Clinical trial NCT05843123: Comparison of Gas Exchange Between Two Invasive Mechanical Ventilation Modes in Children
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Failure
Keywords: Pediatrics
Child
Infant
Mechanical ventilation
Pressure control
Pressure regulated volume control
Randomized controlled trial
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 59
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 arms
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Adherence to the allocated ventilation mode among randomized/enrolled participants
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
measure: 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
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
Secondary outcomes:
measure: Number of patients who were screened, were missed, gave consent and were randomized/enrolled per month
timeFrame: From date of recruitment start until date of recruitment end (assessed when n=60, anticipated through 6 months of recruitment period)
measure: Reasons for protocol violations
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours since randomization)
measure: Time from randomization to protocol violation
timeFrame: From time of randomization until time of protocol violation (assessed up to 48 hours)
measure: Proportion of enrolled participants with complete primary and secondary outcome data extracted from the electronic patient records
timeFrame: 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)
measure: Time from ventilation start until screening
timeFrame: From time of ventilation start until time of screening (assessed up to 48 hours)
measure: Time from ventilation start until randomization
timeFrame: From time of ventilation start until time of randomization (assessed up to 48 hours)
measure: Time from consent until randomization
timeFrame: From time of consent signed until time of randomization (assessed up to 48 hours)
measure: Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa), measured using continuous end-tidal carbon dioxide
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
measure: Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa) measured using intermittent arterial blood measurements
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
measure: 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
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
measure: Time weighted average of hypercarbia (carbon dioxide > 45 mmHg or 6 kPa) measured using continuous end-tidal carbon dioxide
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
measure: Time weighted average of hypercarbia (carbon dioxide >45 mmHg or 6 kPa) measured using intermittent arterial blood measurements
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
measure: 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
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
measure: 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
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
measure: 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
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
measure: 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
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
Other outcomes:
measure: Oxygenation index measured using peripheral oxygen saturation index
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
measure: Oxygenation index measured using arterial oxygenation index
timeFrame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Rebeca Mozun, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: