Vital Signs Reduction Study

Intermountain Health Care, Inc.

Status

Active, not recruiting

Conditions

Hospitalization

Treatments

Other: Forgone overnight vital signs

Study type

Interventional

Funder types

Other

Identifiers

NCT06865781

1052853

Details and patient eligibility

About

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.

Full 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).

Enrollment

160 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

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.