"NAVA-PAV" Study: a Cross-over Comparative Study of 2 Advanced Modes

December 2, 2014 updated by: University Hospital, Montpellier

Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study

Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between NAVA and PAV+.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twenty patients will be enrolled. They will be ventilated with PAV+ and NAVA for one day, each in a randomized crossover order. The oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern will be compared.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 3

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
      • Montpellier, France, 34000
        • Department of Anesthesiology & Critical Care, St Eloi University Hospital

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:

  • Estimated remaining duration of mechanical ventilation for more than two days
  • patient alert and calm
  • Surrogate decision maker's consent

Exclusion Criteria:

  • Clinical contraindication for the use of NAVA: contraindications for an EAdi catheter placement (e.g., esophageal varices, upper gastrointestinal bleeding, gastroesophageal surgery)
  • Clinical instability for any reason
  • Contraindications for continuing intensive care treatment
  • Patient under tutelage
  • Age < 18 years
  • Pregnancy
  • No French health insurance

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: NAVA ventilatory mode
Other: NAVA ventilatory mode
The two ventilatory modes will be studied during 24h in intubated patients in random order.
Other: PAV+ ventilatory mode
Other: PAV+ ventilatory mode
The two ventilatory modes will be studied during 24h in intubated patients in random order.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oxygenation in NAVA and in PAV+
Time Frame: after one day of ventilation in NAVA and in PAV+
after one day of ventilation in NAVA and in PAV+

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilatory comfort
Time Frame: Every 6 hours in the two ventilatory modes

Ventilatory comfort will be assessed by :

  • objective criteria expressed in time spent in each mode in the area called "comfort" (12 < Respiratory frequence < 28 c/min ; Current Volume > 300 mL and EtCO2 < 55 mmHg)
  • subjective criteria expressed by the self-assessment of the patient's comfort on a visual analogic scale.
Every 6 hours in the two ventilatory modes
Patient-ventilator asynchronies
Time Frame: During the 24h of mechanical ventilation in NAVA and in PAV+
The patient-ventilator asynchronies will be assessed by the asynchronie index (number of asynchronies / number of respiratory cycles). The number of asynchronies will be assessed by the investigator, on the records of the pression curves and the respirator outputs.
During the 24h of mechanical ventilation in NAVA and in PAV+
Ventilatory parameters
Time Frame: During the 24h of mechanical ventilation in NAVA and in PAV+
The aeration and pulmonary ventilation will be assessed by electrical impedance (PulmoVista®500, Drager, Suisse).
During the 24h of mechanical ventilation in NAVA and in PAV+
Sleep pattern
Time Frame: During 24h of mechanical ventilation in NAVA and in PAV+
During 24h of mechanical ventilation in NAVA and in PAV+

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

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

May 1, 2012

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 18, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 30, 2012

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 8916

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.

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