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

Primary Purpose

Postoperative Respiratory Complication

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Low flow oxygen
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Respiratory Complication

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early intervention

Typical

Arm Description

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

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

Outcomes

Primary Outcome Measures

The prevalence of prolonged hypoxemic episodes
the prevalence of hypoxia lasting more than 1 hour, according to a threshold of SpO2<90%

Secondary Outcome Measures

Full Information

First Posted
January 3, 2021
Last Updated
January 3, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04694599
Brief Title
The Effect of Continuous Pulse Oximetry Monitoring and Early Intervention Using Wearable Device on the Incidence of Postoperative Hypoxemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Respiratory Complication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early intervention
Arm Type
Experimental
Arm Description
The experimental group will receive oxygen supplementation when oxygen saturation decreases according to the monitoring of wearable devices.
Arm Title
Typical
Arm Type
Active Comparator
Arm Description
The control group will receive oxygen supplementation when oxygen saturation decreases according to typical periodical monitoring.
Intervention Type
Device
Intervention Name(s)
Low flow oxygen
Intervention Description
Low flow oxygen delivered via nasal prong or facial mask. The flow rate is adjusted according to oxygen saturation of the patient.
Primary Outcome Measure Information:
Title
The prevalence of prolonged hypoxemic episodes
Description
the prevalence of hypoxia lasting more than 1 hour, according to a threshold of SpO2<90%
Time Frame
24 hours after transfer to surgical ward

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaehun Lee, MD
Phone
+821022857835
Email
hoon147852@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hyung-Chul Lee, MD, PhD
Email
vital@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26287299
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):709-715. doi: 10.1213/ANE.0000000000000836.
Results Reference
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PubMed Identifier
30827008
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.
Results Reference
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PubMed Identifier
28520718
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.
Results Reference
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PubMed Identifier
32519972
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.
Results Reference
background
PubMed Identifier
31743149
Citation
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.
Results Reference
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The Effect of Continuous Pulse Oximetry Monitoring and Early Intervention Using Wearable Device on the Incidence of Postoperative Hypoxemia

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