LongVentKids Study

NCT04112459 | Unknown

• 1 other identifier: MP-21-2019-2130
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient and treatment demographics

  eight times during two-year study period

• Outcomes at 90days follow-up

  90 days from the initial data collection

Interventions

prolonged mechanical ventilation OTHER

No intervention will be applied in this study

Eligibility Criteria

• Age: 37 Weeks - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Réseau en Santé Respiratoire du Québec: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator
• Women and Children's Health Research Institute, Canada: collaborator
• Réseau mère-enfant de la francophonie: collaborator

Study Sites (1)

CHU Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Related Publications (1)

• Kawaguchi A, Fernandez A, Baudin F, Chiusolo F, Lee JH, Brierley J, Colleti J Jr, Reiter K, Won Kim K, Lopez Fernandez Y, Kneyber M, Pons-Odena M, Napolitano N, Graham RJ, Kawasaki T, Garros D, Garcia Guerra G, Jouvet P; LongVentKids study group. Prevalence, management, health-care burden, and 90-day outcomes of prolonged mechanical ventilation in the paediatric intensive care unit (LongVentKids): an international, prospective, cross-sectional cohort study. Lancet Child Adolesc Health. 2025 Jan;9(1):37-46. doi: 10.1016/S2352-4642(24)00296-7.

  PMID: 39701660 DERIVED

Study Officials

• Philippe Jouvet, MD PhD MBA

  St. Justine's Hospital

  STUDY DIRECTOR

Central Study Contacts

Atsushi Kawaguchi, MD PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Scholar

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 2, 2019
• Study Start: September 4, 2019
• Primary Completion: September 3, 2021
• Study Completion: September 4, 2022
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: All the study protocol and CRF will be shared with the participating centers.

Locations

CA (1)