Continuous Versus Intermittent Ward Monitoring

ConditionSurgery

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorThe University of Texas Health Science Center, Houston

About this trial

The investigators will randomize adults having major non-cardiac inpatient surgery to blinded versus unblinded continuous postoperative vital sign monitoring (saturation, ventilation, and heart rate). The investigators will use a wearable, untethered, and battery-powered sensor (Masimo Radius PPG, Masimo, Irvine, CA) that wirelessly connects to a Masimo monitor and continuously records saturation, ventilation, and pulse rate.

The primary outcome will be areas-exceeding-thresholds for desaturation (\<85%), bradypnea (\<7 breaths/min), tachypnea (\>30 breaths/min), tachycardia (heart rate \>130 beats/min), and bradycardia (heart rate \<45 beats/min). These exposure thresholds represent a balance between events that are clinically meaningful and excessive alarms that will discourage clinician participation. The investigators expect about 1 alert per patient per day with these thresholds, with most being considered informative or actionable by nurses. In unblinded patients, clinician alerts will be activated at these thresholds.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are admitted to one of the wards equipped with the Masimo Radius PPG and Rad-97 monitors;

Are ≥18 years old;

Are designated American Society of Anesthesiologists physical status 1-4;

Had major noncardiac surgery lasting at least 1.5 hours;

Disqualifiers

Have language, vision, or hearing impairments that may compromise continuous monitoring;

Are designated Do Not Resuscitate, hospice, or receiving end of life care;

Have previously participated in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

Blinded continuous vital sign monitoring
Device
Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
Unblinded continuous vital sign monitoring
Device
Continuous ward monitoring with vital signs available to clinicians and investigators.

Treatment groups

492 Participants

are divided into 2 treatment groups

Group A: Blinded continuous vital sign monitoringSham comparator 1 intervention

Group B: Unblinded continuous vital sign monitoringExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Areas-exceeding-thresholds for desaturation (<85%),4 bradypnea (<7 breaths/min), tachypnea (>30 breaths/min), tachycardia (heart rate >130 beats/min), and bradycardia (heart rate <45 beats/min).

Area of vital sign abnormalities exceeding defined thresholds.

Time frame

48 postoperative hours

Secondary outcomes

Interventions

The incidence of a composite of clinical interventions for desaturation, hypoventilation, tachypnea, tachycardia, bradycardia, and hypotension within 48 hours after major non-cardiac surgery.

Time frame

48 postoperative hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Masimo Corporation

Collaborator

Source ClinicalTrials.gov

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