Prolonged Mechanical Ventilation in Pediatric Intensive Care UnitLVKNCT04112459
LongVentKids Study
An observational study of Prolonged Mechanical Ventilation in Pediatric Intensive Care Unit, run by St. Justine's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 37 weeks to 18 years
- Conditions the study is for
- Prolonged Mechanical Ventilation in Pediatric Intensive Care Unit
- What is being tested?
- prolonged mechanical ventilation
- How many people
- 6,000 participants
- Where
- 1 siteCanada
- Study dates
- 4 Sep 2019to 4 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 weeks to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Age >18 years
- Already included in this study
- No consent if required
- Brain death
- Premature children not yet at 37 weeks gestational age.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte Justine
Montreal, Quebec, H3T 1C5
Atsushi Kawaguchi, atsushi@ualberta.ca
About this study
Official 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.
- Being tested
- prolonged mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prolonged mechanical ventilationOther
No intervention will be applied in this study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: eight times during two-year study period
Secondary outcomes (2)
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
Measured: eight times during two-year study period
Outcomes at 90days follow-up
complications of mechanical ventilation mortality destination
Measured: 90 days from the initial data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start4 Sep 2019
- Primary completion3 Sep 2021 (estimated)
- Study completion4 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged Mechanical Ventilation in Pediatric Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Réseau en Santé Respiratoire du Québec, Fonds de la Recherche en Santé du Québec, Women and Children's Health Research Institute, Canada, Réseau mère-enfant de la francophonie
- Responsible party
- Principal investigator, Atsushi Kawaguchi, St. Justine's Hospital
- Investigators
- Philippe Jouvet, MD PhD MBA, Study director, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112459
- Sponsor's protocol ID
- MP-21-2019-2130
- Acronym
- LVK
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing agreement will be mandatory to be signed between the central coordination center (CHU Sainte Justine) and the participating center.
Publications
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.
PubMed 39701660
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Mechanical Ventilation in Paediatric Intensive Care : An International Cross-Sectional Prevalence Study
- ClinicalTrials.gov ID
- NCT04112459
- Acronym / sponsor ID
- LVK / MP-21-2019-2130
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Réseau en Santé Respiratoire du Québec, Fonds de la Recherche en Santé du Québec, Women and Children's Health Research Institute, Canada, Réseau mère-enfant de la francophonie
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 3 Sep 2021 (estimated)
- Study completion
- 4 Sep 2022 (estimated)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 37 weeks to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- Age >18 years
- Already included in this study
- No consent if required
- Brain death
- Premature children not yet at 37 weeks gestational age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prolonged mechanical ventilationNo intervention will be applied in this study | Other | – |
Primary outcome
Prevalence of PMV
Time frame: eight times during two-year study period
number of patients meet PMV criteria devided by the number of patients admitted in PICUs on the specific data collection date and time.
2 secondary outcomes
Patient and treatment demographics
Time frame: eight times during two-year study period
Outcomes at 90days follow-up
Time frame: 90 days from the initial data collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Derived from this study: PubMed 39701660Kawaguchi 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.
- Individual participant dataSharing planned: Yes. Data sharing agreement will be mandatory to be signed between the central coordination center (CHU Sainte Justine) and the participating center.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Jouvet, MD PhD MBA study director
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolonged Mechanical Ventilation in Pediatric Intensive Care Unit, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atsushi Kawaguchi, MD PhD (+1-(514)912-4247, atsushi@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of PMV (time frame: eight times during two-year study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04112459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.