Obstructive Sleep ApneaNCT06041750
Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients
An observational study of Obstructive Sleep Apnea and Postoperative Complications, run by Cukurova University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea, Postoperative Complications
- What is being tested?
- Elective surgical procedure under general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 31 Mar 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age: 18-65 years
- ASA physical status I-III
- Preoperative OSAS diagnosis (with polysomnography or STOP-BANG questionnaire score)
- Surgeries performed under general anesthesia
- Endotracheal intubation facilitated by neuromuscular blockers
Who cannot join
- ASA physical status IV or V
- Planned admission to the ICU after surgery
- Cardiac Surgery
- Non-operating room anesthesia
- Neuromuscular disease
- Emergency or re-operational procedure
Show all 11Show fewer
- Laryngectomy
- Pneumonectomy
- Invasive airway access
- Pregnancy
- Outpatient surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients; Multicentre, Prospective, Observational Cohort Study
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.
- Being tested
- Elective surgical procedure under general anesthesia
- Keywords
- obstructive sleep apnea, postoperative pulmonary complications, general anesthesia
- Medical subject headings
- Sleep Apnea, Obstructive, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective surgical procedure under general anesthesiaProcedure or surgery
The incidence of postoperative pulmonary complications in OSAS patients undergoing elective surgery under general anesthesia will be determined.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Elective surgical procedure under general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Postoperative day 1, 2, 7 and 30.
Secondary outcomes (4)
Predictive factors
Determination of patient, anesthesia and surgery-related predictive factors affecting the development of postoperative pulmonary complications.
Measured: Postoperative day 1, 2, 7 and 30.
Non-invasive/invasive mechanical ventilation requirement
Determination of the need for non-invasive or invasive mechanical ventilation beyond clinical standards.
Measured: Postoperative day 1, 2, 7 and 30.
Intensive care unit admission
Intensive care unit admission for respiratory indication
Measured: Postoperative day 1, 2, 7 and 30.
Mortality
Mortality rate
Measured: Postoperative day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start15 Oct 2023 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Acibadem University, Baskent University, Manisa Celal Bayar University
- Responsible party
- Principal investigator, Demet Laflı Tunay, Cukurova University
- Investigators
- Çiğdem Tütüncü, Prof. Dr., Study director, İstanbul University, Cerrahpaşa, Faculty of MedicineDemet Laflı Tunay, Dr., Principal investigator, Çukurova University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041750
- Sponsor's protocol ID
- POPCSA
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients; Multicentre, Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06041750
- Acronym / sponsor ID
- POPCSA
- Keywords
- obstructive sleep apnea, postoperative pulmonary complications, general anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Acibadem University, Baskent University, Manisa Celal Bayar University
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSAS patients with postoperative pulmonary complication | – | Procedure: Elective surgical procedure under general anesthesiaAmerican 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Age: 18-65 years
- ASA physical status I-III
- Preoperative OSAS diagnosis (with polysomnography or STOP-BANG questionnaire score)
- Surgeries performed under general anesthesia
- Endotracheal intubation facilitated by neuromuscular blockers
Key exclusion criteria (11 listed)
- ASA physical status IV or V
- Planned admission to the ICU after surgery
- Cardiac Surgery
- Non-operating room anesthesia
- Neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective surgical procedure under general anesthesiaThe incidence of postoperative pulmonary complications in OSAS patients undergoing elective surgery under general anesthesia will be determined. | Procedure or surgery | OSAS patients with postoperative pulmonary complication |
Primary outcome
postoperative pulmonary complications
Time frame: 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
4 secondary outcomes
Predictive factors
Time frame: Postoperative day 1, 2, 7 and 30.
Non-invasive/invasive mechanical ventilation requirement
Time frame: Postoperative day 1, 2, 7 and 30.
Intensive care unit admission
Time frame: Postoperative day 1, 2, 7 and 30.
Mortality
Time frame: Postoperative day 30.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Çiğdem Tütüncü, Prof. Dr. study director
İstanbul University, Cerrahpaşa, Faculty of Medicine
Demet Laflı Tunay, Dr. principal investigator
Çukurova University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Postoperative Complications, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Çiğdem Tütüncü, Prof. Dr. (+905325920584, actutuncu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pulmonary complications (time frame: Postoperative day 1, 2, 7 and 30.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.