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

Postoperative Respiratory Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04694599
• Other study ID #: RadiusPPG
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: January 2021
• Source: Seoul National University Hospital
• Contact: Jaehun Lee, MD
• Phone: +821022857835
• Email: hoon147852[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: July 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Postoperative Respiratory Complication

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Breteler MJM, KleinJan EJ, Dohmen DAJ, Leenen LPH, van Hillegersberg R, Ruurda JP, van Loon K, Blokhuis TJ, Kalkman CJ. Vital Signs Monitoring with Wearable Sensors in High-risk Surgical Patients: A Clinical Validation Study. Anesthesiology. 2020 Mar;132(3):424-439. doi: 10.1097/ALN.0000000000003029. — View Citation

Ishikawa M, Sakamoto A. Postoperative desaturation and bradypnea after general anesthesia in non-ICU patients: a retrospective evaluation. J Clin Monit Comput. 2020 Feb;34(1):81-87. doi: 10.1007/s10877-019-00293-0. Epub 2019 Mar 2. — View Citation

Ramachandran SK, Thompson A, Pandit JJ, Devine S, Shanks AM. Retrospective observational evaluation of postoperative oxygen saturation levels and associated postoperative respiratory complications and hospital resource utilization. PLoS One. 2017 May 17;12(5):e0175408. doi: 10.1371/journal.pone.0175408. eCollection 2017. — View Citation

Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-15. doi: 10.1213/ANE.0000000000000836. — View Citation

Weenk M, Bredie SJ, Koeneman M, Hesselink G, van Goor H, van de Belt TH. Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial. J Med Internet Res. 2020 Jun 10;22(6):e15471. doi: 10.2196/15471. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of prolonged hypoxemic episodes	the prevalence of hypoxia lasting more than 1 hour, according to a threshold of SpO2<90%	24 hours after transfer to surgical ward