Mechanical Ventilation and Respiratory Muscle Work of Breathing in Acute Respiratory Distress Syndrome (ARDS) Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University Medical Center Nijmegen.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Medical Center Nijmegen
Information provided by:
University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01289600
First received: January 27, 2011
Last updated: February 2, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Respiratory Distress Syndrome |
Device: Mechanical ventilation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Role of Diaphragm Electromyography (EMG) Guided Mechanical Ventilation on Respiratory Physiology in Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS) |
Further study details as provided by University Medical Center Nijmegen:
Primary Outcome Measures:
- Pressure-time product of the diaphragm [ Time Frame: average of last 15 minutes of each study arm ] [ Designated as safety issue: No ]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 [ Time Frame: average of last 15 minutes of each study arm ] [ Designated as safety issue: No ]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 [ Time Frame: average of last 15 minutes of each study arm ] [ Designated as safety issue: No ]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 [ Time Frame: average of last 15 minutes of each study arm ] [ Designated as safety issue: No ]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 [ Time Frame: at the end of each study arm ] [ Designated as safety issue: No ]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 [ Time Frame: average of last 15 minutes of each study arm ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 12 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pressure support ventilation, ARDSnet
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.
|
Device: Mechanical ventilation
The mechanical ventilator is set to different ventilation modes as described in the individual arms.
Other Name: Maquet Servo-i
|
|
Active Comparator: Pressure control ventilation, ARDSnet
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.
|
Device: Mechanical ventilation
The mechanical ventilator is set to different ventilation modes as described in the individual arms.
Other Name: Maquet Servo-i
|
|
Active Comparator: Neurally adjusted ventilatory assist, ARDSnet
Mechanical ventilator is set to NAVA for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus.
|
Device: Mechanical ventilation
The mechanical ventilator is set to different ventilation modes as described in the individual arms.
Other Name: Maquet Servo-i
|
|
Active Comparator: Neurally adjusted ventilatory assist, titrated
Mechanical ventilator is set to NAVA for 30 min with PEEP titrated using the diaphragm EMG signal.
|
Device: Mechanical ventilation
The mechanical ventilator is set to different ventilation modes as described in the individual arms.
Other Name: Maquet Servo-i
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289600
Contacts
| Contact: Leo Heunks, MD, PhD | +31 24 3617273 | L.Heunks@ic.umcn.nl |
Locations
| Netherlands | |
| University Medical Center Nijmegen | Recruiting |
| Nijmegen, Gelderland, Netherlands, 6525 GA | |
| Contact: Leo Heunks, MD, PhD +31 24 3617273 L.Heunks@ic.umcn.nl | |
Sponsors and Collaborators
University Medical Center Nijmegen
Investigators
| Principal Investigator: | Leo Heunks, MD, PhD | Radboud University Nijmegen Medical Center |
More Information
No publications provided
| Responsible Party: | Leo Heunks, University Medical Center Nijmegen |
| ClinicalTrials.gov Identifier: | NCT01289600 History of Changes |
| Other Study ID Numbers: | ARDS1 |
| Study First Received: | January 27, 2011 |
| Last Updated: | February 2, 2011 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |
ClinicalTrials.gov processed this record on June 18, 2013