Identification of Oxygen Desaturation in Patients Admitted Following Adenotonsillectomy'

NCT ID: NCT06512285

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 178 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2025-05-27

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Continuous Pulse Oximetry

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Adam Adler MD, MS, FAAP

Associate Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

adam adler, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Childrens Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

H-53724

Identifier Type: -

Identifier Source: org_study_id