Hemodynamic Instability, Respiratory Complications of Care
Conditions
Keywords
postoperative care, postoperative monitoring, vital signs, portable monitor
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.
Detailed description
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.
Interventions
DEVICEViSi device
Mobile patient monitoring system for vital signs.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hypotension in Minutes | Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) | Hypotension defined as MAP \<65 mmHg. |
| Duration of Hypoxemia (SpO2 < 90%) in Minutes | Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) | Duration of Hypoxemia defined as SpO2 \< 90% in Minutes |
| Duration of Tachycardia in Minutes | Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) | Tachycardia defined as \>110 beats/min. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Nursing Intervention Responses Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Myocardial Injury After Non-Cardiac Surgery (MINS) | 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. |
| ViSi Monitor Nursing Staff Survey | 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. |
| Patient Satisfaction Survey | Ward discharge on 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier) | Score ranges from 5-50 with higher score denoting better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
ViSi device: Mobile patient monitoring system for vital signs. | 431 |
| 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.
ViSi device: Mobile patient monitoring system for vital signs. | 448 |
| Total | 879 |
Baseline characteristics
| Characteristic | Unblinded Ward | Total | Blinded Ward |
|---|---|---|---|
| Age, Continuous | 70.65 years | 70.74 years | 71.16 years |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 73 Participants | 141 Participants | 68 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 21 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 360 Participants | 708 Participants | 348 Participants |
| Sex: Female, Male Female | 247 Participants | 483 Participants | 236 Participants |
| Sex: Female, Male Male | 201 Participants | 396 Participants | 195 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 431 | 4 / 448 |
| other Total, other adverse events | 0 / 431 | 0 / 448 |
| serious Total, serious adverse events | 7 / 431 | 4 / 448 |
Outcome results
Primary
Duration of Hypotension in Minutes
Hypotension defined as MAP \<65 mmHg.
Time frame: Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blinded Ward | Duration of Hypotension in Minutes | 0.00 Minutes |
| Unblinded Ward | Duration of Hypotension in Minutes | 0.00 Minutes |
Primary
Duration of Hypoxemia (SpO2 < 90%) in Minutes
Duration of Hypoxemia defined as SpO2 \< 90% in Minutes
Time frame: Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blinded Ward | Duration of Hypoxemia (SpO2 < 90%) in Minutes | 0.04 Minutes |
| Unblinded Ward | Duration of Hypoxemia (SpO2 < 90%) in Minutes | 0.03 Minutes |
Primary
Duration of Tachycardia in Minutes
Tachycardia defined as \>110 beats/min.
Time frame: Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blinded Ward | Duration of Tachycardia in Minutes | 0.01 Minutes |
| Unblinded Ward | Duration of Tachycardia in Minutes | 0.01 Minutes |
Secondary
Clinical Nursing Intervention Responses Scale
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.
Time frame: Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
Population: nurses did not enter timely responses in the EMR and therefore there is no data for that outcome measure.
Other Pre-specified
Incidence of Myocardial Injury After Non-Cardiac Surgery (MINS)
Determined by blood troponin levels. Concentrations ≥0.03 ng/ml will be considered MINS if there is no evidence of a non-ischemic etiology.
Time frame: Ward Admission Ward Admission Through 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Blinded Ward | Incidence of Myocardial Injury After Non-Cardiac Surgery (MINS) | yes | 71 Participants |
| Blinded Ward | Incidence of Myocardial Injury After Non-Cardiac Surgery (MINS) | no | 360 Participants |
| Unblinded Ward | Incidence of Myocardial Injury After Non-Cardiac Surgery (MINS) | yes | 71 Participants |
| Unblinded Ward | Incidence of Myocardial Injury After Non-Cardiac Surgery (MINS) | no | 377 Participants |
Other Pre-specified
Patient Satisfaction Survey
Score ranges from 5-50 with higher score denoting better outcome.
Time frame: Ward discharge on 3rd Postoperative Morning or 48 Continuous Hours (Whichever Comes Earlier)
Population: OM Data not collected
Other Pre-specified
ViSi Monitor Nursing Staff Survey
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.
Time frame: After discharge over a period of 7 days
Population: OM Data not collected