Back to resultsGases Humidification During Noninvasive Ventilation : Heat and Moisture Exchanger or Heated Humidifier ?
Primary Purpose
Acute Lung Injury, Pneumonia, Chronic Obstructive Pulmonary Disease
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
heated humidifier (device)
Heat and moisture exchanger (device)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lung Injury focused on measuring Humidification, Heat and moisture exchanger, Heated humidifier, non invasive ventilation
Eligibility 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: -
Sites / Locations
- Département de Réanimation Médicale, Hôpital Pellegrin-Tripode, Place A. Raba Léon,
Outcomes
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)
Full Information
NCT ID
NCT00221819
First Posted
September 20, 2005
Last Updated
May 7, 2013
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT00221819
Brief Title
Gases Humidification During Noninvasive Ventilation : Heat and Moisture Exchanger or Heated Humidifier ?
Official Title
Prospective Study of the Influence of the Humidification Mode on Ventilation Parameters and Arterial Blood Gases in Non Invasive Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Pneumonia, Chronic Obstructive Pulmonary Disease, Acute Heart Failure
Keywords
Humidification, Heat and moisture exchanger, Heated humidifier, non invasive ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
heated humidifier (device)
Intervention Type
Device
Intervention Name(s)
Heat and moisture exchanger (device)
Primary Outcome Measure Information:
Title
Air blood gases at the end of each study period (one with HME, one with HH)
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alexandre Boyer, Dr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département de Réanimation Médicale, Hôpital Pellegrin-Tripode, Place A. Raba Léon,
City
Bordeaux
ZIP/Postal Code
33076
Country
France
12. IPD Sharing Statement
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Gases Humidification During Noninvasive Ventilation : Heat and Moisture Exchanger or Heated Humidifier ?
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