Comparison of Gas Exchange Between Two Invasive Mechanical Ventilation Modes in Children
NCT ID: NCT05843123
Last Updated: 2024-12-13
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
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COMPLETED
PHASE4
59 participants
INTERVENTIONAL
2024-01-15
2024-09-20
Brief Summary
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This is a single-center, open-labelled, randomized controlled trial with two parallel 1:1 treatment arms: pressure controlled (PC) vs pressure-regulated volume controlled (PRVC) mechanical ventilation modes.
Use to routine digital data is essential to enable health learning systems and to provide rapid clinical trials readiness, as the pandemic has demonstrated. Despite availability of data to perform digital trials in PICU settings, these are yet scarcely done.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Pressure control (PC)
In PC physicians set the inspiratory pressure and time, the respiratory rate and the PEEP while the ventilator measures tidal volume and the actual respiratory rate
Respiratory support b
Invasive mechanical ventilation mode
Pressure regulated volume control (PRVC)
In PRVC physicians set a target tidal volume and the respiratory rate. An algorithm delivers pressure using a decelerating flow pattern to reach the target tidal volume based on the lung compliance measured during previous breaths.
Respiratory support a
Invasive mechanical ventilation mode
Interventions
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Respiratory support a
Invasive mechanical ventilation mode
Respiratory support b
Invasive mechanical ventilation mode
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admission to PICU at the University Children's Hospital Zurich
* Need for mechanical ventilation for \>60 min during PICU hospitalization. Need for mechanical ventilation will be based on clinical decision of the treating physician.
* Need for an arterial line during PICU hospitalization. Need for an arterial line will be based on clinical decision of the treating physician.
* Age \<18 years
* Weight \>2 Kg
Exclusion Criteria
* Cyanotic shunt lesions
* Intracranial hypertension (i.e. traumatic brain injury or patients admitted after neurosurgery)
* Pulmonary hypertension under treatment (i.e sildenafil or inhaled nitric oxide)
* Time from start of invasive mechanical ventilation until time of screening is \> 24 hours
* Previous enrolment in the study in the past 30 days
* Inability of the parents or legal guardians to understand the study due to linguistic or cognitive reasons
0 Years
18 Years
ALL
No
Sponsors
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University Children's Hospital, Zurich
OTHER
Responsible Party
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Principal Investigators
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Rebeca Mozun, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital, Zurich
Locations
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University Children's Hospital Zurich
Zurich, Canton of Zurich, Switzerland
Countries
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References
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Mozun R, Chopard D, Zapf F, Baumann P, Brotschi B, Adam A, Jaeggi V, Bangerter B, Gibbons KS, Burren J, Schlapbach LJ. Comparison of carbon dioxide control during pressure controlled versus pressure-regulated volume controlled ventilation in children (CoCO2): protocol for a pilot digital randomised controlled trial in a quaternary paediatric intensive care unit. BMJ Open. 2025 Jan 11;15(1):e087043. doi: 10.1136/bmjopen-2024-087043.
Other Identifiers
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CoCO2
Identifier Type: -
Identifier Source: org_study_id