Major Abdominal SurgeryAPNOSIS-BISNCT04345354
Observational Study of the Value of Using Obstructive Sleep Apnea-hypopnea Syndrome (CPAP) Ventilation on the Occurrence of Respiratory and Cardiovascular Complications in Patients at High Risk of Obstructive Apnea Syndrome During Postoperative Sleep Surgery of a Major Abdominal Surgery.
An observational study of Major Abdominal Surgery, run by Poitiers University Hospital at 1 site in France.
Trial summary
The presence of an obstructive sleep apnea-hypopnea syndrome (OSAHS) is a perfectly identified cardiovascular and metabolic risk factor responsible for excess mortality in patients with severe OSAHS, while life expectancy, when the SAHOS is treated by continuous positive airway pressure (CPAP) is close to that of the… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Major Abdominal Surgery
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2016to Dec 2018
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients without known obstructive sleep apnea-hypopnea syndrome, presenting at anesthesia consultation for visceral surgery to be performed at least within 10 days.
Who may be able to join
- Patients over 18 years old and naive to any treatment with obstructive sleep apnea-hypopnea syndrome,
- Patients at high risk of obstructive sleep apnea-hypopnea syndrome (STOP BANG ≥ 3),
- Patients scheduled for major abdominal surgery (all intraperitoneal surgeries excluding vesicles, eventrations and hernias, all aortic surgeries excluding endovascular surgeries) within a minimum of 10 days,
- It is possible to integrate the explanations concerning the realization of the ApneaLink ™ Air in autonomy and to ensure its restitution under 24-48h,
Who cannot join
- Patients with obstructive sleep apnea-hypopnea syndrome diagnosed before surgery,
- Patients with heart failure (NYHA> II),
- Patients with moderate to severe COPD
- Patients participating in a clinical trial,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of the Value of Using Continuous Positive Airway Pressure (CPAP) Ventilation on the Occurrence of Respiratory and Cardiovascular Complications in Patients at High Risk of Obstructive Apnea Syndrome During Postoperative Sleep Surgery of a Major Abdominal Surgery.
The presence of an obstructive sleep apnea-hypopnea syndrome (OSAHS) is a perfectly identified cardiovascular and metabolic risk factor responsible for excess mortality in patients with severe OSAHS, while life expectancy, when the SAHOS is treated by continuous positive airway pressure (CPAP) is close to that of the general population. It also represents a factor of excess mortality, little known and poorly explored, in relation to morbidity and mortality occurring during the perioperative period accompanying any general anesthesia.
- Conditions
- Major Abdominal Surgery
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 |
|---|---|---|
| Patient with continuous positive airway pressure treatment | Not described | |
| without continuous positive airway pressure treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate rate of respiratory complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment
Measured: 7 days
Evaluate rate of respiratory complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment
Measured: 7 days
Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment
Measured: 7 days
Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment
Measured: 7 days
Secondary outcomes (4)
Evaluate tolerance and observance of continuous positive airway pressure treatment
Measured: 7 days
Evaluate the feasibility of the ApneaLink
Measured: 7 days
Evaluate the prevalence of obstructive sleep apnea-hypopnea syndrome patients to the severity level of the STOPBANG score,
Measured: 7 days
Evaluate the duration and place of hospitalization during the post-surgical course
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start14 Jun 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Claude MEURICE, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345354
- Sponsor's protocol ID
- APNOSIS-BIS
- Acronym
- APNOSIS-BIS
- Status last verified
- Apr 2020
- First submitted
- 6 Aug 2018
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Value of Using Continuous Positive Airway Pressure (CPAP) Ventilation on the Occurrence of Respiratory and Cardiovascular Complications in Patients at High Risk of Obstructive Apnea Syndrome During Postoperative Sleep Surgery of a Major Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT04345354
- Acronym / sponsor ID
- APNOSIS-BIS / APNOSIS-BIS
- Conditions
- Major Abdominal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 Apr 2020 (actual)
- 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.
The presence of an obstructive sleep apnea-hypopnea syndrome (OSAHS) is a perfectly identified cardiovascular and metabolic risk factor responsible for excess mortality in patients with severe OSAHS, while life expectancy, when the SAHOS is treated by continuous positive airway pressure (CPAP) is close to that of the general population. It also represents a factor of excess mortality, little known and poorly explored, in relation to morbidity and mortality occurring during the perioperative period accompanying any general anesthesia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with continuous positive airway pressure treatment | – | – |
| without continuous positive airway pressure treatment | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients without known obstructive sleep apnea-hypopnea syndrome, presenting at anesthesia consultation for visceral surgery to be performed at least within 10 days.
Key inclusion criteria (4 listed)
- Patients over 18 years old and naive to any treatment with obstructive sleep apnea-hypopnea syndrome,
- Patients at high risk of obstructive sleep apnea-hypopnea syndrome (STOP BANG ≥ 3),
- Patients scheduled for major abdominal surgery (all intraperitoneal surgeries excluding vesicles, eventrations and hernias, all aortic surgeries excluding endovascular surgeries) within a minimum of 10 days,
- It is possible to integrate the explanations concerning the realization of the ApneaLink ™ Air in autonomy and to ensure its restitution under 24-48h,
Key exclusion criteria (4 listed)
- Patients with obstructive sleep apnea-hypopnea syndrome diagnosed before surgery,
- Patients with heart failure (NYHA> II),
- Patients with moderate to severe COPD
- Patients participating in a clinical trial,
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
Evaluate rate of respiratory complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment
Time frame: 7 days
Evaluate rate of respiratory complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment
Time frame: 7 days
Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment
Time frame: 7 days
Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment
Time frame: 7 days
4 secondary outcomes
Evaluate tolerance and observance of continuous positive airway pressure treatment
Time frame: 7 days
Evaluate the feasibility of the ApneaLink
Time frame: 7 days
Evaluate the prevalence of obstructive sleep apnea-hypopnea syndrome patients to the severity level of the STOPBANG score,
Time frame: 7 days
Evaluate the duration and place of hospitalization during the post-surgical course
Time frame: 28 days
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 14 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Jean-Claude MEURICE principal investigator
Poitiers University Hospital
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 Major Abdominal Surgery, run by Poitiers University Hospital at 1 site in France.
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 4 inclusion and 4 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 14 Apr 2020. 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 France. 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?
Evaluate rate of respiratory complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2020.