Comparison of Gas Exchange Between Two Invasive Mechanical Ventilation Modes in Children
Phase 4
Completed
- Conditions
- Respiratory Failure
- Interventions
- Other: Respiratory support bOther: Respiratory support a
- Registration Number
- NCT05843123
- Lead Sponsor
- University Children's Hospital, Zurich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pressure control (PC) Respiratory support b 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 Pressure regulated volume control (PRVC) Respiratory support a 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Time from ventilation start until screening From time of ventilation start until time of screening (assessed up to 48 hours) Other feasibility outcome 4a
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
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
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
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 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 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 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 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 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. 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
Trial Locations
- Locations (1)
University Children's Hospital Zurich
🇨🇭Zürich, Switzerland