Comparison of Humidification Devices During Non Invasive Ventilation, in Acute Respiratory Failure

Not Applicable

Terminated

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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

TWO OR THREE following criteria :

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Intubation rate	during the study

Secondary Outcome Measures

Name	Time	Method
-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
- Hospital LOS	during the study
- Mortality (ICU and hospital)	during the study

Locations (14): Réanimation Polyvalente - CHU Fatima Bourguiba
🇹🇳
Monastir, Tunisia
Réanimation Médicale - Hôpital Louis Mourier
🇫🇷
Colombes, France
Hôpital Victor Dupouy, Argenteuil
🇫🇷
Argenteuil, France
CHU de La Cavale Blanche
🇫🇷
Brest, France
Département d'Anesthésie-Réanimation "B" - CHU Saint Eloi
🇫🇷
Montpellier, France
Département d'Anesthésie - Hôpital de l'Enfant Jésus
🇨🇦
Quebec, Canada
Réanimation du Service de Pneumologie - Centre Hospitalier Beaujon
🇫🇷
Clichy, France
Réanimation pneumologique, Hôpital Pitié Salpétrière
🇫🇷
Paris, France
Réanimation du Service Pneumologie - Hôtel Dieu
🇫🇷
Paris, France
Réanimation Pneumologique- CHU Tenon
🇫🇷
Paris, France
Hôpital Georges Pompidou HEGP
🇫🇷
Paris, France
Istituto di anestesiologia e Rianimazione - Università Cattolica Policlinico A. Gemelli
🇮🇹
Roma, Italy
Réanimation Médicale, Hôpital Charles Nicolle
🇫🇷
Rouen, France
Réanimation Médicale - Centre Hospitalier Intercommunal de Poissy
🇫🇷
Poissy, France