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Medical Gas Humidification During Noninvasive Mechanical Ventilation

This study has been completed.

Sponsored by: Policlinico Hospital
Information provided by: Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00124345
  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

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
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

Arms Assigned Interventions
1: Active Comparator 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

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

Responsible Party:   Policlinico Hospital ( Davide Chiumello )
Study ID Numbers:   1457
First Received:   July 26, 2005
Last Updated:   December 18, 2007
ClinicalTrials.gov Identifier:   NCT00124345
Health Authority:   Italy: Ministry of Health

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

Study placed in the following topic categories:
Critical Illness

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 05, 2008




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