Back to resultsMedical Gas Humidification During Noninvasive Mechanical Ventilation
Primary Purpose
Respiration, Artificial, Critical Illness
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MR730
Sponsored by
About this trial
This is an interventional treatment trial for Respiration, Artificial focused on measuring temperature, humidity, non invasive mechanical ventilation
Eligibility Criteria
Inclusion Criteria: Critically ill patients requiring non invasive mechanical ventilation Exclusion Criteria: Comatose patients
Sites / Locations
- Policlinico Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
The level of temperature and humidity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00124345
Brief Title
Medical Gas Humidification During Noninvasive Mechanical Ventilation
Official Title
The Humidification During Noninvasive Mechanical Ventilation Delivered by Helmet
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Policlinico Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, the investigators aimed to study the role of medical gas humidification during noninvasive mechanical ventilation.
Detailed Description
The medical gases are usually dry and cold thus when they are used during invasive mechanical ventilation they must be conditioned. No data are present on the necessity to condition the medical gases during non invasive mechanical ventilation. In this study the investigators studied the humidity and the temperature of the medical gases with and without any conditioning during non invasive mechanical ventilation in a group of healthy subjects and critically ill patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration, Artificial, Critical Illness
Keywords
temperature, humidity, non invasive mechanical ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MR730
Intervention Description
humidity measurement inside the helmet by a capacitative hygrometer and evaluation of patients' comfort
Primary Outcome Measure Information:
Title
The level of temperature and humidity
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Critically ill patients requiring non invasive mechanical ventilation
Exclusion Criteria:
Comatose patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davide Chiumello, MD
Organizational Affiliation
Policlinico Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Hospital
City
Milano
ZIP/Postal Code
20122
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Medical Gas Humidification During Noninvasive Mechanical Ventilation
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