Prolonged Mechanical Ventilation in Pediatric Intensive Care Unit Clinical Trial
— LVKOfficial title:
Prolonged Mechanical Ventilation in Paediatric Intensive Care : An International Cross-Sectional Prevalence Study
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.
| Status | Recruiting |
| Enrollment | 6000 |
| Est. completion date | September 4, 2022 |
| Est. primary completion date | September 3, 2021 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 37 Weeks to 18 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | CHU Sainte Justine | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| St. Justine's Hospital | Fonds de la Recherche en Santé du Québec, Réseau en Santé Respiratoire du Québec, Réseau mère-enfant de la francophonie, Women and Children's Health Research Institute, Canada |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevalence of PMV | number of patients meet PMV criteria devided by the number of patients admitted in PICUs on the specific data collection date and time. | eight times during two-year study period | |
| Secondary | Patient and treatment demographics | patient demographics underlying chronic disease acute disease leading to InMV or to NIV (i.e. reason of PMV) co-morbidities (Cerebral palsy, Seizure disorder, etc.) type of airway access MV mode and the days of ventilations for each mode care providers (e.g. intensivists, pediatric intensivists, anesthesiologist, paediatrician, pulmonologist) Nurse : patient ratio failed extubations or not during PMV location of patients on PMV (PICU or step down unit under PICU staff or not) Data from 8 study dates will be integrated into a summarized finding in the manuscript |
eight times during two-year study period | |
| Secondary | Outcomes at 90days follow-up | complications of mechanical ventilation mortality destination | 90 days from the initial data collection |