Clinical Trials Directory

Trials / Completed

CompletedNCT03010774

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
166 (actual)
Sponsor
University of Chicago · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALRisk StratificationEvery 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 CareThe 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.

Timeline

Start date
2017-02-14
Primary completion
2018-11-10
Completion
2018-12-31
First posted
2017-01-05
Last updated
2020-03-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03010774. Inclusion in this directory is not an endorsement.