Sound Levels in the Pediatric Cardiac Critical Care Unit and Their Correlation With Sedation Administration, Delirium Scores and Patient Heart Rate

NCT04777695 | Completed

• 1 other identifier: Pro00013873
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

There is limited data regarding sound levels and burden in the pediatric cardiac critical care unit and how this compares with WHO standards. We seek to record this data and correlate sound level with bolus sedation administration, patient delirium scores, and patient heart rate trends. Primary Outcomes

• 1 peak sound level in cardiac ICU in decibels
• 2 Mean sound level in cardiac ICU in decibels
• 3 Compare sound levels to WHO recommendations Secondary Outcomes
• 1 To explore patient and unit factors that might influence these levels
• 2 To analyze sound levels in post-operative neonates, versus infants, versus children
• 3 To analyze patients on invasive versus non-invasine versus no ventilation

Conditions

Noise Exposure; Sedative Withdrawal Delirium; Sedative Toxicity

Outcome Measures

Primary Outcomes (1)

• To measure peak and mean sound levels in a cardiac ICU as well as sound dose and to compare this exposure to WHO recommendations

  1 month

Secondary Outcomes (3)

• To correlate sound levels and sound dose with bolus sedation administered to these patients

  1 month

• To correlate sound levels and sound dose with delirium scores in these patients

  1 month

• To correlate sound levels and sound dose with patient heart rate

  1 month

Other Outcomes (1)

• To explore patient and unit factors that might influence these levels a. To analyze sound levels in post-operative neonates, versus infants, versus children b. To analyze patients on invasive versus non-invasine versus no ventilation

  1 month

Study Arms (1)

CICU Inpatients

This is a prospective observational study of all children admitted to the pediatric CICU during a one month period of time for patients aged 0 to less than or equal to 22 years of age, as per the World Health Organization definition of a pediatric patient.

Other: Decibel Monitor

Interventions

Decibel Monitor OTHER

Placement of a TeckPro data logging sound decibel meter at all patient bed-spaces to measure concurrent sound levels 24 hours per day, over a one (1) month period. Peak and mean sound levels per hour will be collected by the decibel monitor. Sound collected every 5 minutes will be logged by the decibel monitor and downloaded onto manufacturer software daily; data will then be imported into Microsoft Excel for further data analysis.

CICU Inpatients

Eligibility Criteria

• Age: Up to 22 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Cardiac Critical Care patients include patients admitted for evaluation of congenital heart disease, status post repair of that disease, arrhythmia or for other management of pediatric patients with these conditions.

You may qualify if:

• All children admitted to the pediatric CICU during a one month period of time for patients aged 0 to less than or equal to 22 years of age, as per the World Health Organization definition of a pediatric patient.

You may not qualify if:

• None

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• Garcia Guerra G, Joffe AR, Sheppard C, Pugh J, Moez EK, Dinu IA, Jou H, Hartling L, Vohra S; SedationWithdrawal and Analgesia Team (SWAT); Canadian Critical Care Trials Group (CCCTG). Prospective cohort study on noise levels in a pediatric cardiac intensive care unit. J Crit Care. 2018 Apr;44:318-322. doi: 10.1016/j.jcrc.2017.12.008. Epub 2017 Dec 14.

  PMID: 29274594 RESULT

Study Officials

• Gregory Yurasek, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 2, 2021
• Study Start: March 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)