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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00190346 |
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.
Condition | Intervention |
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Respiratory Failure COPD Hypoxemia Non Invasive Ventilation |
Device: Humidification devices: HH vs HME |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized RCT Comparing HH and HME During NIV in Acute Respiratory Failure |
Estimated Enrollment: | 250 |
Study Start Date: | December 2001 |
Estimated Study Completion Date: | April 2003 |
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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
TWO OR THREE following criteria :
Exclusion Criteria:
Canada | |
Département d'Anesthésie – Hôpital de l'Enfant Jésus | |
Quebec, Canada | |
France | |
Hôpital Georges Pompidou HEGP | |
Paris, France | |
Réanimation Médicale, Hôpital Charles Nicolle | |
Rouen, France | |
Réanimation du Service de Pneumologie – Centre Hospitalier Beaujon | |
Clichy, France | |
CHU de La Cavale Blanche | |
Brest, France | |
Hôpital Victor Dupouy, Argenteuil | |
Argenteuil, France | |
Réanimation pneumologique, Hôpital Pitié Salpétrière | |
Paris, France | |
Réanimation Médicale – Hôpital Louis Mourier | |
Colombes, France | |
Département d'Anesthésie-Réanimation "B" – CHU Saint Eloi | |
Montpellier, France | |
Réanimation du Service Pneumologie - Hôtel Dieu | |
Paris, France | |
Réanimation Pneumologique– CHU Tenon | |
Paris, France | |
Réanimation Médicale - Centre Hospitalier Intercommunal de Poissy | |
Poissy, France | |
Italy | |
Istituto di anestesiologia e Rianimazione - Università Cattolica Policlinico A. Gemelli | |
Roma, Italy | |
Tunisia | |
Réanimation Polyvalente – CHU Fatima Bourguiba | |
Monastir, Tunisia |
Study Chair: | Nicolas Best | DRRC hopitaux de Paris |
Study ID Numbers: | PHRC 2001 |
Study First Received: | September 13, 2005 |
Last Updated: | December 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00190346 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Acute respiratory distress with hypercapnia with hypoxemia requiring NIV |
Respiratory Insufficiency Respiratory Tract Diseases Hypercapnia Lung Diseases |
Respiration Disorders Respiratory Distress Syndrome, Adult Acute respiratory distress syndrome |