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Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06041750
Enrollment
500
Registered
2023-09-18
Start date
2023-10-15
Completion date
2025-03-31
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Postoperative Complications

Keywords

obstructive sleep apnea, postoperative pulmonary complications, general anesthesia

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.

Interventions

PROCEDUREElective surgical procedure under general anesthesia

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

Sponsors

Istanbul University - Cerrahpasa
CollaboratorOTHER
Acibadem University
CollaboratorOTHER
Baskent University
CollaboratorOTHER
Celal Bayar University
CollaboratorOTHER
Cukurova University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
postoperative pulmonary complicationsPostoperative 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

MeasureTime frameDescription
Predictive factorsPostoperative day 1, 2, 7 and 30.Determination of patient, anesthesia and surgery-related predictive factors affecting the development of postoperative pulmonary complications.
Non-invasive/invasive mechanical ventilation requirementPostoperative day 1, 2, 7 and 30.Determination of the need for non-invasive or invasive mechanical ventilation beyond clinical standards.
Intensive care unit admissionPostoperative day 1, 2, 7 and 30.Intensive care unit admission for respiratory indication
MortalityPostoperative day 30.Mortality rate

Countries

Turkey (Türkiye)

Contacts

Primary ContactÇiğdem Tütüncü, Prof. Dr.
actutuncu@gmail.com+905325920584
Backup ContactDemet Laflı Tunay, Dr.
dlafli@yahoo.com+905358685831

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026