NCT00124345

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2008

Enrollment Period

2.4 years

First QC Date

July 26, 2005

Last Update Submit

September 24, 2008

Conditions

Respiration, ArtificialCritical Illness

Keywords

temperaturehumiditynon invasive mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • The level of temperature and humidity

    5 minutes

Study Arms (1)

1

EXPERIMENTAL
Device: MR730

Interventions

MR730DEVICE

humidity measurement inside the helmet by a capacitative hygrometer and evaluation of patients' comfort

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Critically ill patients requiring non invasive mechanical ventilation

You may not qualify if:

  • Comatose patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Hospital

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Respiratory AspirationCritical Illness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Davide Chiumello, MD

    Policlinico Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2005

First Posted

July 27, 2005

Study Start

June 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

IT(1)