Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients

• Sponsor: Cukurova University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06041750
• Collaborator: Istanbul University - Cerrahpasa (IUC) (Other), Acibadem University (Other), Baskent University (Other), Celal Bayar University (Other)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 17.5
• Patients Per Site Per Month: 28.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea; Postoperative Complications	Procedure: Elective surgical procedure under general anesthesia

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Predicting Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients; Multicentre, Prospective, Observational Cohort Study
• Anticipated Study Start Date: Oct 15, 2023
• Anticipated Primary Completion Date: Dec 15, 2024
• Anticipated Study Completion Date: Mar 31, 2025

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. Intensive care unit admission [Postoperative day 1, 2, 7 and 30.]

   Intensive care unit admission for respiratory indication

4. Mortality [Postoperative day 30.]

   Mortality rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cukurova University	Adana	Sariçam	Turkey	01100

Sponsors and Collaborators

• Cukurova University
• Istanbul University - Cerrahpasa (IUC)
• Acibadem University
• Baskent University
• Celal Bayar University

Investigators

• Study Director: Çiğdem Tütüncü, Prof. Dr., İstanbul University, Cerrahpaşa, Faculty of Medicine
• Principal Investigator: Demet Laflı Tunay, Dr., Çukurova University, Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Demet Laflı Tunay, Assistant Professor, Cukurova University
• ClinicalTrials.gov Identifier: NCT06041750
• Other Study ID Numbers: POPCSA
• First Posted: Sep 18, 2023
• Last Update Posted: Sep 18, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Demet Laflı Tunay, Assistant Professor, Cukurova University: obstructive sleep apnea; postoperative pulmonary complications; general anesthesia
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Postoperative Complications; Anesthetics

Study Results

No Results Posted as of Sep 18, 2023