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

NCT04694599 | Unknown FDA Device

• 1 other identifier: RadiusPPG
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Respiratory Complication

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Early intervention

EXPERIMENTAL

The experimental group will receive oxygen supplementation when oxygen saturation decreases according to the monitoring of wearable devices.

Device: Low flow oxygen

Typical

ACTIVE COMPARATOR

The control group will receive oxygen supplementation when oxygen saturation decreases according to typical periodical monitoring.

Device: Low flow oxygen

Interventions

Low flow oxygen DEVICE

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

Early intervention; Typical

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (5)

• 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):709-715. doi: 10.1213/ANE.0000000000000836.

  PMID: 26287299 BACKGROUND

• 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.

  PMID: 30827008 BACKGROUND

• 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.

  PMID: 28520718 BACKGROUND

• 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.

  PMID: 32519972 BACKGROUND

• 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.

  PMID: 31743149 BACKGROUND

Central Study Contacts

Jaehun Lee, MD

CONTACT

+821022857835; hoon147852@gmail.com

Hyung-Chul Lee, MD, PhD

CONTACT

vital@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 5, 2021
• Study Start: February 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)