Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Complications; Obstructive Sleep Apnea
• Intervention / Treatment: Procedure: Elective surgical procedure under general anesthesia

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Çiğdem Tütüncü, Prof. Dr.; Phone Number: +905325920584; Email: actutuncu@gmail.com
• Study Contact Backup: Name: Demet Laflı Tunay, Dr.; Phone Number: +905358685831; Email: dlafli@yahoo.com

Study Locations

• Turkey
  • Sariçam
    • Adana, Sariçam, Turkey, 01100
      • Çukurova University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSAS patients with postoperative pulmonary complication; 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; The incidence of postoperative pulmonary complications in OSAS patients undergoing elective surgery under general anesthesia will be determined.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Cukurova University
• Collaborators: Baskent University; Celal Bayar University; Acibadem University; Istanbul University - Cerrahpasa (IUC)
• Investigators: Study Director: Çiğdem Tütüncü, Prof. Dr., İstanbul University, Cerrahpaşa, Faculty of Medicine; Principal Investigator: Demet Laflı Tunay, Dr., Cukurova University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2023
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; general anesthesia; postoperative pulmonary complications
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: POPCSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be anonymized by the local researcher. Therefore, data collection will be pseudonymous and the patient's name will not appear on any case report form or other study document. All collected data will be kept confidential. This study will be conducted in accordance with the revision of the Declaration of Helsinki (2008). ICH-GCP will be strictly adhered to.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No