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OpenTrials
Completed

NCT Number: NCT03010774

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

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.

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Key information

Conditions

Sleep Quality Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

The purpose of this study is:

  • To determine the correlation between subjective and objective sleep quality measures.
  • To compare the objective and subjective measures of sleep quality and satisfaction between the intervention group and the control group.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risk Stratification

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Sleep Quality

    Time frame: 5 days

    Pittsburgh Sleep Quality Index

  2. Sleep Quality

    Time frame: 5 days

    Karolinska Sleep Log

  3. Sleep Quality

    Time frame: 5 days

    Potential Hospital Sleep Disruptions and Noises Questionnaire

Secondary outcomes

  1. Adverse Event Rate

    Time frame: within 24 hours of risk stratification

    ICU transfer or cardiac arrest

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • EarlySense Ltd.

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2017
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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