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Completed

NCT Number: NCT04574908

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

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.

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Key information

Conditions

Hemodynamic Instability Respiratory Complications of Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Univesity Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ViSi device

Device

Mobile patient monitoring system for vital signs.

Primary outcomes

  1. Duration of Hypotension in Minutes

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

    Hypotension defined as MAP <65 mmHg.

  2. Duration of Tachycardia in Minutes

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

    Tachycardia defined as >110 beats/min.

  3. Duration of Hypoxemia (SpO2 < 90%) in Minutes

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

    Duration of Hypoxemia defined as SpO2 < 90% in Minutes

Secondary outcomes

  1. Clinical Nursing Intervention Responses Scale

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

    Clinical nursing intervention responses over the duration of the trial will be categorized as (1) none, (2) independent nursing intervention, (3) notification of physician team, or (4) activation of the hospital Emergency or Rapid Response System. Scale ranges from 1-4 with 4 denoting a worse outcome.

Other outcomes

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

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

    Determined by blood troponin levels. Concentrations ≥0.03 ng/ml will be considered MINS if there is no evidence of a non-ischemic etiology.

  2. Patient Satisfaction Survey

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

    Score ranges from 5-50 with higher score denoting better outcome.

  3. ViSi Monitor Nursing Staff Survey

    Time frame: After discharge over a period of 7 days

    Survey showing the nursing perceptions of Certification for Neurophysiological Intraoperative Monitoring (CNIM) as well as the value of these devices in the care of their patients. Survey will obtain impressions of device from nurses. And descriptive statistics will be obtained regarding nurse's impressions of this technology after its having been implemented. Data will be reported via percentages the responses received.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2020
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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