Gases Humidification During Noninvasive Ventilation : Heat and Moisture Exchanger or Heated Humidifier ?

May 7, 2013 updated by: University Hospital, Bordeaux

Prospective Study of the Influence of the Humidification Mode on Ventilation Parameters and Arterial Blood Gases in Non Invasive Ventilation

To humidify gases during non invasive ventilation, both to heated humidifier (HH) and heat and moisture exchanger (HME) are routinely used. Patients receiving non invasive ventilation for acute respiratory failure were randomized to HME or HH. The purpose of this study was to evaluate respiratory parameters and arterial blood gases (ABG) of patients during NIV with small dead space HME compared to HH.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Objective: Few data are reported in the field of noninvasive ventilation (NIV) regarding humidification devices. It was previously suggested that standard heat and moisture exchangers (HME) had adverse gasometrical and clinical outcomes in acute respiratory failure (ARF) of chronic respiratory failure patients (CRF). This study was performed to evaluate respiratory parameters and arterial blood gases (ABG) of patients during NIV with small dead space HME compared to heated humidifier (HH).

Design: Prospective randomized cross-over study. Setting: A 16-bed medical intensive care unit (ICU) and a 14-bed medico surgical ICU.

Patients: Patients receiving NIV for ARF in the context of CRF or hypoxic ARF and patients with persistent weaning failure receiving NIV just after extubation.

Measurements: HME and HH were randomly compared during 2 NIV periods of 30 minutes separated by a 20 to 30 minutes period of spontaneous breathing with oxygen. ABG were collected at baseline and at the end of each period. As well as respiratory parameters including volumes, pressures, P0.1, a comfort score, capnometry and oxygen saturation. Two sets of patients were successively studied whether they have a flex tube added to the ventilatory circuit or not.

Study Type

Interventional

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
- - Bordeaux, France, 33076
    - Département de Réanimation Médicale, Hôpital Pellegrin-Tripode, Place A. Raba Léon,

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients receiving NIV for ARF in the context of CRF, hypoxic ARF or patients with persistent weaning failure receiving NIV just after extubation

Exclusion Criteria:

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Air blood gases at the end of each study period (one with HME, one with HH)

Secondary Outcome Measures

Outcome Measure
Respiratory parameters including volumes, pressures, P0.1, a comfort score, capnometry and oxygen saturation at the end of each study period (one with HME, one with HH)

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Investigators

Principal Investigator: alexandre Boyer, Dr, University Hospital, Bordeaux

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

June 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 9, 2013

Last Update Submitted That Met QC Criteria

May 7, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

9300-02

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.