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

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

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.

Study Overview

• Status: Completed
• Conditions: ARDS
• Intervention / Treatment: Device: Mechanical ventilation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • University Medical Center Nijmegen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: Maquet Servo-i

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Medical Center Nijmegen
• Investigators: Principal Investigator: Leo Heunks, MD, PhD, Radboud University Nijmegen Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: February 2, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Estimate): June 10, 2015
• Last Update Submitted That Met QC Criteria: June 9, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: ARDS1