Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients

NCT06041750 | Unknown DMC

• 1 other identifier: POPCSA
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Postoperative Complications

Keywords

obstructive sleep apnea; postoperative pulmonary complications; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Predictive factors

  Postoperative day 1, 2, 7 and 30.

• Non-invasive/invasive mechanical ventilation requirement

  Postoperative day 1, 2, 7 and 30.

• Intensive care unit admission

  Postoperative day 1, 2, 7 and 30.

• Mortality

  Postoperative day 30.

Study Arms (1)

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

Interventions

Elective surgical procedure under general anesthesia PROCEDURE

The incidence of postoperative pulmonary complications in OSAS patients undergoing elective surgery under general anesthesia will be determined.

OSAS patients with postoperative pulmonary complication

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead
• Istanbul University - Cerrahpasa: collaborator
• Acibadem University: collaborator
• Baskent University: collaborator
• Celal Bayar University: collaborator

Study Sites (1)

Cukurova University

Adana, Sariçam, 01100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Postoperative Complications

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Çiğdem Tütüncü, Prof. Dr.

  İstanbul University, Cerrahpaşa, Faculty of Medicine

  STUDY DIRECTOR

• Demet Laflı Tunay, Dr.

  Çukurova University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Çiğdem Tütüncü, Prof. Dr.

CONTACT

+905325920584; actutuncu@gmail.com

Demet Laflı Tunay, Dr.

CONTACT

+905358685831; dlafli@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: October 15, 2023
• Primary Completion: December 15, 2024
• Study Completion: March 31, 2025
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)