Forgoing Overnight Vital Signs for Hospitalized Children

Overseen By Leandra Bitterfeld, MSN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Intermountain Health Care, Inc.

Must not be taking: Opioids, Benzodiazepines, others

Disqualifiers: Hypertension, Kidney disease, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 24 hours

160 Participants Needed

Trial Summary

What is the purpose of this trial?

Overnight vital signs are typically done every four hours on pediatric acute care units, despite limited evidence supporting the efficacy of this practice. Additionally, vital signs are often ordered and collected without considering the patient's clinical status or the potential impact that they may have on sleep. The purpose of this study is to understand the effect of forgone overnight vital signs on sleep quality and duration among children hospitalized in medical-surgical units, compared with children who receive standard of care vital signs.

Research Team

Leandra Bitterfeld, MSN

Principal Investigator

Intermountain Primary Children's Hospital

Eligibility Criteria

This trial is for children hospitalized in medical-surgical units who typically have their vital signs checked every four hours overnight. Specific eligibility criteria are not provided, but it's implied that participants should be affected by the current standard of care for vital sign monitoring.

Inclusion Criteria

Pediatric Early Warning Score ≤ 1 at 2000

Hospitalized at Primary Children's Hospital on units 3 Southeast, 3 Northeast, 3 Northwest

A parent/home caregiver present to consent to study

Exclusion Criteria

I have been alerted to a possible sepsis infection in the last 3 days.

I have had a fever in the last 24 hours.

Anaphylaxis within 24 hours

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants are allocated to either standard of care vital signs monitoring or no overnight vital signs for one night

24 hours

1 visit (in-person)

Follow-up

Participants complete a sleep diary and sleep disruption survey after the study night

1 day

1 visit (in-person)

Treatment Details

Interventions

• Forgone overnight vital signs

Trial Overview The study is testing whether skipping overnight vital sign checks can improve sleep quality and duration in pediatric patients compared to those who receive the usual care of having their vitals monitored throughout the night.

Participant Groups

Group I: Intervention group Experimental Treatment 1 Intervention

Will not receive vital signs at 0000 or 0400 of study night.

Group II: Control group Active Control 1 Intervention

Receive standard of care vital signs

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+