A Study on Noise Exposure Status and the Effect of Noise Management in Pediatric Intensive Care Unit

NCT04544085 | Unknown

• 1 other identifier: XH-20-016
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

This study has two stages. At the first stage,the investigators will try to use noise detectors to investigate the status of noise exposure in the pediatric intensive care unit(PICU) and to analyze the main noise sources in it. At the second stage,the investigators will try to evaluate the effect of noise management on noise exposure and health outcomes of the pediatric patients in PICU.The investigators hypothesize that noise exposure in PICU is higher than the standard.The investigators also hypothesize that the implementation of the noise management will improve the noise exposure and health outcomes of the pediatric patients in PICU.

Conditions

Noise Exposure; Delirium

Keywords

Noise Exposure; Delirium; pediatric; intensive care

Outcome Measures

Primary Outcomes (2)

• Noise exposure

  Noise is measured in decibels.The noise exposure in PICU will be described in Leq,Lmax,Lmin

  Average of 1 weak

• Delirium incidence

  Delirium screening is performed using the Cornell assessment of pediatric delirium(CAPD).Delirium will be screened every 12 hours(at 8:00a.m.\&20:00p.m.) until the patient is transferred out of PICU or drops out

  Up to 1 month

Secondary Outcomes (4)

• PICU length of stay(LOS)

  60 days after the enrollment

• Duration of mechanical ventilation(MV)

  60 days after the enrollment

• Hospital length of stay(LOS)

  60 days after the enrollment

• Medical staff's knowledge of noise management

  1 hour within the end of the lecture on noise management for medical staff

Study Arms (2)

control group

NO INTERVENTION

Patients in the control group will not receive any noise management intervention

experimental group

EXPERIMENTAL

Patients in the experimental group will receive noise management. The intervention measures mainly include the following three parts: control of noise source, control of noise transmission and personal protection of noise receiver.We will strengthen the education of medical staff to ensure the effective implementation of the noise management.

Behavioral: noise management

Interventions

noise management BEHAVIORAL

The intervention mainly includes the following three parts: control of noise source, control of noise transmission and personal protection of noise receiver.(1) control of noise source:equipment maintenance,alarm management,set quiet time,etc.;(2)control of noise transmission:improvement of architectural design;(3)personal protection of noise receiver:providing patients with earmuffs or earplugs.

experimental group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged ≤ 18 years
• The predicted PICU LOS ≥12 hours
• The informed consent of the child's guardian was obtained

You may not qualify if:

• Patients with delirium on admission
• Patients in a coma (Richmond Agitation Sedation Scale\[RASS\]-4 or -5) all through their stay in PICU
• Patients with mental disorders or mental retardation, who continue to use antipsychotic drugs
• Patients undergoing neurosurgery and neurology surgery
• Hearing or visual impairment
• Non Chinese or English language users
• Missed or incomplete delirium score

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Xiaohua Ge

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohua Ge

CONTACT

+86-18616706778; gexiaohua@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 10, 2020
• Study Start: July 16, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-08

Locations

CN (1)