Delirium Clinical Trial
Official title:
A Study on Noise Exposure Status and the Effect of Noise Management in Pediatric Intensive Care Unit
NCT number | NCT04544085 |
Other study ID # | XH-20-016 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 16, 2020 |
Est. completion date | December 2020 |
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.
Status | Recruiting |
Enrollment | 204 |
Est. completion date | December 2020 |
Est. primary completion date | November 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - Patients aged = 18 years - The predicted PICU LOS =12 hours - The informed consent of the child's guardian was obtained Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Noise exposure | Noise is measured in decibels.The noise exposure in PICU will be described in Leq,Lmax,Lmin | Average of 1 weak | |
Primary | 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 | PICU length of stay(LOS) | PICU LOS is measured in days | 60 days after the enrollment | |
Secondary | Duration of mechanical ventilation(MV) | Duration of MV is measured in days | 60 days after the enrollment | |
Secondary | Hospital length of stay(LOS) | Hospital LOS is measured in days | 60 days after the enrollment | |
Secondary | Medical staff's knowledge of noise management | Medical staff's knowledge of noise management is evaluated by a self-made questionnaire | 1 hour within the end of the lecture on noise management for medical staff |
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