NCT01692509

Brief Summary

The practices and processes related to the administration of noninvasive ventilation (NIV) in the adult intensive care unit (ICU) of the University hospital of Lausanne will be recorded by an investigator at the bedside. The effect of the NIV treatment on various respiratory parameters ( respiratory rate, expired tidal volume, minute ventilation) will also be recorded using a pneumotachograph. Finally patient's comfort during NIV treatment will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

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

April 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

September 20, 2012

Last Update Submit

June 7, 2015

Conditions

Respiratory Failure Requiring Non Invasive Ventilation

Keywords

Non invasive ventilationRespiratory failureRespiratory comfort

Outcome Measures

Primary Outcomes (1)

  • Documentation of practices and processes related to NIV treatment

    Documentation of practices and processes related to NIV administration in the adult intensive care unit(type of ventilator used, type of interface chosen, initial settings, organization of the care team and interactions between caregivers).

Secondary Outcomes (2)

  • Patient's Respiratory comfort

  • Ventilatory parameters

Study Arms (1)

Patients requiring NIV

Patients requiring NIV because of acute respiratory failure

Eligibility Criteria

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

Adult patients hospitalized in the CHUV intensive care unit who require non invasive ventilation because of respiratory failure.

You may qualify if:

  • Respiratory failure
  • Therapeutic treatment by NIV required

You may not qualify if:

  • Age \< 18 years old
  • Prophylactic NIV treatment
  • Continuous Positive Airway Pressure (CPAP)treatment
  • Denied consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive care and burn unit, University Hospital of Lausanne

Lausanne, Switzerland

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Philippe Jolliet, Professor

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 25, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations

CH(1)