Medical Gas Humidification During Noninvasive Mechanical Ventilation

Critical Illness Clinical Trial

Official title:

The Humidification During Noninvasive Mechanical Ventilation Delivered by Helmet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124345
• Other study ID #: 1457
• Status: Completed
• Phase: N/A
• First received: July 26, 2005
• Last updated: September 24, 2008
• Start date: June 2005
• Est. completion date: November 2007

Study information

• Verified date: September 2008
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Critically ill patients requiring non invasive mechanical ventilation

Exclusion Criteria:

• Comatose patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Respiration, Artificial

Intervention

Device:
• MR730
humidity measurement inside the helmet by a capacitative hygrometer and evaluation of patients' comfort

Locations

Country	Name	City	State
Italy	Policlinico Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of temperature and humidity		5 minutes	No