Clinical trial NCT00190346: Comparison of Humidification Devices During Non Invasive Ventilation, in Acute Respiratory Failure
Official title: Randomized RCT Comparing HH and HME During NIV in Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Failure
COPD
Hypoxemia
Non Invasive Ventilation
Keywords: Acute respiratory distress
with hypercapnia
with hypoxemia
requiring NIV
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: Inclusion Criteria:

* 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

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 outcomes:
measure: Intubation rate
timeFrame: during the study
Secondary outcomes:
measure: -Physiological outcome at 1,3 and 6 hours (arterial blood gases, respiratory rate)
timeFrame: during the study
measure: -Intolerance of NIV
timeFrame: during the study
measure: - Frequency of VAP
timeFrame: during the study
measure: - Duration of total MV duration
timeFrame: during the study
measure: - ICU LOS
timeFrame: during the study
measure: - Hospital LOS
timeFrame: during the study
measure: - Mortality (ICU and hospital)
timeFrame: during the study
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Département d'Anesthésie - Hôpital de l'Enfant Jésus
city: Argenteuil
country: France
facility: Hôpital Victor Dupouy, Argenteuil
city: Brest
country: France
facility: CHU de La Cavale Blanche
city: Clichy
country: France
facility: Réanimation du Service de Pneumologie - Centre Hospitalier Beaujon
city: Colombes
country: France
facility: Réanimation Médicale - Hôpital Louis Mourier
city: Montpellier
country: France
facility: Département d'Anesthésie-Réanimation "B" - CHU Saint Eloi
city: Paris
country: France
facility: Hôpital Georges Pompidou HEGP
city: Paris
country: France
facility: Réanimation du Service Pneumologie - Hôtel Dieu
city: Paris
country: France
facility: Réanimation pneumologique, Hôpital Pitié Salpétrière
city: Paris
country: France
facility: Réanimation Pneumologique- CHU Tenon
city: Poissy
country: France
facility: Réanimation Médicale - Centre Hospitalier Intercommunal de Poissy
city: Rouen
country: France
facility: Réanimation Médicale, Hôpital Charles Nicolle
city: Roma
country: Italy
facility: Istituto di anestesiologia e Rianimazione - Università Cattolica Policlinico A. Gemelli
city: Monastir
country: Tunisia
facility: Réanimation Polyvalente - CHU Fatima Bourguiba
Study officials:
affiliation: DRRC hopitaux de Paris
name: Nicolas Best
role: STUDY_CHAIR
References:
citation: 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.