Comparison of Humidification Devices During Non Invasive Ventilation, in Acute Respiratory Failure

October 25, 2011 updated by: Assistance Publique - Hôpitaux de Paris

Randomized RCT Comparing HH and HME During NIV in Acute Respiratory Failure

Comparison of humidification devices during non invasive ventilation, in acute respiratory failure.

The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comparison with HH.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Comparison of humidification devices during non invasive ventilation, in acute respiratory failure.

The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comlparison with HH Several physiological previously performed showed that 1) with HME, because of its working principles, humidification was reduced because of leaks 2) work of breathing was increased with HME because of dead space and 3) alveolar ventilation was reduced with HME because of additional technical dead space.

For these reasons, the hypothesis was an improvement of NIV tolerance, of efficiency to clear te CO2 with HH in comparison with HME and finally to reduce the intubation rate with HH.

The patients were included when requiring NIV (see inclusion and exclusion criteria) and randomisation was performed with stratification according to presence or absence of respiratory acidosis.

The number of patients to include was baszd on the hypothesis that intubation rate would be reduced from 40 with HME to 25% with HME. A total of 250 patients was required with alpha risk of 0,05 and beta risk of 0,2 (power 80%). Intubation criteria were predefined according to the litterature. The expected duration was 18 months. The official support was institutional (DRRC of AP-HP). HH were furnished free of charge, as well as HME. Masks used were the same in both groups.

Study Type

Interventional

Enrollment

250

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

  • Canada
      • Quebec, Canada
        • Département d'Anesthésie - Hôpital de l'Enfant Jésus
  • France
      • Argenteuil, France
        • Hôpital Victor Dupouy, Argenteuil
      • Brest, France
        • CHU de la Cavale Blanche
      • Clichy, France
        • Réanimation du Service de Pneumologie - Centre Hospitalier Beaujon
      • Colombes, France
        • Réanimation Médicale - Hôpital Louis Mourier
      • Montpellier, France
        • Département d'Anesthésie-Réanimation "B" - CHU Saint Eloi
      • Paris, France
        • Hôpital Georges Pompidou HEGP
      • Paris, France
        • Réanimation du Service Pneumologie - Hôtel Dieu
      • Paris, France
        • Réanimation pneumologique, Hôpital Pitié Salpétrière
      • Paris, France
        • Réanimation Pneumologique- CHU Tenon
      • Poissy, France
        • Réanimation Médicale - Centre Hospitalier Intercommunal de Poissy
      • Rouen, France
        • Réanimation Médicale, Hôpital Charles Nicolle
  • Italy
      • Roma, Italy
        • Istituto di anestesiologia e Rianimazione - Università Cattolica Policlinico A. Gemelli
  • Tunisia
      • Monastir, Tunisia
        • Réanimation Polyvalente - CHU Fatima Bourguiba

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

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 85 years
  • Exacerbation of dyspnea lasting less than two weeks

TWO OR THREE following criteria :

  • Respiratory rate higher or equal to 25 b/min
  • SaO2 lower or equal to 90% (breathing room air or oxygen)
  • Arterial pH < 7.35

Exclusion Criteria:

  • immediate need for intubation
  • cardiac arrest or RR< 10 breaths/min.
  • systemic hypotension (SAP < 80 mmHg ) with no response to 500 ml of macromolecules
  • coma defined by GCS < 8.
  • high probability of surgical procedure
  • major facial deformity
  • pneumothorax
  • bad short-term prognosis
  • refusal of intubation by the patient or do not intubated order.

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intubation rate
Time Frame: during the study
during the study

Secondary Outcome Measures

Outcome Measure
Time Frame
-Physiological outcome at 1,3 and 6 hours (arterial blood gases, respiratory rate)
Time Frame: during the study
during the study
-Intolerance of NIV
Time Frame: during the study
during the study
- Frequency of VAP
Time Frame: during the study
during the study
- Duration of total MV duration
Time Frame: during the study
during the study
- ICU LOS
Time Frame: during the study
during the study
- Hospital LOS
Time Frame: during the study
during the study
- Mortality (ICU and hospital)
Time Frame: during the study
during the study

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Chair: Nicolas Best, DRRC hopitaux de Paris

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

December 1, 2001

Study Completion

April 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

October 26, 2011

Last Update Submitted That Met QC Criteria

October 25, 2011

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC 2001 (Other Grant/Funding Number: Ministry of Health)

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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