Medical Gas Humidification During Noninvasive Mechanical Ventilation - Tabular View

Tracking Information

First Received Date ^ICMJE

July 26, 2005

Last Updated Date

September 24, 2008

Start Date ^ICMJE

June 2005

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

The level of temperature and humidity

Change History

Complete list of historical versions of study NCT00124345 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Medical Gas Humidification During Noninvasive Mechanical Ventilation

Official Title ^ICMJE

The Humidification During Noninvasive Mechanical Ventilation Delivered by Helmet

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Respiration, Artificial
Critical Illness

Intervention ^ICMJE

Device: MR730

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Critically ill patients requiring non invasive mechanical ventilation

Exclusion Criteria:

Comatose patients

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00124345

Responsible Party

Davide Chiumello, Policlinico Hospital

Study ID Numbers ^ICMJE

1457

Study Sponsor ^ICMJE

Policlinico Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Davide Chiumello, MD

Policlinico Hospital

Information Provided By

Policlinico Hospital

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP