LongVentKids Study (LVK)

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.

Study Overview

• Status: Unknown
• Conditions: Prolonged Mechanical Ventilation in Pediatric Intensive Care Unit
• Intervention / Treatment: Other: prolonged mechanical ventilation

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

• Study Contact: Name: Atsushi Kawaguchi, MD PhD; Phone Number: +1-(514)912-4247; Email: atsushi@ualberta.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • Recruiting
      • CHU Sainte Justine
      • Contact: Atsushi Kawaguchi; Email: atsushi@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Outcomes at 90days follow-up	complications of mechanical ventilation mortality destination	90 days from the initial data collection

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Collaborators: Women and Children's Health Research Institute, Canada; Fonds de la Recherche en Santé du Québec; Réseau en Santé Respiratoire du Québec; Réseau mère-enfant de la francophonie
• Investigators: Study Director: Philippe Jouvet, MD PhD MBA, St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 4, 2019
• Primary Completion (ANTICIPATED): September 3, 2021
• Study Completion (ANTICIPATED): September 4, 2022

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MP-21-2019-2130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing agreement will be mandatory to be signed between the central coordination center (CHU Sainte Justine) and the participating center.
• IPD Sharing Time Frame: After all the data collection completed, summarized de-identified study result will be shared with the participating centers. Patient individual data will be shared between the central coordinating center and the center where PI of ancillary and posthoc study belongs.
• IPD Sharing Access Criteria: All the study protocol and CRF will be shared with the participating centers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No