Acute Hypercapnic Respiratory FailureNCT02111876
Systematic Follow-up of Patients Surviving an Episode of Acute Hypercapnic Respiratory Failure in the ICU
An observational study of Acute Hypercapnic Respiratory Failure, run by Ligue Pulmonaire Genevoise at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypercapnic Respiratory Failure
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2012to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients surviving an episode of acute hypercapnic respiratory failure in the ICU
Who may be able to join
- > 18 years Informed consent surviving an episode of acute hypercapnic respiratory failure
Who cannot join
- iatrogenic hypercpania pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Hypercapnic Respiratory Failure
- Keywords
- ICU, COPD, OHS, OSA, heart failure
- Medical subject headings
- Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive, Sleep Apnea, Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AHRF follow-up | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep apnea syndrome
Apnea-Hypopnea Index defined by polysomnography
Measured: at 2 month after ICU discharge
Sleep Hypoventilation
defined by AASM 2012 criteria with transcutaneous PtCO2 monitoring
Measured: at 2 month after ICU discharge
Secondary outcomes (4)
Lung physiology ( obstructive or restrictive lung disease)
FEV1, VC, TLC, DLCO
Measured: at week 2 after ICU discharge
Inspiratory Muscle Strength
Sniff nasal maximal inspiratory pressure, Mouth inspiratory pressure
Measured: at week 2 after ICU discharge
Cardiac function
Systolic and diastolic cardiac function, pulmonary hypertension
Measured: at week 2 after ICU discharge
Hospital and ICU readmission rate
Measured: 1 year follow-up after ICu discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startSep 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligue Pulmonaire Genevoise
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Adler E Adler, M.D., Principal investigator, HUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111876
- Sponsor's protocol ID
- CE 11-238
- Other IDs
- LIgue Pulmonaire Genevoise
- Status last verified
- Apr 2014
- First submitted
- 10 Mar 2014
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32561512Adler 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.
PubMed 27973930
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Follow-up of Patients Surviving an Episode of Acute Hypercapnic Respiratory Failure in the ICU
- ClinicalTrials.gov ID
- NCT02111876
- Acronym / sponsor ID
- CE 11-238
- Conditions
- Acute Hypercapnic Respiratory Failure
- Keywords
- ICU, COPD, OHS, OSA, heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ligue Pulmonaire GenevoiseUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AHRF follow-up | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients surviving an episode of acute hypercapnic respiratory failure in the ICU
Key inclusion criteria (1 listed)
- > 18 years Informed consent surviving an episode of acute hypercapnic respiratory failure
Key exclusion criteria (1 listed)
- iatrogenic hypercpania pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep apnea syndrome
Time frame: at 2 month after ICU discharge
Apnea-Hypopnea Index defined by polysomnography
Sleep Hypoventilation
Time frame: at 2 month after ICU discharge
defined by AASM 2012 criteria with transcutaneous PtCO2 monitoring
4 secondary outcomes
Lung physiology ( obstructive or restrictive lung disease)
Time frame: at week 2 after ICU discharge
Inspiratory Muscle Strength
Time frame: at week 2 after ICU discharge
Cardiac function
Time frame: at week 2 after ICU discharge
Hospital and ICU readmission rate
Time frame: 1 year follow-up after ICu discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 32561512Karege 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.
- Derived from this study: PubMed 27973930Adler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adler E Adler, M.D. principal investigator
HUG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hypercapnic Respiratory Failure, run by Ligue Pulmonaire Genevoise at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep apnea syndrome (time frame: at 2 month after ICU discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02111876, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.