Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients

Study Overview
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Brief Summary
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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.

Official Title
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Predicting Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients; Multicentre, Prospective, Observational Cohort Study

Conditions
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Obstructive Sleep Apnea, Postoperative Complications

Intervention / Treatment
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* Procedure: Elective surgical procedure under general anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-65 years ASA physical status I-III Preoperative OSAS diagnosis (with polysomnography or STOP-BANG questionnaire score) Surgeries performed under general anesthesia Endotracheal intubation facilitated by neuromuscular blockers Exclusion Criteria: ASA physical status IV or V Planned admission to the ICU after surgery Cardiac Surgery Non-operating room anesthesia Neuromuscular disease Emergency or re-operational procedure Laryngectomy Pneumonectomy Invasive airway access Pregnancy Outpatient surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSAS patients with postoperative pulmonary complication<br>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. | Procedure: Elective surgical procedure under general anesthesia<br>* The incidence of postoperative pulmonary complications in OSAS patients undergoing elective surgery under general anesthesia will be determined.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, postoperative pulmonary complications, general anesthesia