Diaphragm Ultrasound İn Children With OSAS

NCT07380321 | Recruiting

• 1 other identifier: 2024/2005
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Child

Keywords

Pediatric Sleep Questionnaire; diaphragm ultrasound; adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

• Diaphragmatic Thickening Fraction (%)

  Diaphragmatic thickening fraction will be calculated as (thickness at end-inspiration - thickness at end-expiration) / thickness at end-expiration × 100%, measured by ultrasound. The primary comparison will be between the OSAS group and the control group. Measurements will be assessed before and after surgery.

  Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.

Secondary Outcomes (6)

• Diaphragmatic Thickness at End-Inspiration (mm)

  Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.

• Perioperative Respiratory and Recovery Parameters

  During surgery and for the duration of postoperative recovery.

• Diaphragmatic Thickness at End-Expiration (mm)

  Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.

• Diaphragmatic Excursion During Quiet Breathing (mm)

  Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.

• Diaphragmatic Excursion During Deep Breathing (mm)

  Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.

Study Arms (2)

Obstructive Sleep Apnea Group

Children with obstructive sleep apnea syndrome, defined by at least 8 "yes" responses out of 22 items on the Pediatric Sleep Questionnaire (PSQ), scheduled for adenotonsillectomy under general anesthesia.

Control Group

Children without obstructive sleep apnea, defined by fewer than 8 "yes" responses out of 22 items on the Pediatric Sleep Questionnaire (PSQ), scheduled for elective non-airway-related otolaryngologic surgeries under general anesthesia.

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 1-12 years who are followed at the Department of Otolaryngology of Istanbul University Istanbul Faculty of Medicine and are scheduled for surgery will be included in this study. Participants will be assessed preoperatively using the Pediatric Sleep Questionnaire (PSQ). Children who answer "yes" to at least 8 of the 22 items and are scheduled to undergo adenotonsillectomy will be assigned to the obstructive sleep apnea syndrome (OSAS) group, whereas children who answer "yes" to fewer than 8 items and are scheduled to undergo elective non-airway-related otolaryngologic surgery will be included in the control group. Only children with ASA physical status I-II who meet the inclusion and exclusion criteria and for whom informed consent has been obtained will be enrolled.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Study Officials

• Furkan Kelebek, Resident

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Demet Altun, Professor

  Istanbul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Demet Altun, Professor

CONTACT

00905326811767; drdemetaltun@hotmail.com

Furkan Kelebek, Resident

CONTACT

00905426140993; furkan.kelebek@istanbul.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: February 2, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

TU (1)