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NCT02111876 Clinical Trial

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

Acute Hypercapnic Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02111876
Other study ID # CE 11-238
Secondary ID LIgue Pulmonaire
Status Recruiting
Phase N/A
First received March 10, 2014
Last updated April 9, 2014
Start date September 2012

Study information
Verified date April 2014
Source Ligue Pulmonaire Genevoise
Contact n/a
Is FDA regulated No
Health authority Switzerland: Hopitaux Universitaires de GenèveSwitzerland: Ligue Pulmonaire Genevoise
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- iatrogenic hypercpania pregnant woman

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Hôpitaux Universitaires de Genpve Geneva

Sponsors (2)
Lead Sponsor Collaborator
Ligue Pulmonaire Genevoise University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep apnea syndrome Apnea-Hypopnea Index defined by polysomnography at 2 month after ICU discharge No
Primary Sleep Hypoventilation defined by AASM 2012 criteria with transcutaneous PtCO2 monitoring at 2 month after ICU discharge No
Secondary Lung physiology ( obstructive or restrictive lung disease) FEV1, VC, TLC, DLCO at week 2 after ICU discharge No
Secondary Inspiratory Muscle Strength Sniff nasal maximal inspiratory pressure, Mouth inspiratory pressure at week 2 after ICU discharge No
Secondary Cardiac function Systolic and diastolic cardiac function, pulmonary hypertension at week 2 after ICU discharge No
Secondary Hospital and ICU readmission rate 1 year follow-up after ICu discharge No
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