NCT00221819

Brief Summary

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.

Trial Health

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Trial Health Score

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

Timeline
Completed

Started Jun 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

May 9, 2013

Status Verified

May 1, 2013

Enrollment Period

6 months

First QC Date

September 20, 2005

Last Update Submit

May 7, 2013

Conditions

Acute Lung InjuryPneumoniaChronic Obstructive Pulmonary DiseaseAcute Heart Failure

Keywords

HumidificationHeat and moisture exchangerHeated humidifier, non invasive ventilation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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)

Interventions

heated humidifier (device)DEVICE
Heat and moisture exchanger (device)DEVICE

Eligibility Criteria

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Acute Lung InjuryPneumoniaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsInfectionsLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • alexandre Boyer, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

June 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

May 9, 2013

Record last verified: 2013-05

Locations

FR(1)