Recruiting

Pulse Oximeter

Sponsor:

Le Bonheur Children's Hospital

Code:

NCT07686341

Conditions

CHD - Congenital Heart Disease

Single Ventricle Heart Disease

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

vital sign monitoring

Study Details

Brief summary:

The purpose of this study is to find out if an abdominal pulse oximeter device is as accurate as a conventional fingertip pulse oximeter in pediatric patients. In this study, we will be collecting data from your medical record while you are being treated in the hospital for your clinical care. Your baby will be in the study for 3 days. There will be no additional study visits. We will collect information already being obtained while your baby is at the hospital.

Conditions

CHD - Congenital Heart Disease

Single Ventricle Heart Disease

Study ID

NCT07686341

Start date

Aug, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 0-12 months of age. (Must be less than 1 year of life for the pulse oximeter portion of the study) Weight greater than 2 Kg at time of study
  • Admitted to an intensive care unit. (Not applicable for outpatient cohort)
  • Arterial line in place as standard of care (Not applicable for outpatient cohort)
  • Informed consent provided by parent or LAR.

Exclusion Criteria:

  • Open Sternum
  • Skin abnormalities at the proposed sensor site (e.g., rash, eczema, wounds, stoma, or infection)
  • Known allergy or sensitivity to adhesives or materials used in the sensor
  • Excessive movement or irritability that precludes safe and effective placement of the sensor
  • Parent or legal guardian unable to provide informed consent

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

vital sign monitoring

The intervention will be to evaluate abdominal SpO2 against both traditional fingertip readings and gold standard SaO2 measurements by collecting routine data from the medical chart that was performed as standard of care.

Primary outcome measure

  • Abdominal SpO2 versus SaO2 [ Time Frame: From enrollment to end of study at 72 hours. ]

Central Contacts and Locations

Locations

Le Bonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Kara RN

901-287-4594Kara.lessel@mlh.org

More Information

Sponsor

Le Bonheur Children's Hospital

Last update posted

Jul 7, 2026

Last verified

Jun, 2026

Keywords

  • monitoring device
  • pediatric chd
  • single ventricle
  • svhd

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Le Bonheur Children's Hospital on 2026-07-07.