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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressure control (PC) | Active Comparator | 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) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory support a | Other | Invasive mechanical ventilation mode |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the allocated ventilation mode among randomized/enrolled participants | Main feasibility outcome | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
| 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 | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who were screened, were missed, gave consent and were randomized/enrolled per month | Secondary feasibility outcome 1 | From date of recruitment start until date of recruitment end (assessed when n=60, anticipated through 6 months of recruitment period) |
| Reasons for protocol violations |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation index measured using peripheral oxygen saturation index | 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) | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebeca Mozun, MD PhD | University Children's Hospital, Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Zurich | Zurich | Canton of Zurich | 8032 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39800404 | Derived | 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. |
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The research team will have access to the dataset of this study. Anonymized data could be available upon reasonable request after approval from the research committee and sponsoring institution.
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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
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| Respiratory support b | Other | Invasive mechanical ventilation mode |
|
Other feasibility outcome 2a |
| From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours since randomization) |
| Time from randomization to protocol violation | Other feasibility outcome 2b | From time of randomization until time of protocol violation (assessed up to 48 hours) |
| Proportion of enrolled participants with complete primary and secondary outcome data extracted from the electronic patient records | Other feasibility outcome 3 | 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) |
| Time from ventilation start until screening | Other feasibility outcome 4a | From time of ventilation start until time of screening (assessed up to 48 hours) |
| Time from ventilation start until randomization | Other feasibility outcome 4b | From time of ventilation start until time of randomization (assessed up to 48 hours) |
| Time from consent until randomization | Other feasibility outcome 5 | From time of consent signed until time of randomization (assessed up to 48 hours) |
| Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa), measured using continuous end-tidal carbon dioxide | Secondary physiological outcome 1a | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
| Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa) measured using intermittent arterial blood measurements | Other physiological outcome 1b | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
| 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 | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
| Time weighted average of hypercarbia (carbon dioxide > 45 mmHg or 6 kPa) measured using continuous end-tidal carbon dioxide | Other physiological outcome 2a | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
| Time weighted average of hypercarbia (carbon dioxide >45 mmHg or 6 kPa) measured using intermittent arterial blood measurements | Other physiological outcome 2b | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
| 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 | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
| 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 | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
| 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 | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
| 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 | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |
| Oxygenation index measured using arterial oxygenation index | 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) | From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours) |