Identification of Oxygen Desaturation in Patients Admitted Following Adenotonsillectomy'

NCT06512285 | Completed

• 1 other identifier: H-53724
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Continuous pulse oximetry following adenotonsillectomy

  Use of a continuous capture pulse oximeter to identify oxygen desaturations postoperatively

  1 day

Study Arms (1)

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

Interventions

Continuous Pulse Oximetry DIAGNOSTIC_TEST

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

Adenotonsillectomy patients

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Childrens Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• adam adler, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: July 25, 2024
• Primary Completion: May 25, 2025
• Study Completion: May 27, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Locations

US (1)