Clinical trial NCT04112459: LongVentKids Study
Official title: Prolonged Mechanical Ventilation in Paediatric Intensive Care : An International Cross-Sectional Prevalence Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prolonged Mechanical Ventilation in Pediatric Intensive Care Unit
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Réseau en Santé Respiratoire du Québec
name: Fonds de la Recherche en Santé du Québec
name: Women and Children's Health Research Institute, Canada
name: Réseau mère-enfant de la francophonie
First posted: 2019-10-02
Enrollment: 6000
Sex: ALL
Minimum age (years): 37
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients on invasive or non-invasive mechanical ventilation on the day of the study or patients who had been on InMV or non-invasive ventilation (NIVs) during their PICU stays will be eligible. Patients who fulfill inclusion criteria and do not meet any exclusion criteria will be considered for inclusion in the study.

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.


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.

Primary outcomes:
measure: Prevalence of PMV
timeFrame: eight times during two-year study period
Secondary outcomes:
measure: Patient and treatment demographics
timeFrame: eight times during two-year study period
measure: Outcomes at 90days follow-up
timeFrame: 90 days from the initial data collection
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte Justine
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Philippe Jouvet, MD PhD MBA
role: STUDY_DIRECTOR
References: