Comparison of Humidification Devices During Non Invasive Ventilation, in Acute Respiratory Failure
NCT ID: NCT00190346
Last Updated: 2011-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
250 participants
INTERVENTIONAL
2001-12-31
2003-04-30
Brief Summary
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The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comparison with HH.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Interventions
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Humidification devices: HH vs HME
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Nicolas Best
Role: STUDY_CHAIR
DRRC hopitaux de Paris
Locations
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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
Réanimation Médicale - Centre Hospitalier Intercommunal de Poissy
Poissy, , France
Réanimation Médicale, Hôpital Charles Nicolle
Rouen, , France
Istituto di anestesiologia e Rianimazione - Università Cattolica Policlinico A. Gemelli
Roma, , Italy
Réanimation Polyvalente - CHU Fatima Bourguiba
Monastir, , Tunisia
Countries
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References
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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.
Other Identifiers
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PHRC 2001
Identifier Type: -
Identifier Source: org_study_id