Systematic Follow-up of Patients Surviving an Episode of Acute Hypercapnic Respiratory Failure in the ICU

April 9, 2014 updated by: Ligue Pulmonaire Genevoise

There is currently no good description of patients surviving an episode of acute hypercapnic respiratory failure in the ICU. For instance, the prevalence of OSA and sleep hypoventilation in a stable clinical condition is not known in this population.

This prospective cohort describes the clinical profile, predictors of readmission (followed over a year), and the prevalence of sleep-related breathing disorders (polysomnography in a stable clinical condition 3 months after ICU discharge) in patients treated for an episode of acute hypercapnic respiratory failure in the ICU.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Recruiting
        • Hôpitaux Universitaires de Genpve
        • Contact:
        • Principal Investigator:
          • Dan E Adler, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients surviving an episode of acute hypercapnic respiratory failure in the ICU

Description

Inclusion Criteria:

  • > 18 years Informed consent surviving an episode of acute hypercapnic respiratory failure

Exclusion Criteria:

  • iatrogenic hypercpania pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
AHRF follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep apnea syndrome
Time Frame: at 2 month after ICU discharge
Apnea-Hypopnea Index defined by polysomnography
at 2 month after ICU discharge
Sleep Hypoventilation
Time Frame: at 2 month after ICU discharge
defined by AASM 2012 criteria with transcutaneous PtCO2 monitoring
at 2 month after ICU discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung physiology ( obstructive or restrictive lung disease)
Time Frame: at week 2 after ICU discharge
FEV1, VC, TLC, DLCO
at week 2 after ICU discharge
Inspiratory Muscle Strength
Time Frame: at week 2 after ICU discharge
Sniff nasal maximal inspiratory pressure, Mouth inspiratory pressure
at week 2 after ICU discharge
Cardiac function
Time Frame: at week 2 after ICU discharge
Systolic and diastolic cardiac function, pulmonary hypertension
at week 2 after ICU discharge
Hospital and ICU readmission rate
Time Frame: 1 year follow-up after ICu discharge
1 year follow-up after ICu discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ligue Pulmonaire Genevoise

Collaborators

University Hospital, Geneva

Investigators

  • Principal Investigator: Adler E Adler, M.D., HUG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

March 10, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Estimate)

April 11, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 11-238
  • LIgue Pulmonaire Genevoise (Other Grant/Funding Number: Ligue Pulmonaire Genevoise)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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