Surgery
Conditions
Brief summary
The investigators plan a pilot study to evaluate patient tolerance of the GE Portrait Mobile Monitoring Solution, along with appropriate alert thresholds, and clinical utility. Data obtained in the proposed pilot cohort will guide design of a future robust randomized trial comparing clinical interventions and serious complications with blinded versus unblinded continuous ward monitoring.
Detailed description
The investigators plan a pilot study to evaluate patient tolerance of the GE Portrait Mobile Monitoring Solution, along with appropriate alert thresholds, and clinical utility. The system is a novel battery-powered untethered monitor for continuous monitoring of oxygen saturation, respiratory rate, and pulse rate that is designed for use by patients on surgical wards. The initial phase will evaluate patient tolerance, with clinicians and patients blinded to monitor data. Results will be used to evaluate the frequency of respiratory events and pulse rate abnormalities. These data will be used to design clinical alert settings, based on various durations at various thresholds (e.g., saturation \<85% for \>1 minute). Our main goal will be to identify clinically meaningful vital sign abnormalities with a minimum of false alerts. Secondarily, the investigators will evaluate the frequency and duration of abnormalities, and the fraction that are detected clinically. In the second phase of the pilot, clinicians will be unblinded to the GE Portrait monitors, and alerts provided based on the durations and threshold identified in the initial part of the pilot. The primary outcomes will be clinician tolerance and the extent to which clinicians believe that vital sign trending and alerts provided useful information rather than distraction. Specifically, the investigators will assess the fraction of alerts that clinicians deemed meaningful, and the fraction that resulted in clinical interventions. In the third phase of the pilot, the durations and thresholds for saturation, respiratory rate, and pulse rate that trigger alerts will be adjusted based on results from the second phase.
Interventions
DEVICEBlinded GE Portrait Monitoring
Continuous vital signs will be monitored and recorded by GE Portrait but not available to clinicians.
DEVICEUnblinded GE Portrait Monitoring
Continuous vital signs will be monitored and evaluated by clinicians using GE Portrait.
Sponsors
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are admitted to one of the wards equipped with the GE Portrait Mobile Solution. * Are designated American Society of Anesthesiologists physical status 1-4. * Had major noncardiac surgery lasting at least 1.5 hours. * Are expected to remain hospitalized at least two postoperative nights. * Had general anesthesia with or without neuraxial anesthesia.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2- Cumulative Duration of Vital Sign Abnormalities | Up to 72 hours after surgery | The vital sign abnormalities is a 5-component composite including the durations of SpO2 \<85%, heart rate \<45/min, heart rate \>130/min, respiratory rate \<4/min and respiratory rate \>30/min. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2 - Alerts Deemed Meaningful | During postoperative 72 hours | Fraction of alerts deemed as meaningful by clinicians/total alerts in unblinded group |
| Phase 2 - Clinical Interventions to Meaningful Alarms | During postoperative 72 hours | Number of clinical interventions by the three categories of meaningful alarms (informative, important, and critical). An investigator will ask the relevant clinician (usually a nurse) to rate each alert as clinically meaningful or not. Specifically, clinicians will be asked to rate alerts as critical, important, informative, or false or distracting. The terms will intentionally not be further defined, thereby allowing caregivers to determine themselves the extent to which a given alert was helpful or not. Caregivers will be queried in person shortly after each alert, typically within 15 minutes. The thresholds, determined in the initial phase, will be set to generate an average of about 2 alerts per patient per day - and therefore will not be onerous for clinicians. |
Countries
United States
Participant flow
Recruitment details
Phase 1 enrolled 100 patients with continuous vital sign monitoring blinded to patients and clinicians. Phase 2 randomized 150 patients to either blinded or unblinded continuous monitoring.
Pre-assignment details
Phase 1: A prospective observation cohort phase (no randomization) designed to identify suitable alert thresholds for continuous oxygen saturation, heart rate, and respiratory rate for phase 2. Patient characteristics weren't collected per protocol, ,and analysis was completely qualitative. Phase 2: A randomized trial phase. 176 patients consented, 26 patients withdrew before randomization: * 21 patients went to ICU after surgery * 5 patients declined to attend the study.
Participants by arm
| Arm | Count |
|---|---|
| Phase 2- Randomized Trial: Blinded GE Portrait Monitoring Continuous vital signs were monitored and recorded in patients assigned to blinded monitoring, but were not available to clinicians, who instead relied on routine vital sign assessments at 4-hour intervals. | 75 |
| Phase 2- Randomized Trial: Unblinded GE Portrait Monitoring Physician investigators monitored and evaluated continuous vital sign data 24 hours per day for patients assigned to unblinded GE Portrait monitoring. Patients who are randomized to the unblinded GE Portrait monitoring might be intervened if the clinicians believe that the alarm is clinically meaningful. | 73 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Phase 2- Randomized Trial: Unblinded GE Portrait Monitoring | Total | Phase 2- Randomized Trial: Blinded GE Portrait Monitoring |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 14 | 59 years STANDARD_DEVIATION 15 | 58 years STANDARD_DEVIATION 16 |
| American Society of Anesthesiologists (ASA) physical status Mild | 10 Participants | 21 Participants | 11 Participants |
| American Society of Anesthesiologists (ASA) physical status Moderate | 60 Participants | 122 Participants | 62 Participants |
| American Society of Anesthesiologists (ASA) physical status Normal | 0 Participants | 1 Participants | 1 Participants |
| American Society of Anesthesiologists (ASA) physical status Severe | 3 Participants | 4 Participants | 1 Participants |
| Body Mass Index | 28 kg/m^2 STANDARD_DEVIATION 6.2 | 28 kg/m^2 STANDARD_DEVIATION 7.1 | 28 kg/m^2 STANDARD_DEVIATION 7.6 |
| Race/Ethnicity, Customized Black | 8 Participants | 17 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 61 Participants | 123 Participants | 62 Participants |
| Sex: Female, Male Female | 41 Participants | 83 Participants | 42 Participants |
| Sex: Female, Male Male | 32 Participants | 65 Participants | 33 Participants |
| Smoking status Current | 9 Participants | 17 Participants | 8 Participants |
| Smoking status Former (> 6 weeks) | 22 Participants | 38 Participants | 16 Participants |
| Smoking status Never | 39 Participants | 85 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 73 | 0 / 75 |
| other Total, other adverse events | 0 / 100 | 0 / 73 | 0 / 75 |
| serious Total, serious adverse events | 0 / 100 | 0 / 73 | 0 / 75 |
Outcome results
Primary
Phase 2- Cumulative Duration of Vital Sign Abnormalities
The vital sign abnormalities is a 5-component composite including the durations of SpO2 \<85%, heart rate \<45/min, heart rate \>130/min, respiratory rate \<4/min and respiratory rate \>30/min.
Time frame: Up to 72 hours after surgery
Population: Monitor data for one patient in the blinded group was lost so we assumed that AET for all five outcomes were zero.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 2- Unblinded GE Portrait Monitoring | Phase 2- Cumulative Duration of Vital Sign Abnormalities | Respiratory rate < 4 breaths/min | 0 minutes beyond threshold |
| Phase 2- Unblinded GE Portrait Monitoring | Phase 2- Cumulative Duration of Vital Sign Abnormalities | Heart rate < 45 beats/min | 0.02 minutes beyond threshold |
| Phase 2- Unblinded GE Portrait Monitoring | Phase 2- Cumulative Duration of Vital Sign Abnormalities | Respiratory rate > 30 breaths/min | 8.4 minutes beyond threshold |
| Phase 2- Unblinded GE Portrait Monitoring | Phase 2- Cumulative Duration of Vital Sign Abnormalities | Heart rate > 130 beats/min | 0 minutes beyond threshold |
| Phase 2- Unblinded GE Portrait Monitoring | Phase 2- Cumulative Duration of Vital Sign Abnormalities | SPO2 < 85% | 6.2 minutes beyond threshold |
| Phase 2- Blinded GE Portrait Monitoring | Phase 2- Cumulative Duration of Vital Sign Abnormalities | Heart rate > 130 beats/min | 0 minutes beyond threshold |
| Phase 2- Blinded GE Portrait Monitoring | Phase 2- Cumulative Duration of Vital Sign Abnormalities | SPO2 < 85% | 4.2 minutes beyond threshold |
| Phase 2- Blinded GE Portrait Monitoring | Phase 2- Cumulative Duration of Vital Sign Abnormalities | Respiratory rate < 4 breaths/min | 0 minutes beyond threshold |
| Phase 2- Blinded GE Portrait Monitoring | Phase 2- Cumulative Duration of Vital Sign Abnormalities | Respiratory rate > 30 breaths/min | 10 minutes beyond threshold |
| Phase 2- Blinded GE Portrait Monitoring | Phase 2- Cumulative Duration of Vital Sign Abnormalities | Heart rate < 45 beats/min | 0.42 minutes beyond threshold |
p-value: <0.0595% CI: [0.51, 1.1]Distinct-effects GEE model
Secondary
Phase 2 - Alerts Deemed Meaningful
Fraction of alerts deemed as meaningful by clinicians/total alerts in unblinded group
Time frame: During postoperative 72 hours
Population: We analyzed 73 patients in the unblinded GE Portrait monitoring group, with a total of 73 alarms recorded. Among them, 41 patients experienced no alarms, while the remaining 32 patients accounted for all 73 alarms.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2- Unblinded GE Portrait Monitoring | Phase 2 - Alerts Deemed Meaningful | 60 Meaningful alarms |
Secondary
Phase 2 - Clinical Interventions to Meaningful Alarms
Number of clinical interventions by the three categories of meaningful alarms (informative, important, and critical). An investigator will ask the relevant clinician (usually a nurse) to rate each alert as clinically meaningful or not. Specifically, clinicians will be asked to rate alerts as critical, important, informative, or false or distracting. The terms will intentionally not be further defined, thereby allowing caregivers to determine themselves the extent to which a given alert was helpful or not. Caregivers will be queried in person shortly after each alert, typically within 15 minutes. The thresholds, determined in the initial phase, will be set to generate an average of about 2 alerts per patient per day - and therefore will not be onerous for clinicians.
Time frame: During postoperative 72 hours
Population: We analyzed 73 patients in the unblinded GE Portrait monitoring group, with a total of 73 alarms recorded. Among them, 41 patients experienced no alarms, while the remaining 32 patients accounted for all 73 alarms. Out of the 73 alarms, 60 alarms were categorized as informative, important, or critical by the responsible nurse.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Phase 2- Unblinded GE Portrait Monitoring | Phase 2 - Clinical Interventions to Meaningful Alarms | Informative alarm | 10 Meaningful alarms |
| Phase 2- Unblinded GE Portrait Monitoring | Phase 2 - Clinical Interventions to Meaningful Alarms | Important alarm | 21 Meaningful alarms |
| Phase 2- Unblinded GE Portrait Monitoring | Phase 2 - Clinical Interventions to Meaningful Alarms | Critical alarm | 2 Meaningful alarms |