Mechanical Ventilation and Respiratory Muscle Work of Breathing in Acute Respiratory Distress Syndrome (ARDS) Patients

ARDS Clinical Trial

Official title:

The Role of Diaphragm Electromyography (EMG) Guided Mechanical Ventilation on Respiratory Physiology in Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289600
• Other study ID #: ARDS1
• Status: Completed
• Phase: N/A
• First received: January 27, 2011
• Last updated: June 9, 2015
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: June 2015
• Source: University Medical Center Nijmegen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Mechanical ventilation
The mechanical ventilator is set to different ventilation modes as described in the individual arms.

Locations

Country	Name	City	State
Netherlands	University Medical Center Nijmegen	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Nijmegen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	average of last 15 minutes of each study arm	No
Primary	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.	average of last 15 minutes of each study arm	No
Secondary	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.	average of last 15 minutes of each study arm	No
Secondary	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.	average of last 15 minutes of each study arm	No
Secondary	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.	at the end of each study arm	No
Secondary	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.	average of last 15 minutes of each study arm	No