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Clinical Trials/NCT04694599
NCT04694599
Unknown
Not Applicable

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

Seoul National University Hospital1 site in 1 country94 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Respiratory Complication
Sponsor
Seoul National University Hospital
Enrollment
94
Locations
1
Primary Endpoint
The prevalence of prolonged hypoxemic episodes
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
July 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

The prevalence of prolonged hypoxemic episodes

Time Frame: 24 hours after transfer to surgical ward

the prevalence of hypoxia lasting more than 1 hour, according to a threshold of SpO2\<90%

Study Sites (1)

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