Medical Gas Humidification During Noninvasive Mechanical Ventilation

This study has been completed.
Sponsor:
Information provided by:
Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT00124345
First received: July 26, 2005
Last updated: September 24, 2008
Last verified: September 2008
  Purpose

In this study, the investigators aimed to study the role of medical gas humidification during noninvasive mechanical ventilation.


Condition Intervention
Respiration, Artificial
Critical Illness
Device: MR730

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Humidification During Noninvasive Mechanical Ventilation Delivered by Helmet

Further study details as provided by Policlinico Hospital:

Primary Outcome Measures:
  • The level of temperature and humidity [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: June 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: MR730
humidity measurement inside the helmet by a capacitative hygrometer and evaluation of patients' comfort

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Critically ill patients requiring non invasive mechanical ventilation

Exclusion Criteria:

  • Comatose patients
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00124345

Locations
Italy
Policlinico Hospital
Milano, Italy, 20122
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Davide Chiumello, MD Policlinico Hospital
  More Information

No publications provided

Responsible Party: Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00124345     History of Changes
Other Study ID Numbers: 1457
Study First Received: July 26, 2005
Last Updated: September 24, 2008
Health Authority: Italy: Ministry of Health

Keywords provided by Policlinico Hospital:
temperature
humidity
non invasive mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014