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Medical Gas Humidification During Noninvasive Mechanical Ventilation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00124345
First Posted: July 27, 2005
Last Update Posted: September 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Policlinico Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Critically ill patients requiring non invasive mechanical ventilation

Exclusion Criteria:

  • Comatose patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124345


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

Responsible Party: Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00124345     History of Changes
Other Study ID Numbers: 1457
First Submitted: July 26, 2005
First Posted: July 27, 2005
Last Update Posted: September 25, 2008
Last Verified: September 2008

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes