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Identifying At-Risk Patients and Predicting Deterioration of In-Patients Using Continuous Heart Rate, Respiratory Rate, and Movement Monitoring

Identifying At-Risk Patients and Predicting Deterioration of In-Patients Using Continuous Heart Rate, Respiratory Rate, and Movement Monitoring

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03010774
Enrollment
166
Registered
2017-01-05
Start date
2017-02-14
Completion date
2018-12-31
Last updated
2020-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Quality

Brief summary

Currently, all patients in the hospital are woken up throughout the night to check for vital signs, no matter how sick they are. The investigators are doing this study to determine whether skipping routine vital sign checks at night improves participant sleep quality and satisfaction without increasing the risk of adverse events.

Detailed description

The purpose of this study is: 1. To determine the correlation between subjective and objective sleep quality measures. 2. To compare the objective and subjective measures of sleep quality and satisfaction between the intervention group and the control group. 3. To compare the adverse event rates in the intervention group and the control group, defined as ICU transfer or cardiac arrest occurring within 24 hours of risk stratification.

Interventions

BEHAVIORALRisk Stratification

Every night, subjects will be risk stratified into low-risk or medium- to high-risk using a physiologic risk score, eCART. Subjects who meet the low-risk criteria will not be woken up for routine nighttime vitals (typically at midnight and at 4 am). However, subjects will continue to be woken up for laboratory draws, procedures, or treatments as per usual. Subjects who are medium- to high-risk will continue to be woken up at night for routine nighttime vitals. Alarms for all subjects, including low-risk subjects, will continue to alert nurses in real-time. If the primary nurse of a low-risk subject is alerted of an alarm, the nurse will have to go into the subject's room to turn off the alarm and therefore check on the patient.

BEHAVIORALUsual Care

The subject will continue to receive routine vital sign measurements and charting, standard for the ward or according to the physician orders, including routine spot-check vital signs, regardless of risk level.

Sponsors

EarlySense Ltd.
CollaboratorINDUSTRY
University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years and older * Hospitalized on study unit

Exclusion criteria

* Inability to provide consent * Non-English speaking * Order for physical wound checks * Order for cardiac telemetry monitoring

Design outcomes

Primary

MeasureTime frameDescription
Sleep Quality5 daysPittsburgh Sleep Quality Index

Secondary

MeasureTime frameDescription
Adverse Event Ratewithin 24 hours of risk stratificationICU transfer or cardiac arrest

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026