Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients

Not yet recruiting

• Conditions: Obstructive Sleep Apnea; Postoperative Complications
• Interventions: Procedure: Elective surgical procedure under general anesthesia

• Registration Number: NCT06041750
• Lead Sponsor: Cukurova University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Study First Posted: 2023-09-18
• Last Update Posted: 2023-09-18
• Study Start: 2023-10-15
• Primary Completion: 2024-12-15
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OSAS patients with postoperative pulmonary complication	Elective surgical procedure under general anesthesia	American Society of Anesthesiologists (ASA) physical 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. In this patient group, the incidence of postoperative early-period and long-term pulmonary complications will be investigated.

Primary Outcome Measures

Name	Time	Method
postoperative pulmonary complications	Postoperative day 1, 2, 7 and 30.	The rate of postoperative hypoxia (respiratory failure), atelectasis, pulmonary edema /embolus, aspiration, bronchospasm, respiratory infection / pneumonia, pleural effusion, pneumothorax, respiratory arrest will be measured

Secondary Outcome Measures

Name	Time	Method
Mortality	Postoperative day 30.	Mortality rate
Non-invasive/invasive mechanical ventilation requirement	Postoperative day 1, 2, 7 and 30.	Determination of the need for non-invasive or invasive mechanical ventilation beyond clinical standards.
Intensive care unit admission	Postoperative day 1, 2, 7 and 30.	Intensive care unit admission for respiratory indication
Predictive factors	Postoperative day 1, 2, 7 and 30.	Determination of patient, anesthesia and surgery-related predictive factors affecting the development of postoperative pulmonary complications.

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Sariçam, Turkey