NCT01489150

Brief Summary

In patients treated by Non invasive ventilation (NIV) due to acute hypercapnic respiratory failure, the interest of using the End-tidal Co2 measurement device "Capnostream" to evaluate PaCo2 and PaCo2 variations over time will be evaluated. Measurements will be done under normal expiration and under prolonged active and passive expiration maneuvers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2011

Shorter than P25 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

December 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

December 2, 2011

Last Update Submit

May 15, 2013

Conditions

Hypercapnic Respiratory Failure

Keywords

Acute respiratory failureHypercapniaNon invasive ventilationEnd-tidal CO2

Outcome Measures

Primary Outcomes (1)

  • Comparison between EtCO2,PaCO2 and PaCO2 variation under NIV during both spontaneous expiration and prolonged expiration

    Comparison between EtCO2,PaCO2 and PaCO2 variation under NIV during both spontaneous expiration and prolonged expiration

    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 arterial line requiring non invasive ventilation because of acute hypercapnic respiratory failure

You may qualify if:

  • ICU patient equipped with arterial line
  • NIV requirement
  • Hypercapnia: PaCO2 \> 45mmhg

You may not qualify if:

  • Severe hemodynamic instability
  • Severe psychiatric disorders
  • nasal lesions
  • denied consent

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

Related Publications (1)

  • Piquilloud L, Thevoz D, Jolliet P, Revelly JP. End-tidal carbon dioxide monitoring using a naso-buccal sensor is not appropriate to monitor capnia during non-invasive ventilation. Ann Intensive Care. 2015 Feb 12;5:2. doi: 10.1186/s13613-014-0042-8. eCollection 2015.

    PMID: 25852962DERIVED

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, Professor

    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

December 2, 2011

First Posted

December 9, 2011

Study Start

December 1, 2011

Primary Completion

April 1, 2012

Study Completion

December 1, 2012

Last Updated

May 16, 2013

Record last verified: 2013-05

Locations

CH(1)