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Comparison of Gas Exchange Between Two Invasive Mechanical Ventilation Modes in Children (CoCO2)

Primary Purpose

Respiratory Failure

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Respiratory support a
Respiratory support b
Sponsored by
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Failure focused on measuring Pediatrics, Child, Infant, Mechanical ventilation, Pressure control, Pressure regulated volume control, Randomized controlled trial

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Informed consent provided by the participant or the participant's parents or legal guardians. In case of an emergency situation, a physician who is independent of the research project must be consulted prior to inclusion in order to safeguard the interests of the test subject. 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: Substantial air leaks around the endotracheal tube (>30%) 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Pressure control (PC)

    Pressure regulated volume control (PRVC)

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    Adherence to the allocated ventilation mode among randomized/enrolled participants
    Main feasibility outcome
    Proportion of time spent within the target range of carbon dioxide (normocarbia, defined as carbon dioxide ≥ 35 mmHg or 4.5 kPa and ≤ 45 mmHg or 6 kPa) measured using end-tidal carbon dioxide recorded every minute by the ventilation device
    Main physiological outcome

    Secondary Outcome Measures

    Number of patients who were screened, were missed, gave consent and were randomized/enrolled per month
    Secondary feasibility outcome 1
    Reasons for protocol violations
    Other feasibility outcome 2a
    Time from randomization to protocol violation
    Other feasibility outcome 2b
    Proportion of enrolled participants with complete primary and secondary outcome data extracted from the electronic patient records
    Other feasibility outcome 3
    Time from ventilation start until screening
    Other feasibility outcome 4a
    Time from ventilation start until randomization
    Other feasibility outcome 4b
    Time from consent until randomization
    Other feasibility outcome 5
    Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa), measured using continuous end-tidal carbon dioxide
    Secondary physiological outcome 1a
    Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa) measured using intermittent arterial blood measurements
    Other physiological outcome 1b
    Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa) measured using continuous transcutaneous carbon dioxide measurements calibrated with results of arterial blood gas analysis
    Other physiological outcome 1c
    Time weighted average of hypercarbia (carbon dioxide > 45 mmHg or 6 kPa) measured using continuous end-tidal carbon dioxide
    Other physiological outcome 2a
    Time weighted average of hypercarbia (carbon dioxide >45 mmHg or 6 kPa) measured using intermittent arterial blood measurements
    Other physiological outcome 2b
    Time weighted average of hypercarbia (carbon dioxide > 45 mmHg or 6 kPa) measured using continuous transcutaneous carbon dioxide measurements calibrated with results of arterial blood gas analysis
    Other physiological outcome 2c
    Time weighted average of hypo- and hypercarbia (i.e. outside normocarbia, carbon dioxide < 35 mmHg or 4.5 kPa; or carbon dioxide >45 mmHg or 6 kPa) measured using continuous end-tidal carbon dioxide
    Other physiological outcome 3a
    Time weighted average of hypo- and hypercarbia (i.e. outside normocarbia, carbon dioxide < 35 mmHg or 4.5 kPa; or carbon dioxide >45 mmHg or 6 kPa) measured using intermittent arterial blood measurements
    Other physiological outcome 3b
    Time weighted average of hypo- and hypercarbia (i.e. carbon dioxide < 35 mmHg or 4.5 kPa; or >45 mmHg or 6 kPa) measured using continuous transcutaneous carbon dioxide measurements calibrated with results of arterial blood gas analysis
    Other physiological outcome 3c

    Full Information

    First Posted
    January 24, 2023
    Last Updated
    April 24, 2023
    Sponsor
    University Children's Hospital, Zurich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05843123
    Brief Title
    Comparison of Gas Exchange Between Two Invasive Mechanical Ventilation Modes in Children
    Acronym
    CoCO2
    Official Title
    Comparison of Carbon Dioxide Control During Pressure Controlled (PC) Versus Pressure Regulated Volume Control (PRVC) Ventilation in Children (CoCO2): A Digital, Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Children's Hospital, Zurich

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study assesses the feasibility of digital data collection for a randomized controlled trial in a quaternary pediatric intensive care unit and the effect of two commonly used mechanical ventilation modes on gas exchange (CO2) in children over 2 days after randomization. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Failure
    Keywords
    Pediatrics, Child, Infant, Mechanical ventilation, Pressure control, Pressure regulated volume control, Randomized controlled trial

