Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06041750
• Other study ID #: POPCSA
• Status: Not yet recruiting
• Start date: October 15, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: September 2023
• Source: Cukurova University
• Contact: Çigdem Tütüncü, Prof. Dr.
• Phone: +905325920584
• Email: actutuncu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: March 31, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Postoperative Complications
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana	Sariçam

Sponsors (5)

Lead Sponsor	Collaborator
Cukurova University	Acibadem University, Baskent University, Celal Bayar University, Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Intensive care unit admission	Intensive care unit admission for respiratory indication	Postoperative day 1, 2, 7 and 30.
Secondary	Mortality	Mortality rate	Postoperative day 30.