A Pilot Trial of Continuous Portable Postoperative Hemodynamic And Saturation Monitoring On Hospital Wards

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

879 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-07

Study Completion Date

2021-10-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study team will collect data for this study from participants who are having surgery and recovering postoperatively on 2 pre-designated hospital units. The study team will use vital signs data from a portable device that participants wear on their wrists as well as conventional vital signs data that is collected when a health care provider comes into their room and collect this information.

A substudy is also being performed with the distribution of surveys to the nursing staff on the floors who are utilizing the ViSi hemodynamic monitors within our institution.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility of a New Ambulatory Multi-vital Signs Monitor

NCT05562011

Perioperative/Postoperative Complications

TERMINATED NA

Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization

NCT05378139

Surgical Complication Pulmonary Disease Hematologic Diseases +3 more

RECRUITING

WARD-Home - Continuous Monitoring of Vital Parameters After Discharge

NCT05223504

Vital Sign Clinical Deterioration

COMPLETED

Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor

NCT05905536

Cardiac Output, Low Stroke Volume

COMPLETED NA

Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical Admission

NCT05536206

Vital Sign Monitoring Clinical Deterioration Disease Progression +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This proposed study will provide the necessary preliminary data for a National Institutes of Health Research Grant Project (NIH R01) application that will test the utility of continuous portable hemodynamic monitoring in a large-scale randomized trial. Two separate post surgical hospital units will be randomized to utilize the Sotera ViSi monitoring system or to not utilize the Sotera ViSi monitoring system for a 4 week period of time alternating over the period of 1 year. The study team will assess the effect of unblinded continuous monitoring and the associated alerts on the cumulative duration (min/hour) of each of hypotension, tachycardia, and desaturation. The study team will assess the effect of continuous monitoring and associated alerts on the ordinal clinical intervention outcome which measures the single most extreme/elevated clinical intervention incurred by a patient for any of the 3 outcome variables of interest (hypotension, tachycardia, hypoxia) during the study period with response by staff. The study team will assess the treatment effect on myocardial injury after non-cardiac surgery (MINS) during the study period.

A substudy involving the the medical center nursing staffs' impressions of the device as well as their confidence in its utilization in keeping their assigned patient's safe will be assessed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodynamic Instability Respiratory Complications of Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The 2 wards will alternate every 4 weeks as to blinded/unblinded allocations. Blinded will be continuous ward monitoring with alarms silenced and screens covered; unblinded will be continuous monitoring accessible to clinicians with pre-specified alerts at MAP \<65 mmHg, heart rate \>110 b/m, and SpO2 \<90%. Of note, to ensure patient safety and no risk in either arm, factory alarm limits (see table under human subjects protection) at extremes of physiological vital signs will stay on in the blinded/silenced arm, and both arms will have every 4 hourly checks by nursing teams.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Blinded Ward

Continuous ward monitoring with hallway monitor screens covered. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered.Continuous monitoring accessible to clinicians with pre-specified alerts at Systolic Blood Pressure alert \<70, no Mean Arterial Pressure alert, heart rate \>150 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) \<80%. Every 4 hourly checks by nursing teams unless otherwise ordered. These alarms are consistent with current standard of care.

Group Type ACTIVE_COMPARATOR

ViSi device

Intervention Type DEVICE

Mobile patient monitoring system for vital signs.

Unblinded Ward

Continuous ward monitoring with hallway monitor screens accessible for viewing but with alarm limits more narrow. When an alarm goes off (limits based on the stratification of that month) the nursing staff will still be notified via their Ascom phone as per standard of care. Nursing staff will be able to view the hallway monitors showing the vital signs in all of the rooms and/or log in to WakeOne to verify the vital sign and/or go to the patient room to check on the patient. To ensure patient safety, factory alarm limits at extremes of physiological vital signs will stay on in the blinded arm. Every 4 hourly checks by nursing teams unless otherwise ordered. Continuous monitoring accessible to clinicians with pre-specified alerts at Mean Arterial Pressure (MAP) \<65 mmHg, heart rate \>110 beats per minute (b/m), and peripheral capillary oxygen saturation (SpO2) \<90%. Every 4 hourly checks by nursing teams unless otherwise ordered.

Group Type EXPERIMENTAL

ViSi device

Intervention Type DEVICE

Mobile patient monitoring system for vital signs.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ViSi device

Mobile patient monitoring system for vital signs.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \>/= 65 years of age
* \>/= 45 years of age with at least 1 cardiovascular risk (hypertension, diabetes)
* Requiring a general or regional anesthetic as part of their surgical procedure.
* Requiring (or anticipated to require) at least a 48 hour hospital stay after surgery.
* All subjects aged 18 and older who are patients receiving ViSi monitoring on the 2 nursing units involved.

Exclusion Criteria

* \< 48 hour hospital stay
* Receiving local anesthetic for their surgical procedure
* troponins not ordered if \<65 years of age without a single cardiovascular risk factor or \<45 years of age

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No