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

University Medical Center Nijmegen

Status

Completed

Conditions

ARDS

Treatments

Device: Mechanical ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT01289600

ARDS1

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 4 patient groups

Pressure support ventilation, ARDSnet

Active Comparator group

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.

Treatment:

Device: Mechanical ventilation

Pressure control ventilation, ARDSnet

Active Comparator group

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.

Treatment:

Device: Mechanical ventilation

Neurally adjusted ventilatory assist, ARDSnet

Active Comparator group

Description:

Mechanical ventilator is set to NAVA for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus.

Treatment:

Device: Mechanical ventilation

Neurally adjusted ventilatory assist, titrated

Active Comparator group

Description:

Mechanical ventilator is set to NAVA for 30 min with PEEP titrated using the diaphragm EMG signal.