Diaphragm ultrasound in children with obstructive sleep apnea
Perioperative Ultrasonographic Assessment Of Diaphragmatic Function İn Pediatric Obstructive Sleep Apnea
Istanbul University · NCT07380321
Doctors will use diaphragm ultrasound to see if children aged 1-12 with suspected obstructive sleep apnea have different diaphragm movement before and after surgery compared with kids having other elective ENT surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 12 Years |
| Sex | All |
| Sponsor | Istanbul University (other) |
| Locations | 1 site (Istanbul, Fatih) |
| Trial ID | NCT07380321 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling 60 children aged 1-12 who are undergoing elective surgery at Istanbul University. Participants are classified by a parent-completed Pediatric Sleep Questionnaire (PSQ ≥0.33 indicates suspected OSAS) into an adenotonsillectomy group and a non-airway otolaryngology control group. Diaphragm ultrasound will be performed in the supine position during spontaneous breathing before and after surgery to measure thickness at end-inspiration and end-expiration, thickening fraction, and diaphragmatic excursion during quiet and deep breathing. All patients will receive standardized perioperative anesthesia and surgical care and measurements will be obtained using appropriate ultrasound transducers.
Who should consider this trial
Good fit: Children aged 1-12 years with ASA physical status I-II who are scheduled for elective adenotonsillectomy and have a PSQ score ≥0.33, with parental consent, are ideal candidates.
Not a fit: Children outside the 1-12 age range, those with neuromuscular disease or diaphragmatic paralysis, ASA III-IV patients, those on medications affecting neuromuscular function, or with BMI >35 kg/m² are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the findings could help identify perioperative diaphragm dysfunction in children with OSAS and guide anesthesia and postoperative respiratory care to reduce complications.
How similar studies have performed: Diaphragm ultrasound is an established technique in adults and has been applied in pediatrics, but perioperative diaphragm measurement specifically in children with OSAS is relatively novel and not extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Istanbul, Fatih
- Istanbul University, Department of Anesthesiology — Istanbul, Fatih, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Furkan Kelebek, Resident — Istanbul University
- Study coordinator: Demet Altun, Professor
- Email: drdemetaltun@hotmail.com
- Phone: 00905326811767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea of Child, Pediatric Sleep Questionnaire, diaphragm ultrasound, adenotonsillectomy