Identification of Oxygen Desaturation in Patients Admitted Following Adenotonsillectomy'

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT06512285
• Lead Sponsor: Baylor College of Medicine

Brief Summary

Sleep apnea has become exceedingly recognized in children. The primary treatment for sleep apnea in children is surgery in the form of adenotonsillectomy. The majority of children that undergo adenotonsillectomy are discharged following their immediate recovery in the post anesthesia care unit.

Detailed Description

Based on national and international consensus statements, institutional practice has developed at Texas Children's Hospital as to which patients require overnight observation following adenotonsillectomy for continuous pulse oximeter monitoring to assess for desaturation events. There is insufficient evidence to suggest which patients need to stay for pulse oximeter monitoring which has led to many patients being admitted unnecessarily. Therefore, the aim of this study is to capture data prospectively on pulse oximetry in children admitted overnight following adenotonsillectomy to identify risk factors for post operative oxygen desaturation.

Study Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Study Start: 2024-07-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Adenotonsillectomy surgery
• Patient meeting institutional guidelines for postoperative admission (e.g, admitted following surgery from recovery room).

Exclusion Criteria

• Parental refusal
• Airway Surgery in addition to adenotonsillectomy
• Patient psychological limitations, precluding wearing device (e.g. autism).
• Patient not meeting institutional guidelines for postoperative admission (e.g, discharged following surgery from recovery room).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Continuous pulse oximetry following adenotonsillectomy	1 day	Use of a continuous capture pulse oximeter to identify oxygen desaturations postoperatively

Trial Locations

Locations (1)

Texas Childrens Hospital; 🇺🇸 Houston, Texas, United States