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| Name | Class |
|---|---|
| Istanbul University - Cerrahpasa | OTHER |
| Acibadem University | OTHER |
| Baskent University | OTHER |
| Manisa Celal Bayar University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Non-invasive/invasive mechanical ventilation requirement |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Çiğdem Tütüncü, Prof. Dr. | Contact | +905325920584 | actutuncu@gmail.com | |
| Demet Laflı Tunay, Dr. | Contact | +905358685831 | dlafli@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Çiğdem Tütüncü, Prof. Dr. | İstanbul University, Cerrahpaşa, Faculty of Medicine | Study Director |
| Demet Laflı Tunay, Dr. | Çukurova University, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cukurova University | Adana | Sariçam | 01100 | Turkey (Türkiye) |
All data will be anonymized by the local researcher. Therefore, data collection will be pseudonymous and the patient's name will not appear on any case report form or other study document. All collected data will be kept confidential. This study will be conducted in accordance with the revision of the Declaration of Helsinki (2008). ICH-GCP will be strictly adhered to.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| OTHER |
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Determination of the need for non-invasive or invasive mechanical ventilation beyond clinical standards. |
| Postoperative day 1, 2, 7 and 30. |
| Intensive care unit admission | Intensive care unit admission for respiratory indication | Postoperative day 1, 2, 7 and 30. |
| Mortality | Mortality rate | Postoperative day 30. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |