2/PaCO2)*Vt. Here Vt is tidal volume, PaCO2 is the partial pressure of carbon dioxide in the arterial blood, and PeCO2 is the end-tidal carbon dioxide tension in the expired air. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Time Frame
average of last 15 minutes of each study arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
intubated, mechanically ventilated patients
meeting criteria for ARDS
mean arterial blood pressure > 65 mmHg (with or w/o vasopressors)
Exclusion Criteria:
pregnancy
increased intracranial pressure
contra-indication naso-gastric tube
diagnosed neuro-muscular disorder
recent (<12 hours) use of muscle relaxants
exclusion from sedation interruption protocol as used in our institution
open chest or- abdomen
very high inspiratory flow rate during supported ventilation
inability to obtain informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo Heunks, MD, PhD
Organizational Affiliation
Radboud University Nijmegen Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Nijmegen
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
12. IPD Sharing Statement
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Mechanical Ventilation and Respiratory Muscle Work of Breathing in Acute Respiratory Distress Syndrome (ARDS) Patients
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