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Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Pediatric Cardiac Surgery

Treatments

Device: Masimo O3

Study type

Interventional

Funder types

Other

Identifiers

NCT04208906
H1911-099-1081

Details and patient eligibility

About

We evaluate the relationship between the regional tissue oxygenation value (ScO2 - cerebral, StO2 - lower limb) and mixed venous saturation (SvO2) and arterial oxygen saturation (SaO2) measured before and after correction surgery in pediatric patients undergoing cardiac surgery.

In addition, we compared the sCO2 and sTO2 with reference value which is calculated using SvO2 and SaO2.

Enrollment

50 patients

Sex

All

Ages

Under 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • children under 7 years old

Exclusion criteria

  • Hyperbilirubinemia
  • Skin disease at sensor attachment site
  • Single ventricle physiology

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Children with congenital cardiac disease
Experimental group
Description:
Pediatric patients aged \< 7 years undergoing cardiac surgery
Treatment:
Device: Masimo O3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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