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

Not Applicable

• Conditions: Postoperative Respiratory Complication
• Interventions: Device: Low flow oxygen

• Registration Number: NCT04694599
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-03
• Study First Submitted QC: 2021-01-03
• Last Update Submitted: 2021-01-03
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05
• Study Start: 2021-02-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Typical	Low flow oxygen	The control group will receive oxygen supplementation when oxygen saturation decreases according to typical periodical monitoring.
Early intervention	Low flow oxygen	The experimental group will receive oxygen supplementation when oxygen saturation decreases according to the monitoring of wearable devices.

Primary Outcome Measures

Name	Time	Method
The prevalence of prolonged hypoxemic episodes	24 hours after transfer to surgical ward	the prevalence of hypoxia lasting more than 1 hour, according to a threshold of SpO2\<90%

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of