Study Results
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.
COMPLETED
NA
40 participants
INTERVENTIONAL
2019-09-13
2023-12-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This interventional physiology study will include 40 children on mechanical invasive ventilation.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Physiologic values will be monitored on different modes of ventilation in a randomized order. Each participant will be his own control regarding the different modes of ventilation. Monitoring will be done during 90 minutes for each mode of ventilation.
Participant will have two different phases of ventilation. The first one is the passive phase (participant does not trigger the ventilator cycle sustainly) in which ASV and Pressure-Control Ventilation will be performed in a randomized order. The second phase will be the active ventilation phase (participant does trigger the ventilator cycle sustainly) in which ASV and Pressure-Support Ventilation will be performed in a randomized order.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
In each phase, two different modes of ventilation will be performed in a randomized order and will be monitored (Pressure-Control Ventilation and ASV during the passive ventilation phase, Pressure-Support Ventilation and ASV during the active ventilation phase). Washout periods will be performed between the different modes of ventilation.
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Passive phase, Pressure-Control Ventilation / ASV order
90 minutes of Pressure-Control Ventilation, change to ASV mode with 15 to 30 minutes of washout, 90 minutes of ASV. Return to Pressure-Control Ventilation mode at the end of the intervention.
ASV ventilation
Ventilation on ASV mode
Passive phase, ASV / Pressure-Control Ventilation order
90 minutes of ASV, change to Pressure-Control Ventilation mode with 15 to 30 minutes of washout, 90 minutes of Pressure-Control Ventilation.
ASV ventilation
Ventilation on ASV mode
Active phase, Pressure-Support / ASV order
90 minutes of Pressure-Support Ventilation, change to ASV mode with 15 to 30 minutes of washout, 90 minutes of ASV. Return to Pressure-Support Ventilation at the end of the intervention.
ASV ventilation
Ventilation on ASV mode
Active phase, ASV / Pressure-Support order
90 minutes of ASV, change to Pressure-Support Ventilation with 15 to 30 minutes of washout, 90 minutes of Pressure-Support Ventilation.
ASV ventilation
Ventilation on ASV mode
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ASV ventilation
Ventilation on ASV mode
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body weight \> 6kg
* Absence of pulmonary comorbidity
* Age \< 10 years
Exclusion Criteria
* body weight \< 6kg
* age \> 10 years
* more than 20% of air leak around endotracheal tube
* chronic or acute pulmonary disease (ARDS, cystic fibrosis, severe asthma, lobectomy, severe bronchomalacia or severe tracheomalacia)
* severe pulmonary hypertension on inhaled nitric oxide treatment
* severe hemodynamic instability (more than 0.5mcg/kg/min of norepinephrine infusion or other high dose vasoactive agent infusion)
* intracranial hypertension (more than 20mmHg if measured) or suspected intracranial hypertension
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Lausanne Hospitals
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
FERRY Thomas
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Ferry, MD
Role: PRINCIPAL_INVESTIGATOR
University of Lausanne Hospitals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lausanne University Hospital
Lausanne, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ASV ventilation in children
Identifier Type: -
Identifier Source: org_study_id