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

NCT ID: NCT01289600

Last Updated: 2015-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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ARDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Mechanical ventilation

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Mechanical ventilation

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Mechanical ventilation

Intervention Type DEVICE

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

Neurally adjusted ventilatory assist, titrated

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

Group Type ACTIVE_COMPARATOR

Mechanical ventilation

Intervention Type DEVICE

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

Interventions

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Mechanical ventilation

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

Intervention Type DEVICE

Other Intervention Names

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Maquet Servo-i

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Nijmegen

OTHER

Sponsor Role lead

Responsible Party

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Leo Heunks

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leo Heunks, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medical Center

Locations

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University Medical Center Nijmegen

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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ARDS1

Identifier Type: -

Identifier Source: org_study_id

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