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

COPD Clinical Trial

Official title:

Randomized RCT Comparing HH and HME During NIV in Acute Respiratory Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00190346
• Other study ID #: PHRC 2001
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 25, 2011
• Start date: December 2001
• Est. completion date: April 2003

Study information

• Verified date: August 2005
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• COPD
• Hypoxemia
• Non Invasive Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Humidification devices: HH vs HME

Locations

Country	Name	City	State
Canada	Département d'Anesthésie - Hôpital de l'Enfant Jésus	Quebec
France	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
Italy	Istituto di anestesiologia e Rianimazione - Università Cattolica Policlinico A. Gemelli	Roma
Tunisia	Réanimation Polyvalente - CHU Fatima Bourguiba	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Countries where clinical trial is conducted

Canada,  France,  Italy,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation rate		during the study	Yes
Secondary	-Physiological outcome at 1,3 and 6 hours (arterial blood gases, respiratory rate)		during the study	Yes
Secondary	-Intolerance of NIV		during the study	Yes
Secondary	- Frequency of VAP		during the study	Yes
Secondary	- Duration of total MV duration		during the study	Yes
Secondary	- ICU LOS		during the study	Yes
Secondary	- Hospital LOS		during the study	Yes
Secondary	- Mortality (ICU and hospital)		during the study	Yes