NCT01857635

Brief Summary

In patients suffering from hypercapnic respiratory failure and treated by non invasive ventilation (NIV), the interest of using transcutaneous CO2 measurement to evaluate PaCO2 and PaCO2 variation over time is unknown and will be evaluated in this study. Measurements will be done during one-hour NIV treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Typical duration 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

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

2.1 years

First QC Date

May 15, 2013

Last Update Submit

June 7, 2015

Conditions

Hypercapnic Respiratory Failure

Keywords

Acute respiratory failureHypercapniaNon invasive ventilationTranscutaneous CO2 measurement

Outcome Measures

Primary Outcomes (1)

  • Comparison between TpCO2 (transcutaneous non invasive CO2 partial pressure measurement) and PaCO2 (obtained by blood gas analysis) values during NIV treatment.

    sixty minutes

Eligibility Criteria

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

Intensive care unit patients equipped with an arterial line and requiring non invasive ventilation because of acute hypercapnic respiratory failure

You may qualify if:

  • ICU patient equipped with an arterial line
  • NIV treatment prescribed by the clinician in charge
  • Hypercapnia defined by PaCO2\> 42mmHg

You may not qualify if:

  • Severe hemodynamic instability
  • Severe psychiatric disorders
  • Denied consent
  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive care and burn unit, University hospital of Lausanne

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Respiratory InsufficiencyHypercapnia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Philippe Jolliet, Prof

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 20, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations

CH(1)