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

Sleep Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010774
• Other study ID #: IRB13-0885
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 31, 2018
• Est. primary completion date: November 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Quality

Intervention

Behavioral:
• Risk 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.
• Usual 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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	EarlySense Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality	Pittsburgh Sleep Quality Index	5 days
Primary	Sleep Quality	Karolinska Sleep Log	5 days
Primary	Sleep Quality	Potential Hospital Sleep Disruptions and Noises Questionnaire	5 days
Secondary	Adverse Event Rate	ICU transfer or cardiac arrest	within 24 hours of risk stratification