Vital Signs Reduction Study

Not Applicable

Recruiting

• Conditions: Hospitalization

• Registration Number: NCT06865781
• Lead Sponsor: Intermountain Health Care, Inc.

Brief Summary

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.

Detailed Description

Patients will be screened at Primary Children's Hospital. Patients who are deemed eligible to forgo overnight vital signs will be considered for study. After written informed consent (parental permission/assent) is obtained, subjects who meet eligibility criteria will be allocated 1:1 to 2 treatment arms in sequential order: Group 1: standard of care vital signs monitoring and Group 2: no overnight vital signs at 0000 and 0400. The study period is approximately 24 hours, including one night of sleep. All participants will wear an actigraphy watch for one night and complete a sleep diary and sleep disruption survey after the study night. The primary endpoint is total sleep time, as measured by actigraphy. Secondary endpoints include nocturnal wake frequency, nocturnal wake duration (actigraphy), self-reported total sleep time (sleep diary), self-reported overnight disruptions (sleep diary), self-reported restfulness upon waking (sleep diary), self-reported sleep disturbances (sleep disturbance survey).

Study Timeline

• Study Start: 2024-07-17
• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Hospitalized at Primary Children's Hospital on units 3 Southeast, 3 Northeast, 3 Northwest
• Age 1-18 years
• Pediatric Early Warning Score ≤ 1 at 2000
• A parent/home caregiver present to consent to study
• Patient and home caregiver speak English or Spanish.
• Deemed appropriate for forgone overnight vital signs by care team (attending MD/Advanced Practice Provider and bedside RN).

Exclusion Criteria

• Pre-existing diagnosis of hypertension, kidney disease, pulmonary hypertension, chronic lung disease, congenital heart disease causing cardiopulmonary compromise, obstructive sleep apnea, seizure disorder, neuromuscular disability.
• Patients requiring O2 monitoring at home.
• The following medications in the previous 24 hours: opioids, intravenous immunoglobulin, intravenous magnesium, continuous albuterol, benzodiazepines, other sedating medications beyond home regimen.
• Anaphylaxis within 24 hours
• Within the first 24 hours post-operative period
• Requiring oxygen above baseline
• Fever in the last 24 hours.
• Sepsis alert in the last 72 hours.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total sleep time	From enrollment to end of treatment at 24 hours	Measured by actigraphy

Secondary Outcome Measures

Name	Time	Method
Restfulness upon waking	From enrollment to the end of treatment at 24 hours	By self report via sleep diary
Nocturnal wake frequency	From enrollment to the end of treatment at 24 hours	By actigraphy
Nocturnal wake duration	From enrollment to the end of treatment at 24 hours	By actigraphy
Total sleep time	From enrollment to the end of treatment at 24 hours	By self report via sleep diary
Overnight disruptions	From enrollment to the end of treatment at 24 hours	By self report via sleep diary
Sleep disturbances	From enrollment to the end of treatment at 24 hours	By self report via Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance survey

Trial Locations

Locations (1)

Intermountain Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States