NCT07380321 Diaphragm Ultrasound İn Children With OSAS
| NCT ID | NCT07380321 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University |
| Condition | Obstructive Sleep Apnea of Child |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-09-01 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective observational study evaluating perioperative diaphragmatic function by ultrasonography in children aged 1-12 years undergoing elective surgery under general anesthesia. Participants will be classified preoperatively based on the parent-completed Pediatric Sleep Questionnaire (PSQ). Children with suspected obstructive sleep apnea syndrome who are scheduled for adenotonsillectomy will form the study group, while children without clinical findings suggestive of obstructive sleep apnea who are scheduled for elective non-airway-related otolaryngologic surgeries will serve as controls. Diaphragm ultrasound assessments will be performed before and after surgery in the supine position during spontaneous breathing. Measurements will include diaphragmatic thickness at end-inspiration and end-expiration, diaphragmatic thickening fraction, and diaphragmatic excursion during quiet and deep breathing. The primary objective is to compare diaphragmatic excursion and thickening fraction between groups. Secondary objectives include evaluating the association between perioperative respiratory parameters, postoperative recovery, and diaphragm ultrasound measures.
Eligibility Criteria
Inclusion Criteria: * ASA physical status I-II * Children aged 1 to 12 years * Scheduled to undergo elective surgery under general anesthesia * Written informed consent obtained from parents or legal guardians * Availability of a completed pediatric sleep questionnaire (PSQ) Exclusion Criteria: * Patients younger than 1 year or older than 12 years * Presence of a neuromuscular disease * Use of medications that may affect neuromuscular function * Diaphragmatic paralysis * ASA physical status III-IV * Refusal to participate in the study or failure to provide informed consent * Body mass index (BMI) \> 35 kg/m²
Contact & Investigator
Furkan Kelebek, Resident
PRINCIPAL INVESTIGATOR
Istanbul University
Frequently Asked Questions
Who can join the NCT07380321 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 12 Years, studying Obstructive Sleep Apnea of Child. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07380321 currently recruiting?
Yes, NCT07380321 is actively recruiting participants. Contact the research team at drdemetaltun@hotmail.com for enrollment information.
Where is the NCT07380321 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07380321 clinical trial?
NCT07380321 is sponsored by Istanbul University. The principal investigator is Furkan Kelebek, Resident at Istanbul University. The trial plans to enroll 60 participants.