LongVentKids Study

NCT ID: NCT04112459

Last Updated: 2019-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-04

Study Completion Date

2022-09-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prolonged Mechanical Ventilation in Pediatric Intensive Care Unit

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

prolonged mechanical ventilation

No intervention will be applied in this study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

37 Weeks

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Réseau en Santé Respiratoire du Québec

UNKNOWN

Sponsor Role collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role collaborator

Women and Children's Health Research Institute, Canada

OTHER

Sponsor Role collaborator

Réseau mère-enfant de la francophonie

UNKNOWN

Sponsor Role collaborator

St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Atsushi Kawaguchi

Postdoctoral Scholar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philippe Jouvet, MD PhD MBA

Role: STUDY_DIRECTOR

St. Justine's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Sainte Justine

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Atsushi Kawaguchi, MD PhD

Role: CONTACT

+1-(514)912-4247

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Atsushi Kawaguchi

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39701660 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MP-21-2019-2130

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oxy-PICU Neurodevelopmental Follow-up Study
NCT06734715 NOT_YET_RECRUITING