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

Sponsor

University Children's Hospital, Zurich (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05843123

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure	Other: Respiratory support a Other: Respiratory support b	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 armsThis 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)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Other: Respiratory support b Invasive mechanical ventilation mode
Active Comparator: 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.	Other: Respiratory support a Invasive mechanical ventilation mode Other Names: "Target Vent" is the brand name of the PRVC ventilation mode in the Bellavista ventilator

Arm

Intervention/Treatment

Active Comparator: 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

Other: Respiratory support b

Invasive mechanical ventilation mode

Active Comparator: 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.

Other: Respiratory support a

Invasive mechanical ventilation mode

Other Names:

"Target Vent" is the brand name of the PRVC ventilation mode in the Bellavista ventilator

Outcome Measures

Primary Outcome Measures

Adherence to the allocated ventilation mode among randomized/enrolled participants [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
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 [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
Main physiological outcome

Secondary Outcome Measures

Number of patients who were screened, were missed, gave consent and were randomized/enrolled per month [From date of recruitment start until date of recruitment end (assessed when n=60, anticipated through 6 months of recruitment period)]
Secondary feasibility outcome 1
Reasons for protocol violations [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours since randomization)]
Other feasibility outcome 2a
Time from randomization to protocol violation [From time of randomization until time of protocol violation (assessed up to 48 hours)]
Other feasibility outcome 2b
Proportion of enrolled participants with complete primary and secondary outcome data extracted from the electronic patient records [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)]
Other feasibility outcome 3
Time from ventilation start until screening [From time of ventilation start until time of screening (assessed up to 48 hours)]
Other feasibility outcome 4a
Time from ventilation start until randomization [From time of ventilation start until time of randomization (assessed up to 48 hours)]
Other feasibility outcome 4b
Time from consent until randomization [From time of consent signed until time of randomization (assessed up to 48 hours)]
Other feasibility outcome 5
Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa), measured using continuous end-tidal carbon dioxide [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
Secondary physiological outcome 1a
Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa) measured using intermittent arterial blood measurements [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
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 [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
Other physiological outcome 1c
Time weighted average of hypercarbia (carbon dioxide > 45 mmHg or 6 kPa) measured using continuous end-tidal carbon dioxide [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
Other physiological outcome 2a
Time weighted average of hypercarbia (carbon dioxide >45 mmHg or 6 kPa) measured using intermittent arterial blood measurements [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
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 [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
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 [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
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 [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
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 [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
Other physiological outcome 3c

Other Outcome Measures

Oxygenation index measured using peripheral oxygen saturation index [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
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)
Oxygenation index measured using arterial oxygenation index [From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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