NCT00297986

Brief Summary

In this study the investigators aimed to study the ventilatory performance of different interfaces during NPPV delivering.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2004

Longer than P75 for all trials

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, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2006

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

10.5 years

First QC Date

February 27, 2006

Last Update Submit

April 27, 2015

Conditions

Respiratory FailureHealthy

Study Arms (1)

1

healthy subjects

Device: Helmet

Interventions

HelmetDEVICE

Evaluation of different interfaces for NPPV

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy subjects

You may qualify if:

  • Adult healthy subjects

You may not qualify if:

  • Barotrauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Hospital

Milan, Italy

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Head Protective Devices

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Personal Protective EquipmentProtective DevicesEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Davide Chiumello, MD

    Policlinico Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 27, 2006

First Posted

March 1, 2006

Study Start

June 1, 2004

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

IT(1)