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

NCT04777695 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2021-10-01

No results posted yet for this study

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

Interventions

OTHER

Decibel Monitor

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.

Sponsors & Collaborators

  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • Gregory Yurasek, MD · Children's National Research Institute

Eligibility

Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-05-01
Completion
2021-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04777695 on ClinicalTrials.gov