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The Effect of Continuous Pulse Oximetry Monitoring and Early Intervention Using Wearable Device on the Incidence of Postoperative Hypoxemia

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Seoul National University

Status

Unknown

Conditions

Postoperative Respiratory Complication

Treatments

Device: Low flow oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT04694599
RadiusPPG

Details and patient eligibility

About

Vital signs of postoperative patient are monitored intensively in post-anesthesia care unit or intensive care unit, but the frequency of surveillance decreases in typical surgical wards. The continuous pulse oximetry in surgical wards is known to be useful in detection and prevention of hypoxemia, reducing complications caused by postoperative respiratory depression. However, continuous monitoring is not conducted, due to shortage of equipment and personnel. Recently, wearable device for measuring pulse oxygen saturation, which is inexpensive, applicable to patients with mobility, and can be monitored continuously through wireless connection, has been supplied. In this study, the investigators evaluate the effect of continuous monitoring of oxygen saturation with wireless device(MASIMO Radius-7) on postoperative patients who are transferred to general wards, and evaluate the effect of early intervention in reducing the event of hypoxemia.

Enrollment

94 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing noncardiac surgery under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status class I-III

Exclusion criteria

  • Patients refusing to participate in the study
  • Patients under emergency surgery
  • Patients who wearable device is not applicable
  • Patients scheduled to be transferred to intensive care unit
  • Patients scheduled to receive oxygen supplementation in surgical ward
  • Patients scheduled to undergo continuous pulse oximetry monitoring

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

94 participants in 2 patient groups

Early intervention
Experimental group
Description:
The experimental group will receive oxygen supplementation when oxygen saturation decreases according to the monitoring of wearable devices.
Treatment:
Device: Low flow oxygen
Typical
Active Comparator group
Description:
The control group will receive oxygen supplementation when oxygen saturation decreases according to typical periodical monitoring.
Treatment:
Device: Low flow oxygen

Trial contacts and locations

1

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Central trial contact

Jaehun Lee, MD; Hyung-Chul Lee, MD, PhD

Data sourced from clinicaltrials.gov

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