NCT02111876

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 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

September 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 8, 2025

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

March 10, 2014

Last Update Submit

September 1, 2025

Conditions

Keywords

ICU, COPD, OHS, OSA, heart failure

Outcome Measures

Primary Outcomes (2)

  • Sleep apnea syndrome

    Apnea-Hypopnea Index defined by polysomnography

    at 2 month after ICU discharge

  • Sleep Hypoventilation

    defined by AASM 2012 criteria with transcutaneous PtCO2 monitoring

    at 2 month after ICU discharge

Secondary Outcomes (4)

  • Lung physiology ( obstructive or restrictive lung disease)

    at week 2 after ICU discharge

  • Inspiratory Muscle Strength

    at week 2 after ICU discharge

  • Cardiac function

    at week 2 after ICU discharge

  • Hospital and ICU readmission rate

    1 year follow-up after ICu discharge

Study Arms (1)

AHRF follow-up

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • iatrogenic hypercpania pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Genpve

Geneva, 1211, Switzerland

Location

Related Publications (2)

  • Karege G, Zekry D, Allali G, Adler D, Marti C. Gait speed is associated with death or readmission among patients surviving acute hypercapnic respiratory failure. BMJ Open Respir Res. 2020 Jun;7(1):e000542. doi: 10.1136/bmjresp-2019-000542.

  • Adler D, Pepin JL, Dupuis-Lozeron E, Espa-Cervena K, Merlet-Violet R, Muller H, Janssens JP, Brochard L. Comorbidities and Subgroups of Patients Surviving Severe Acute Hypercapnic Respiratory Failure in the Intensive Care Unit. Am J Respir Crit Care Med. 2017 Jul 15;196(2):200-207. doi: 10.1164/rccm.201608-1666OC.

MeSH Terms

Conditions

Respiratory InsufficiencyPulmonary Disease, Chronic ObstructiveSleep Apnea, ObstructiveHeart Failure

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Apnea SyndromesApneaSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Adler E Adler, M.D.

    HUG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

April 11, 2014

Study Start

September 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 8, 2025

Record last verified: 2014-04

Locations