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.

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04345354

Acronym

APNOSIS-BIS

Enrollment

Registered

2020-04-14

Start date

2016-06-14

Completion date

2018-12-31

Last updated

2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Abdominal Surgery

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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,

Design outcomes

Primary

Measure	Time frame
Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment	7 days
Evaluate rate of respiratory complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment	7 days
Evaluate rate of respiratory complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment	7 days
Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment	7 days

Secondary

Measure	Time frame
Evaluate tolerance and observance of continuous positive airway pressure treatment	7 days
Evaluate the feasibility of the ApneaLink	7 days
Evaluate the prevalence of obstructive sleep apnea-hypopnea syndrome patients to the severity level of the STOPBANG score,	7 days
Evaluate the duration and place of hospitalization during the post-surgical course	28 days

Countries

France

Outcome results