Loading clinical trials...
Loading clinical trials...
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.
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.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
Département d'Anesthésie - Hôpital de l'Enfant Jésus
Québec, Quebec, Canada
Hôpital Victor Dupouy, Argenteuil
Argenteuil, France
CHU de La Cavale Blanche
Brest, France
Réanimation du Service de Pneumologie - Centre Hospitalier Beaujon
Clichy, France
Réanimation Médicale - Hôpital Louis Mourier
Colombes, France
Département d'Anesthésie-Réanimation "B" - CHU Saint Eloi
Montpellier, 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
Paris, France
Start Date
December 1, 2001
Completion Date
April 1, 2003
Last Updated
October 26, 2011
250
Estimated participants
Humidification devices: HH vs HME
DEVICE
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
NCT07477600
NCT07462221
NCT07351929
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions