Clinical trial NCT04345354: 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.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Abdominal Surgery
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

* 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,

Primary outcomes:
measure: Evaluate rate of respiratory complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment
timeFrame: 7 days
measure: Evaluate rate of respiratory complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment
timeFrame: 7 days
measure: Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment
timeFrame: 7 days
measure: Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment
timeFrame: 7 days
Secondary outcomes:
measure: Evaluate tolerance and observance of continuous positive airway pressure treatment
timeFrame: 7 days
measure: Evaluate the feasibility of the ApneaLink
timeFrame: 7 days
measure: Evaluate the prevalence of obstructive sleep apnea-hypopnea syndrome patients to the severity level of the STOPBANG score,
timeFrame: 7 days
measure: Evaluate the duration and place of hospitalization during the post-surgical course
timeFrame: 28 days
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu de Poitiers
Study officials:
affiliation: Poitiers University Hospital
name: Jean-Claude MEURICE
role: PRINCIPAL_INVESTIGATOR
References: