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

September 13, 2005
October 25, 2011
December 2001
Not Provided
Intubation rate [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
Intubation rate
Complete list of historical versions of study NCT00190346 on ClinicalTrials.gov Archive Site
  • -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 ]
  • -Physiological outcome at 1,3 and 6 hours (arterial blood gases, respiratory rate)
  • -Intolerance of NIV
  • - Frequency of VAP
  • - Duration of total MV duration
  • - ICU LOS
  • - Hospital LOS
  • - Mortality (ICU and hospital)
Not Provided
Not Provided
 
Comparison of Humidification Devices During Non Invasive Ventilation, in Acute Respiratory Failure
Randomized RCT Comparing HH and HME During NIV in Acute Respiratory Failure

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Respiratory Failure
  • COPD
  • Hypoxemia
  • Non Invasive Ventilation
Device: Humidification devices: HH vs HME
Not Provided
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, Taillé 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):211-9. doi: 10.1007/s00134-013-3145-z. Epub 2013 Nov 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
250
April 2003
Not Provided

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Italy,   Tunisia
 
NCT00190346
PHRC 2001
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Study Chair: Nicolas Best DRRC hopitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP