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Clinical Trials/NCT04112459
NCT04112459
Unknown
N/A

Prolonged Mechanical Ventilation in Paediatric Intensive Care : An International Cross-Sectional Prevalence Study

St. Justine's Hospital1 site in 1 country6,000 target enrollmentSeptember 4, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prolonged Mechanical Ventilation in Pediatric Intensive Care Unit
Sponsor
St. Justine's Hospital
Enrollment
6000
Locations
1
Primary Endpoint
Prevalence of PMV
Last Updated
6 years ago

Overview

Brief Summary

Scientific advances, population growth, lower mortality, and increasing complexity of diseases have boosted up the number of patients requiring prolonged breathing assistance with mechanical ventilators in the pediatric intensive care units (PICU) in many parts of the developed world. Previous studies also suggest that there is a small group of children who actually need such a high level of support for extended periods of time, utilizing a lot of human and technical resources. We defined children with prolonged mechanical ventilation (PMV) if they required supports with a breathing machine for more than 14 days. We propose an international point prevalence study of children requiring PMV in PICU. We will conduct the study in multiple centers in several different regions, including North and South America, Europe, and Asian countries, with a strong relationship with local physician colleagues. Practice for patients requiring PMV will be examined including the type and size of local PICU, admission and discharge policies, and patient and treatment modalities administered to such patients, types of professionals looking after patients in PMV, types of health care. We anticipate a high variability in practices suggesting a need to further standardize the management of PMV.. Specifically, as an immediate consequence, by comparing and understanding the differences in patient demographics, practice details among PICUs in regards to the background factors of local PICUs and their patients, practitioners will share their way of dealing with such patients. In that way, this study will support the need to generate guidelines and lead to patient care improvement in PICUs.

Registry
clinicaltrials.gov
Start Date
September 4, 2019
End Date
September 4, 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St. Justine's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Atsushi Kawaguchi

Postdoctoral Scholar

St. Justine's Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients who are ventilated \>14 consecutive days (after 37 weeks postmenstrual post-conception age)\*
  • including for more than 6 hours per day including on InMV and NIV duration
  • patient who have had and short interruptions (\<48hours) of ventilation during the weaning process as the same episode of ventilation can be included.
  • InMV can be administered through an endotracheal tube or a tracheostomy tube.
  • NIV can be managed through a nasal, full-face, total facial mask, or helmet.
  • Patient on HFNC will be included as on respiratory support if they have a proper or a nasal cannula (that allows \>=1 liters/kg/min (LPM) and \>4LPM).
  • We define nasal oxygen supply \<1 L/kg/min as non-NIV practice.

Exclusion Criteria

  • Age \>18 years
  • Already included in this study
  • No consent if required
  • Brain death
  • Premature children not yet at 37 weeks gestational age.

Outcomes

Primary Outcomes

Prevalence of PMV

Time Frame: eight times during two-year study period

number of patients meet PMV criteria devided by the number of patients admitted in PICUs on the specific data collection date and time.

Secondary Outcomes

  • Patient and treatment demographics(eight times during two-year study period)
  • Outcomes at 90days follow-up(90 days from the initial data collection)

Study Sites (1)

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