NCT00190346

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2001

Geographic Reach
4 countries

14 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

October 26, 2011

Status Verified

August 1, 2005

First QC Date

September 13, 2005

Last Update Submit

October 25, 2011

Conditions

Respiratory FailureCOPDHypoxemiaNon Invasive Ventilation

Keywords

Acute respiratory distresswith hypercapniawith hypoxemiarequiring NIV

Outcome Measures

Primary Outcomes (1)

  • Intubation rate

    during the study

Secondary Outcomes (7)

  • -Physiological outcome at 1,3 and 6 hours (arterial blood gases, respiratory rate)

    during the study

  • -Intolerance of NIV

    during the study

  • - Frequency of VAP

    during the study

  • - Duration of total MV duration

    during the study

  • - ICU LOS

    during the study

  • +2 more secondary outcomes

Interventions

Humidification devices: HH vs HMEDEVICE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Département d'Anesthésie - Hôpital de l'Enfant Jésus

Québec, Quebec, Canada

Location

Hôpital Victor Dupouy, Argenteuil

Argenteuil, France

Location

CHU de La Cavale Blanche

Brest, France

Location

Réanimation du Service de Pneumologie - Centre Hospitalier Beaujon

Clichy, France

Location

Réanimation Médicale - Hôpital Louis Mourier

Colombes, France

Location

Département d'Anesthésie-Réanimation "B" - CHU Saint Eloi

Montpellier, France

Location

Hôpital Georges Pompidou HEGP

Paris, France

Location

Réanimation du Service Pneumologie - Hôtel Dieu

Paris, France

Location

Réanimation pneumologique, Hôpital Pitié Salpétrière

Paris, France

Location

Réanimation Pneumologique- CHU Tenon

Paris, France

Location

Réanimation Médicale - Centre Hospitalier Intercommunal de Poissy

Poissy, France

Location

Réanimation Médicale, Hôpital Charles Nicolle

Rouen, France

Location

Istituto di anestesiologia e Rianimazione - Università Cattolica Policlinico A. Gemelli

Roma, Italy

Location

Réanimation Polyvalente - CHU Fatima Bourguiba

Monastir, Tunisia

Location

Related Publications (1)

  • Lellouche F, L'Her E, Abroug F, Deye N, Rodriguez PO, Rabbat A, Jaber S, Fartoukh M, Conti G, Cracco C, Richard JC, Ricard JD, Mal H, Mentec H, Loisel F, Lacherade JC, Taille S, Brochard L. Impact of the humidification device on intubation rate during noninvasive ventilation with ICU ventilators: results of a multicenter randomized controlled trial. Intensive Care Med. 2014 Feb;40(2):211-219. doi: 10.1007/s00134-013-3145-z. Epub 2013 Nov 26.

    PMID: 24275900DERIVED

MeSH Terms

Conditions

Respiratory InsufficiencyPulmonary Disease, Chronic ObstructiveHypoxiaAcute Lung Injury

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and SymptomsLung Injury

Study Officials

  • Nicolas Best

    DRRC hopitaux de Paris

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

December 1, 2001

Study Completion

April 1, 2003

Last Updated

October 26, 2011

Record last verified: 2005-08

Locations

TU(1)FR(11)CA(1)IT(1)