Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients

NCT ID: NCT06041750

Last Updated: 2023-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-15

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Elective surgical procedure under general anesthesia

Intervention Type PROCEDURE

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

Interventions

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Elective surgical procedure under general anesthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

Acibadem University

OTHER

Sponsor Role collaborator

Baskent University

OTHER

Sponsor Role collaborator

Celal Bayar University

OTHER

Sponsor Role collaborator

Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Demet Laflı Tunay

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Çiğdem Tütüncü, Prof. Dr.

Role: STUDY_DIRECTOR

İstanbul University, Cerrahpaşa, Faculty of Medicine

Demet Laflı Tunay, Dr.

Role: PRINCIPAL_INVESTIGATOR

Çukurova University, Faculty of Medicine

Locations

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Cukurova University

Adana, Sariçam, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Çiğdem Tütüncü, Prof. Dr.

Role: CONTACT

+905325920584

Demet Laflı Tunay, Dr.

Role: CONTACT

+905358685831

Other Identifiers

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POPCSA

Identifier Type: -

Identifier Source: org_study_id

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