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Completed

NCT Number: NCT05843123

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

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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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Children's Hospital Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory support a

Other

Invasive mechanical ventilation mode

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

Respiratory support b

Other

Invasive mechanical ventilation mode

Primary outcomes

  1. Adherence to the allocated ventilation mode among randomized/enrolled participants

    Time frame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)

    Main feasibility outcome

  2. 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

    Time frame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)

    Main physiological outcome

Secondary outcomes

  1. Number of patients who were screened, were missed, gave consent and were randomized/enrolled per month

    Time frame: 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

  2. Reasons for protocol violations

    Time frame: 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

  3. Time from randomization to protocol violation

    Time frame: From time of randomization until time of protocol violation (assessed up to 48 hours)

    Other feasibility outcome 2b

  4. Proportion of enrolled participants with complete primary and secondary outcome data extracted from the electronic patient records

    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)

    Other feasibility outcome 3

  5. Time from ventilation start until screening

    Time frame: From time of ventilation start until time of screening (assessed up to 48 hours)

    Other feasibility outcome 4a

  6. Time from ventilation start until randomization

    Time frame: From time of ventilation start until time of randomization (assessed up to 48 hours)

    Other feasibility outcome 4b

  7. Time from consent until randomization

    Time frame: From time of consent signed until time of randomization (assessed up to 48 hours)

    Other feasibility outcome 5

  8. Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa), measured using continuous end-tidal carbon dioxide

    Time frame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)

    Secondary physiological outcome 1a

  9. Time weighted average of hypocarbia (carbon dioxide < 35 mmHg or 4.5 kPa) measured using intermittent arterial blood measurements

    Time frame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)

    Other physiological outcome 1b

  10. 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

    Time frame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)

    Other physiological outcome 1c

  11. Time weighted average of hypercarbia (carbon dioxide > 45 mmHg or 6 kPa) measured using continuous end-tidal carbon dioxide

    Time frame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)

    Other physiological outcome 2a

  12. Time weighted average of hypercarbia (carbon dioxide >45 mmHg or 6 kPa) measured using intermittent arterial blood measurements

    Time frame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)

    Other physiological outcome 2b

  13. 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

    Time frame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)

    Other physiological outcome 2c

  14. 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

    Time frame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)

    Other physiological outcome 3a

  15. 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

    Time frame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)

    Other physiological outcome 3b

  16. 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

    Time frame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)

    Other physiological outcome 3c

Other outcomes

  1. Oxygenation index measured using peripheral oxygen saturation index

    Time frame: 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)

  2. Oxygenation index measured using arterial oxygenation index

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study 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

Acronym: CoCO2

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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