Vital Signs Reduction Study

NCT ID: NCT06865781

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-17
• Study Completion Date: 2025-11-30

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).

Conditions

Hospitalization

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control group

Receive standard of care vital signs

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

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

Group Type: EXPERIMENTAL

Forgone overnight vital signs

Intervention Type: OTHER

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

Interventions

Forgone overnight vital signs

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leandra Bitterfeld, MSN

Role: PRINCIPAL_INVESTIGATOR

Intermountain Primary Children's Hospital

Locations

Intermountain Primary Children's Hospital

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1052853

Identifier Type: -

Identifier Source: org_study_id