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

NCT04574908 | Completed Results FDA Device

• 1 other identifier: IRB00063530
• Study Type: interventional
• Target: 879
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodynamic Instability; Respiratory Complications of Care

Keywords

postoperative care; postoperative monitoring; vital signs; portable monitor

Outcome Measures

Primary Outcomes (3)

• Duration of Hypotension in Minutes

  Hypotension defined as MAP \<65 mmHg.

  Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)

• Duration of Tachycardia in Minutes

  Tachycardia defined as \>110 beats/min.

  Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)

• Duration of Hypoxemia (SpO2 < 90%) in Minutes

  Duration of Hypoxemia defined as SpO2 \< 90% in Minutes

  Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)

Secondary Outcomes (1)

• Clinical Nursing Intervention Responses Scale

  Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)

Other Outcomes (3)

• Incidence of Myocardial Injury After Non-Cardiac Surgery (MINS)

  Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)

• Patient Satisfaction Survey

  Ward discharge on 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)

• ViSi Monitor Nursing Staff Survey

  After discharge over a period of 7 days

Study Arms (2)

Blinded Ward

ACTIVE COMPARATOR

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.

Device: ViSi device

Unblinded Ward

EXPERIMENTAL

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.

Device: ViSi device

Interventions

ViSi device DEVICE

Mobile patient monitoring system for vital signs.

Blinded Ward; Unblinded Ward

Eligibility Criteria

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

You may qualify if:

• \>/= 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Univesity Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Results Point of Contact

• Title: Portable Hemodynamic Monitoring on Hosp Units
• Organization: Wake Forest University Health Sciences

akhanna@wakehealth.edu

336.716.4498

Study Officials

• Ashish Khanna, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: October 7, 2020
• Primary Completion: October 6, 2021
• Study Completion: October 8, 2021
• Last Updated: May 21, 2024
• Results First Posted: November 22, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: immediately following publication. No end date available.
• Access Criteria: any purpose

Locations

US (1)