Vital Signs Reduction Study

NCT06865781 | Active Not Recruiting

• 1 other identifier: 1052853
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospitalization

Keywords

pediatric; hospitalization; vital signs; sleep

Outcome Measures

Primary Outcomes (1)

• Total sleep time

  Measured by actigraphy

  From enrollment to end of treatment at 24 hours

Secondary Outcomes (6)

• Nocturnal wake frequency

  From enrollment to the end of treatment at 24 hours

• Nocturnal wake duration

  From enrollment to the end of treatment at 24 hours

• Total sleep time

  From enrollment to the end of treatment at 24 hours

• Overnight disruptions

  From enrollment to the end of treatment at 24 hours

• Restfulness upon waking

  From enrollment to the end of treatment at 24 hours

Study Arms (2)

Control group

NO INTERVENTION

Receive standard of care vital signs

Intervention group

EXPERIMENTAL

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

Other: Forgone overnight vital signs

Interventions

Forgone overnight vital signs OTHER

No vital signs (temp, heart rate, respiratory rate, blood pressure, oxygen saturation) taken at 0000 or 0400

Intervention group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Primary Children's Hospital

Salt Lake City, Utah, 84112, United States

Location

Study Officials

• Leandra Bitterfeld, MSN

  Intermountain Primary Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: July 17, 2024
• Primary Completion: May 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)