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

University Medical Center Nijmegen12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ARDS

Interventions

Mechanical ventilationDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Nijmegen

Nijmegen, Gelderland, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: average of last 15 minutes of each study arm

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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