Clinical trial NCT04694599: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Respiratory Complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 94
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The prevalence of prolonged hypoxemic episodes
timeFrame: 24 hours after transfer to surgical ward
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
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.
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.
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.
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.
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.