Diaphragm Ultrasound İn Children With OSAS
ConditionObstructive Sleep Apnea of Child
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-12
SponsorIstanbul University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Obstructive Sleep Apnea Group
Group B: Control Group
Trial outcomes
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.
Time frame
Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.Secondary outcomes
1
Diaphragmatic Thickness at End-Inspiration (mm)
Diaphragmatic thickness at end-inspiration will be measured by ultrasonography. Values will be compared between the OSAS group and the control group, as well as between preoperative and postoperative measurements.
Time frame
Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.2
Perioperative Respiratory and Recovery Parameters
Perioperative respiratory and recovery parameters will be recorded, including oxygen saturation (SpO₂), end-tidal carbon dioxide (EtCO₂) values, Aldrete scores at recovery room admission and discharge, and length of stay in the recovery room. These parameters will be evaluated for associations with diaphragmatic ultrasonography measures and study group (OSAS vs control).
Time frame
During surgery and for the duration of postoperative recovery.3
Diaphragmatic Thickness at End-Expiration (mm)
Diaphragmatic thickness at end-expiration will be measured by ultrasonography. Values will be compared between the OSAS group and the control group, as well as between preoperative and postoperative measurements
Time frame
Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.4
Diaphragmatic Excursion During Quiet Breathing (mm)
Craniocaudal diaphragmatic excursion during quiet tidal breathing will be measured by M-mode ultrasonography. Values will be compared between the OSAS group and the control group, as well as between preoperative and postoperative measurements.
Time frame
Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.Sponsors and contacts
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Source ClinicalTrials.gov