Clinical trial NCT06041750: Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients
Official title: Predicting Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients; Multicentre, Prospective, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea
Postoperative Complications
Keywords: obstructive sleep apnea
postoperative pulmonary complications
general anesthesia
Lead sponsor: Cukurova University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
name: Acibadem University
name: Baskent University
name: Celal Bayar University
First posted: 2023-09-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA status I-III adult patients age between 18-65 years undergoing elective surgery with general anesthesia and diagnosis of OSAS will be recruited in this study.

Brief summary: It is known that perioperative respiratory complications occur more often in obstructive sleep apnea syndrome (OSAS) patients during general anesthesia. Although there are prospective RCTs in this area, the need for further and larger studies remains due to the heterogenity of the results. Moreover, the incidence of postoperative pulmonary complications in OSAS patients undergoing surgery in Turkey and the predictive factors affecting the respiratory adverse events are uncertain. Therefore, in this prospective observational cohort study, it was aimed to determine the incidence of postoperative pulmonary complications and the predictor factors associated with patient, anesthesia and surgery in surgical patients with a confirmed or highly suspected OSAS diagnosis undergoing general anesthesia.


Eligibility criteria: Inclusion Criteria:

1. Age: 18-65 years
2. ASA physical status I-III
3. Preoperative OSAS diagnosis (with polysomnography or STOP-BANG questionnaire score)
4. Surgeries performed under general anesthesia
5. Endotracheal intubation facilitated by neuromuscular blockers

Exclusion Criteria:

1. ASA physical status IV or V
2. Planned admission to the ICU after surgery
3. Cardiac Surgery
4. Non-operating room anesthesia
5. Neuromuscular disease
6. Emergency or re-operational procedure
7. Laryngectomy
8. Pneumonectomy
9. Invasive airway access
10. Pregnancy
11. Outpatient surgery

Primary outcomes:
measure: postoperative pulmonary complications
timeFrame: Postoperative day 1, 2, 7 and 30.
Secondary outcomes:
measure: Predictive factors
timeFrame: Postoperative day 1, 2, 7 and 30.
measure: Non-invasive/invasive mechanical ventilation requirement
timeFrame: Postoperative day 1, 2, 7 and 30.
measure: Intensive care unit admission
timeFrame: Postoperative day 1, 2, 7 and 30.
measure: Mortality
timeFrame: Postoperative day 30.
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Sariçam
Study officials:
affiliation: İstanbul University, Cerrahpaşa, Faculty of Medicine
name: Çiğdem Tütüncü, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Çukurova University, Faculty of Medicine
name: Demet Laflı Tunay, Dr.
role: PRINCIPAL_INVESTIGATOR
References: