Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist (PAVANAVA)

February 4, 2014 updated by: Matthieu SCHMIDT, Pierre and Marie Curie University

Breathing Pattern Variability, Respiratory Discomfort and Work of Breathing in Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75013
        • Recruiting
        • Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere
        • Contact:
        • Principal Investigator:
          • Matthieu Schmidt, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • - 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intubated patients
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 mode
Application of PSV in all patients
Device: PAV mode
Application of PAV mode in all patients
Device: NAVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breathing pattern variability
Time Frame: February 2014
The coefficient of variation (standard deviation divided by the mean) of the tidal volume (expressed in %)
February 2014

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-ventilator asynchrony
Time Frame: February, 2014
Prevalence of ineffective efforts and double triggering (expressed as a number of events per minute)
February, 2014

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrical diaphragm activity Gas exchange
Time Frame: February 2014
measured by the NAVA probe
February 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre and Marie Curie University

Investigators

  • Principal Investigator: Matthieu SCHMIDT, MD, Association pour le Développement et l'Organisation de la Recherche en Pneumologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

February 4, 2014

First Posted (Estimate)

February 5, 2014

Study Record Updates

Last Update Posted (Estimate)

February 5, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADOREP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Respiratory Failure

Clinical Trials on PSV mode

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe