Gases Humidification During Noninvasive Ventilation : Heat and Moisture Exchanger or Heated Humidifier ?

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221819
First received: September 20, 2005
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

To humidify gases during non invasive ventilation, both to heated humidifier (HH) and heat and moisture exchanger (HME) are routinely used. Patients receiving non invasive ventilation for acute respiratory failure were randomized to HME or HH. The purpose of this study was to evaluate respiratory parameters and arterial blood gases (ABG) of patients during NIV with small dead space HME compared to HH.


Condition Intervention
Acute Lung Injury
Pneumonia
Chronic Obstructive Pulmonary Disease
Acute Heart Failure
Device: heated humidifier (device)
Device: Heat and moisture exchanger (device)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study of the Influence of the Humidification Mode on Ventilation Parameters and Arterial Blood Gases in Non Invasive Ventilation

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Air blood gases at the end of each study period (one with HME, one with HH)

Secondary Outcome Measures:
  • Respiratory parameters including volumes, pressures, P0.1, a comfort score, capnometry and oxygen saturation at the end of each study period (one with HME, one with HH)

Study Start Date: June 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Detailed Description:

Objective: Few data are reported in the field of noninvasive ventilation (NIV) regarding humidification devices. It was previously suggested that standard heat and moisture exchangers (HME) had adverse gasometrical and clinical outcomes in acute respiratory failure (ARF) of chronic respiratory failure patients (CRF). This study was performed to evaluate respiratory parameters and arterial blood gases (ABG) of patients during NIV with small dead space HME compared to heated humidifier (HH).

Design: Prospective randomized cross-over study. Setting: A 16-bed medical intensive care unit (ICU) and a 14-bed medico surgical ICU.

Patients: Patients receiving NIV for ARF in the context of CRF or hypoxic ARF and patients with persistent weaning failure receiving NIV just after extubation.

Measurements: HME and HH were randomly compared during 2 NIV periods of 30 minutes separated by a 20 to 30 minutes period of spontaneous breathing with oxygen. ABG were collected at baseline and at the end of each period. As well as respiratory parameters including volumes, pressures, P0.1, a comfort score, capnometry and oxygen saturation. Two sets of patients were successively studied whether they have a flex tube added to the ventilatory circuit or not.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients receiving NIV for ARF in the context of CRF, hypoxic ARF or patients with persistent weaning failure receiving NIV just after extubation

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221819

Locations
France
Département de Réanimation Médicale, Hôpital Pellegrin-Tripode, Place A. Raba Léon,
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: alexandre Boyer, Dr University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00221819     History of Changes
Other Study ID Numbers: 9300-02
Study First Received: September 20, 2005
Last Updated: May 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Humidification
Heat and moisture exchanger
Heated humidifier, non invasive ventilation

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Pneumonia
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Lung Diseases, Obstructive
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Thoracic Injuries

ClinicalTrials.gov processed this record on April 16, 2014