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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04694599
Enrollment
94
Registered
2021-01-05
Start date
2021-02-01
Completion date
2021-07-01
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Respiratory Complication

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.

Interventions

Low flow oxygen delivered via nasal prong or facial mask. The flow rate is adjusted according to oxygen saturation of the patient.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The prevalence of prolonged hypoxemic episodes24 hours after transfer to surgical wardthe prevalence of hypoxia lasting more than 1 hour, according to a threshold of SpO2\<90%

Countries

South Korea

Contacts

Primary ContactJaehun Lee, MD
hoon147852@gmail.com+821022857835
Backup ContactHyung-Chul Lee, MD, PhD
vital@snu.ac.kr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026