Recruiting

Observational Study

Sponsor:

St. Justine's Hospital

Code:

NCT04112459

Conditions

Prolonged Mechanical Ventilation in Pediatric Intensive Care Unit

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

prolonged mechanical ventilation

Study Details

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.

Conditions

Prolonged Mechanical Ventilation in Pediatric Intensive Care Unit

Study ID

NCT04112459

Start date

Sep 4, 2019

Status verified date

Sep, 2019

Completion date

Sep 4, 2022

Anticipated

Primary completion date

Sep 3, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

6000 participants

Anticipated

Interventions and Outcome Measures

Interventions

prolonged mechanical ventilation

No intervention will be applied in this study

Primary outcome measure

  • Prevalence of PMV [ Time Frame: eight times during two-year study period ]

Central Contacts and Locations

Central contacts

Atsushi Kawaguchi, MD PhD

+1-(514)912-4247atsushi@ualberta.ca

Locations

CHU Sainte Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Atsushi Kawaguchi

atsushi@ualberta.ca

More Information

Sponsor

St. Justine's Hospital

Last update posted

Oct 2, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2019-10-02.