Major Abdominal Surgery Clinical Trial
— APNOSIS-BISOfficial 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.
NCT number | NCT04345354 |
Other study ID # | APNOSIS-BIS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 14, 2016 |
Est. completion date | December 2018 |
Verified date | April 2020 |
Source | Poitiers University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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, |
Country | Name | City | State |
---|---|---|---|
France | Chu de Poitiers | Poitiers |
Lead Sponsor | Collaborator |
---|---|
Poitiers University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate rate of respiratory complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment | 7 days | ||
Primary | Evaluate rate of respiratory complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment | 7 days | ||
Primary | Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome with continuous positive airway pressure treatment | 7 days | ||
Primary | Evaluate rate of cardiovascular complications with moderate sleep apnea syndrome without continuous positive airway pressure treatment | 7 days | ||
Secondary | Evaluate tolerance and observance of continuous positive airway pressure treatment | 7 days | ||
Secondary | Evaluate the feasibility of the ApneaLink | 7 days | ||
Secondary | Evaluate the prevalence of obstructive sleep apnea-hypopnea syndrome patients to the severity level of the STOPBANG score, | 7 days | ||
Secondary | Evaluate the duration and place of hospitalization during the post-surgical course | 28 days |
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