NCT01289600

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

2.2 years

First QC Date

January 27, 2011

Last Update Submit

June 9, 2015

Conditions

ARDS

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Transpulmonary pressure

    average of last 15 minutes of each study arm

  • Transdiaphragmatic pressure

    average of last 15 minutes of each study arm

  • Oxygenation index

    at the end of each study arm

  • Dead space ventilation

    average of last 15 minutes of each study arm

Study Arms (4)

Pressure support ventilation, ARDSnet

ACTIVE COMPARATOR

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

Pressure control ventilation, ARDSnet

ACTIVE COMPARATOR

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

Neurally adjusted ventilatory assist, ARDSnet

ACTIVE COMPARATOR

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

Neurally adjusted ventilatory assist, titrated

ACTIVE COMPARATOR

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

Device: Mechanical ventilation

Interventions

Mechanical ventilationDEVICE

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

Also known as: Maquet Servo-i
Neurally adjusted ventilatory assist, ARDSnetNeurally adjusted ventilatory assist, titratedPressure control ventilation, ARDSnetPressure support ventilation, ARDSnet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • intubated, mechanically ventilated patients
  • meeting criteria for ARDS
  • mean arterial blood pressure \> 65 mmHg (with or w/o vasopressors)

You may not qualify if:

  • pregnancy
  • increased intracranial pressure
  • contra-indication naso-gastric tube
  • diagnosed neuro-muscular disorder
  • recent (\<12 hours) use of muscle relaxants
  • open chest or- abdomen
  • very high inspiratory flow rate during supported ventilation
  • inability to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Nijmegen

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Leo Heunks, MD, PhD

    Radboud University Nijmegen Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 4, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

NL(1)