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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if skipping overnight vital checks can improve sleep quality for hospitalized children. Nurses typically check vital signs every four hours, often waking children. The study will compare children who skip these checks with those who continue to have them. It is suitable for children aged 1 to 18 who are hospitalized and do not have conditions like chronic lung disease or recent fevers. A caregiver who speaks English or Spanish must consent for participants. As an unphased trial, this study offers a unique opportunity for children to potentially experience better sleep during their hospital stay.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've taken certain medications like opioids or sedatives in the past 24 hours.

What prior data suggests that forgoing overnight vital signs is safe for hospitalized children?

Research has shown that skipping some overnight vital sign checks for hospitalized children might be safe. One study found that reducing these checks decreased sleep interruptions from 24% to 8%. This suggests that not checking vital signs at night could improve sleep without causing harm.

Another study examined whether these checks led to new health problems and found that routine overnight checks rarely caused new issues for stable children. This indicates that skipping these checks might not increase risks for children.

Overall, these findings suggest that skipping some overnight vital sign checks could be safe and may help hospitalized children sleep better. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of forgoing overnight vital sign checks for hospitalized children. Unlike the standard practice, which involves waking patients at night for monitoring, this approach allows children to have uninterrupted sleep. The main idea is that better sleep might help kids recover faster by reducing stress and improving overall rest. This trial could lead to a new standard of care, enhancing the hospital experience for young patients while potentially improving health outcomes.

What evidence suggests that forgoing overnight vital signs is effective for improving sleep quality in hospitalized children?

This trial will compare the effects of forgoing overnight vital signs with standard care in hospitalized children. Research has shown that checking vital signs at night often interrupts children's sleep in hospitals. Studies have identified these checks as a major reason for poor sleep in acute care units. Early evidence suggests that skipping unnecessary checks at night might improve children's sleep. Specifically, one study aimed to reduce sleep disruptions by 10% over a year by cutting down on these checks. Thus, skipping some nighttime checks could enhance sleep without compromising patient care. ^{1 2 3 6 7}

Who Is on the Research Team?

Leandra Bitterfeld, MSN

Principal Investigator

Intermountain Primary Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40246301/

Improving Sleep by Minimizing Unnecessary Overnight ...

Our primary outcome measures were a composite of all overnight VS measurements, as well as blood pressure (BP) measurements individually.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06865781

Study Details | NCT06865781 | Vital Signs Reduction Study

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- ...

3.

withpower.com

withpower.com/trial/phase-hospitalizations-6-2024-f0087

Forgoing Overnight Vital Signs for Hospitalized Children

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 ...

4.

journals.lww.com

journals.lww.com/pqs/fulltext/2023/07000/quasi_experimental,_nonrandomized_initiative_to.8.aspx

Quasi-experimental, Nonrandomized Initiative to Minimize...

We aimed to reduce caregiver-reported sleep disruptions of children hospitalized on the pediatric hospital medicine service by 10% over 12 months.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37442685/

Understanding the effects of overnight vital signs ...

Results: Vital signs monitoring is the most common sleep disruptor among hospitalized children in acute care units and early evidence ...

6.

researchgate.net

researchgate.net/publication/372298135_Quasi-experimental_Nonrandomized_Initiative_to_Minimize_Sleep_Disruptions_among_Hospitalized_Children

Quasi-experimental, Nonrandomized Initiative to Minimize ...

Overall, caregivers reported sleep disruptions on 24% (99/419) of reported nights preintervention, which decreased to 8% (195/2,313) ...

7.

medschool.lsuhsc.edu

medschool.lsuhsc.edu/batonrouge/docs/abstracts/BR/31_Let%20the%20kids%20sleep.pdf

Assessing the utility of routine overnight vital sign assessment ...

To determine the frequency with which routine overnight vital sign assessment resulted in new adverse clinical events in stable pediatric surgery patients.