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a single center, open labelled, randomized controlled trial with one to one allocation to two invasive mechanical ventilation modes used in clinical care as intervention arms
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pressure control (PC)
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Pressure regulated volume control (PRVC)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Respiratory support a
    Other Intervention Name(s)
    "Target Vent" is the brand name of the PRVC ventilation mode in the Bellavista ventilator
    Intervention Description
    Invasive mechanical ventilation mode
    Intervention Type
    Other
    Intervention Name(s)
    Respiratory support b
    Intervention Description
    Invasive mechanical ventilation mode
    Primary Outcome Measure Information:
    Title
    Adherence to the allocated ventilation mode among randomized/enrolled participants
    Description
    Main feasibility outcome
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
    Title
    Proportion of time spent within the target range of carbon dioxide (normocarbia, defined as carbon dioxide ≥ 35 mmHg or 4.5 kPa and ≤ 45 mmHg or 6 kPa) measured using end-tidal carbon dioxide recorded every minute by the ventilation device
    Description
    Main physiological outcome
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
    Secondary Outcome Measure Information:
    Title
    Number of patients who were screened, were missed, gave consent and were randomized/enrolled per month
    Description
    Secondary feasibility outcome 1
    Time Frame
    From date of recruitment start until date of recruitment end (assessed when n=60, anticipated through 6 months of recruitment period)
    Title
    Reasons for protocol violations
    Description
    Other feasibility outcome 2a
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours since randomization)
    Title
    Time from randomization to protocol violation
    Description
    Other feasibility outcome 2b
    Time Frame
    From time of randomization until time of protocol violation (assessed up to 48 hours)
    Title
    Proportion of enrolled participants with complete primary and secondary outcome data extracted from the electronic patient records
    Description
    Other feasibility outcome 3
    Time Frame
    From date of recruitment start until date of study end (assessed when n=60 and data has been extracted for all participants, anticipated through 8 months)
    Title
    Time from ventilation start until screening
    Description
    Other feasibility outcome 4a
    Time Frame
    From time of ventilation start until time of screening (assessed up to 48 hours)
    Title
    Time from ventilation start until randomization
    Description
    Other feasibility outcome 4b
    Time Frame
    From time of ventilation start until time of randomization (assessed up to 48 hours)
    Title
    Time from consent until randomization
    Description
    Other feasibility outcome 5
    Time Frame
    From time of consent signed until time of randomization (assessed up to 48 hours)
    Title
    Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa), measured using continuous end-tidal carbon dioxide
    Description
    Secondary physiological outcome 1a
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
    Title
    Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa) measured using intermittent arterial blood measurements
    Description
    Other physiological outcome 1b
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
    Title
    Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa) measured using continuous transcutaneous carbon dioxide measurements calibrated with results of arterial blood gas analysis
    Description
    Other physiological outcome 1c
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
    Title
    Time weighted average of hypercarbia (carbon dioxide > 45 mmHg or 6 kPa) measured using continuous end-tidal carbon dioxide
    Description
    Other physiological outcome 2a
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
    Title
    Time weighted average of hypercarbia (carbon dioxide >45 mmHg or 6 kPa) measured using intermittent arterial blood measurements
    Description
    Other physiological outcome 2b
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
    Title
    Time weighted average of hypercarbia (carbon dioxide > 45 mmHg or 6 kPa) measured using continuous transcutaneous carbon dioxide measurements calibrated with results of arterial blood gas analysis
    Description
    Other physiological outcome 2c
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
    Title
    Time weighted average of hypo- and hypercarbia (i.e. outside normocarbia, carbon dioxide < 35 mmHg or 4.5 kPa; or carbon dioxide >45 mmHg or 6 kPa) measured using continuous end-tidal carbon dioxide
    Description
    Other physiological outcome 3a
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
    Title
    Time weighted average of hypo- and hypercarbia (i.e. outside normocarbia, carbon dioxide < 35 mmHg or 4.5 kPa; or carbon dioxide >45 mmHg or 6 kPa) measured using intermittent arterial blood measurements
    Description
    Other physiological outcome 3b
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
    Title
    Time weighted average of hypo- and hypercarbia (i.e. carbon dioxide < 35 mmHg or 4.5 kPa; or >45 mmHg or 6 kPa) measured using continuous transcutaneous carbon dioxide measurements calibrated with results of arterial blood gas analysis
    Description
    Other physiological outcome 3c
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
    Other Pre-specified Outcome Measures:
    Title
    Oxygenation index measured using peripheral oxygen saturation index
    Description
    Other physiological outcome 4a (Peripheral oxygen saturation index = MAP * FiO2 *100 / SpO2; where MAP is mean airway pressure, FiO2 is fraction of inspired oxygen, SpO2 is peripheral oxygen saturation)
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
    Title
    Oxygenation index measured using arterial oxygenation index
    Description
    Other physiological outcome 4b (Arterial oxygenation index = MAP * FiO2 *100 / PaO2 ; where MAP is mean airway pressure, FiO2 is fraction of inspired oxygen, PaO2 is partial pressure of oxygen in arterial blood)
    Time Frame
    From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Informed consent provided by the participant or the participant's parents or legal guardians. In case of an emergency situation, a physician who is independent of the research project must be consulted prior to inclusion in order to safeguard the interests of the test subject. 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: Substantial air leaks around the endotracheal tube (>30%) 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rebeca Mozun
    Phone
    +41 44 266 39 37
    Email
    rebeca.mozuntorrico@kispi.uzh.ch
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elisa Zimmermann
    Phone
    +41 44 266 74 08
    Email
    Elisa.Zimmermann@kispi.uzh.ch

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Gas Exchange Between Two Invasive Mechanical Ventilation Modes in Children

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