NCT02056093

Brief Summary

In spontaneously breathing mechanically ventilated patients, the adequacy between the patient's demand and the level of respiratory support delivered by the ventilator is a major clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist ventilation (PAV) have been developed to adapt the level of assistance to the patient's demand. These two modes have been compared to pressure support ventilation (PSV) but have not been compared to each other.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
Last Updated

February 5, 2014

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

December 18, 2013

Last Update Submit

February 4, 2014

Conditions

Acute Respiratory Failure

Keywords

NAVA - PAV- Breathing Variability - Asynchrony

Outcome Measures

Primary Outcomes (1)

  • Breathing pattern variability

    The coefficient of variation (standard deviation divided by the mean) of the tidal volume (expressed in %)

    February 2014

Secondary Outcomes (1)

  • Patient-ventilator asynchrony

    February, 2014

Other Outcomes (1)

  • Electrical diaphragm activity Gas exchange

    February 2014

Study Arms (1)

Intubated patients

EXPERIMENTAL

Intubated patients: The three modes (PSV, PAV, NAVA) will be applied in random order to each mechanically ventilated patient included in the study.

Device: PSV modeDevice: PAV modeDevice: NAVA

Interventions

PSV modeDEVICE

Application of PSV in all patients

Intubated patients
PAV modeDEVICE

Application of PAV mode in all patients

Intubated patients
NAVADEVICE
Intubated patients

Eligibility Criteria

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

You may qualify if:

  • Intubated patients.
  • Mechanical ventilation for a respiratory reason.
  • Expected duration of Mechanical ventilation \> 48 hrs.
  • Spontaneous breathing.
  • Sedations stopped for more than 24 hours.

You may not qualify if:

  • \- Main contra indications to NAVA: gastro-oesophageal surgery in the previous 12 months, oesophageal obstruction, gastro-esophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma or surgery, neuromuscular diseases, individuals with known or suspected phrenic nerve dysfunction.
  • Main contra indications to PAV: airway leak, body weight \<25 kg, neuromuscular diseases.
  • Hemodynamic instability defined as the current administration of vasopressors or inotropic drugs.
  • Severe hypoxemia defined as PaO2/FiO2 ratio \<200.
  • Decision to withhold life-sustaining treatment.
  • Pregnant women.
  • Minors \< 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere

Paris, Île-de-France Region, 75013, France

RECRUITING

Related Publications (1)

  • Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.

    PMID: 25879592DERIVED

Study Officials

  • Matthieu SCHMIDT, MD

    Association pour le Développement et l'Organisation de la Recherche en Pneumologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 18, 2013

First Posted

February 5, 2014

Study Start

September 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 5, 2014

Record last verified: 2014-02

Locations

FR(1)