Istanbul University, Department of Anesthesiology
Istanbul, Fatih, 34093, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07380321
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.
Interested in participating?
Request Info1 year–12 year
All sexes
Observational
Istanbul, Fatih, 34093, Turkey (Türkiye)
Location status: Recruiting
This prospective observational study is designed to evaluate perioperative diaphragmatic function using ultrasonography in pediatric patients undergoing elective surgery under general anesthesia. The study will be conducted in 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 based on clinical indications.
A total of 60 children will be enrolled in the study in accordance with predefined inclusion and exclusion criteria. Participants will be classified into two groups based on the results of the parent-completed Pediatric Sleep Questionnaire (PSQ) administered preoperatively. A PSQ total score of ≥0.33 (at least 8 "yes" responses out of 22 items) will be considered indicative of suspected obstructive sleep apnea, and children scheduled for adenotonsillectomy will form the study group. Children with a PSQ total score of <0.33 and no clinical findings suggestive of obstructive sleep apnea who are scheduled for elective non-airway-related otolaryngologic surgeries will be included in the control group.
All patients will receive standardized perioperative anesthesia and surgical care. Diaphragmatic ultrasonographic assessments will be performed in the supine position during spontaneous breathing preoperatively and postoperatively. Diaphragmatic thickness will be assessed using a 4-15 MHz linear transducer placed perpendicular to the chest wall at the 7th-9th intercostal space along the right anterior axillary line; thickness will be measured at end-inspiration and end-expiration, and the diaphragmatic thickening fraction will be calculated. Diaphragmatic excursion will be evaluated using a 1-6 MHz convex transducer positioned in the right anterior subcostal region between the midclavicular and anterior axillary lines, and craniocaudal excursion will be recorded during quiet and deep breathing.
The primary objective of this study is to evaluate diaphragmatic function by comparing diaphragmatic thickening fraction between children with suspected obstructive sleep apnea and a control group. Secondary objectives include the assessment of diaphragmatic excursion, the evaluation of associations between diaphragmatic ultrasonography parameters and perioperative respiratory variables, and the assessment of postoperative recovery characteristics. In this context, the study aims to investigate the role of diaphragmatic ultrasonography as a noninvasive perioperative assessment tool for the evaluation of respiratory function and perioperative respiratory findings in children with suspected obstructive sleep apnea undergoing surgery.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
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.
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: During surgery and for the duration of postoperative recovery.
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: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
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.
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.
Craniocaudal diaphragmatic excursion during deep 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.
The ratio of diaphragmatic excursion during quiet breathing to diaphragmatic excursion during deep breathing will be calculated. Values will be compared between the OSAS group and the control group, as well as between preoperative and postoperative measurements.
Contact information is provided by the study sponsor or research team.
Demet Altun, Professor
CONTACT
Furkan Kelebek, Resident
CONTACT
Istanbul University
Other
Perioperative Ultrasonographic Assessment Of Diaphragmatic Function İn Pediatric Obstructive Sleep Apnea
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07345312
Obstructive Sleep Apnea of Child
Nancy, Grand Est, France
View Trial DetailsNCT05115968
Obstructive Sleep Apnea of Child
Hong Kong
View Trial DetailsNCT06634264
Adenotonsillar Hypertrophy, Apnea
Montreal, Quebec, Canada
View Trial DetailsNCT06367400
Apnea, Dyssomnias
Uppsala, Sweden
View Trial Details