Identification of Oxygen Desaturation in Patients Admitted Following Adenotonsillectomy'

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Diagnostic test: Continuous Pulse Oximetry

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 Type: Observational
• Enrollment (Actual): 178

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing adenotonsilectomy at Texas Children's Hospital Main campus that meet institutional requirements for post-operative admission for continuous pulse oximetry monitoring

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adenotonsillectomy patients; Patients having undergone adenotonsillectomy at Texas Children's Hospital admitted for overnight observation based on our institutional protocol will be enrolled. A Wrist OX 3150 (Nonin Medical) will be placed in PACU with saturations recorded until the following morning after the surgery. The patient will undergo pulse oximetry monitoring separately based on the hospital protocol that will be used to guide care. Data from the Wrist Ox will not be avail to the treatment team and will only be analyzed for research purposes.

Diagnostic test: Continuous Pulse Oximetry; The patient will wear a continuous pulse oximeter after their adenotonsillectomy surgery until the following morning. This will record continuous pulse oximetry data to allow for analysis of any desaturations in the first night following the surgery. This study is observational only and this data will not be used to impact any treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous pulse oximetry following adenotonsillectomy	Use of a continuous capture pulse oximeter to identify oxygen desaturations postoperatively	1 day

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: adam adler, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Actual): May 25, 2025
• Study Completion (Actual): May 27, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: H-53724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deidentified data will be shared on reasonable written request to the PI. in accordance with institutional policies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No