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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190346
First received: September 13, 2005
Last updated: October 25, 2011
Last verified: August 2005
  Purpose

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
Respiratory Failure
COPD
Hypoxemia
Non Invasive Ventilation
Device: Humidification devices: HH vs HME

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Randomized RCT Comparing HH and HME During NIV in Acute Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Intubation rate [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • -Physiological outcome at 1,3 and 6 hours (arterial blood gases, respiratory rate) [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • -Intolerance of NIV [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • - Frequency of VAP [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • - Duration of total MV duration [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • - ICU LOS [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • - Hospital LOS [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • - Mortality (ICU and hospital) [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: December 2001
Estimated Study Completion Date: April 2003
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00190346

Locations
Canada
Département d'Anesthésie - Hôpital de l'Enfant Jésus
Quebec, Canada
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- CHU Tenon
Paris, France
Réanimation pneumologique, Hôpital Pitié Salpétrière
Paris, France
Réanimation Médicale - Centre Hospitalier Intercommunal de Poissy
Poissy, France
Réanimation Médicale, Hôpital Charles Nicolle
Rouen, France
Italy
Istituto di anestesiologia e Rianimazione - Università Cattolica Policlinico A. Gemelli
Roma, Italy
Tunisia
Réanimation Polyvalente - CHU Fatima Bourguiba
Monastir, Tunisia
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Nicolas Best DRRC hopitaux de Paris
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00190346     History of Changes
Other Study ID Numbers: PHRC 2001
Study First Received: September 13, 2005
Last Updated: October 25, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute respiratory distress
with hypercapnia
with hypoxemia
requiring NIV

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Anoxia
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014