Respiratory FailurePhase 4CoCO2NCT05843123
Comparison of Gas Exchange Between Two Invasive Mechanical Ventilation Modes in Children
A Phase 4 study testing Respiratory support a and Respiratory support b in people with Respiratory Failure, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Respiratory support a and Respiratory support b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jan 2024to 20 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Zurich
Zurich, Canton of Zurich, 8032
About this study
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
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.
- Conditions
- Respiratory Failure
- Being tested
- Respiratory support a, Respiratory support b
- Keywords
- Pediatrics, Child, Infant, Mechanical ventilation, Pressure control, Pressure regulated volume control, Randomized controlled trial
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory support aOther
Also called "Target Vent" is the brand name of the PRVC ventilation mode in the Bellavista ventilator
Invasive mechanical ventilation mode
Respiratory support bOther
Invasive mechanical ventilation mode
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Respiratory support b |
| 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. Receives: Other: Respiratory support a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the allocated ventilation mode among randomized/enrolled participants
Main feasibility outcome
Measured: 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
Measured: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
Secondary outcomes (16)
Number of patients who were screened, were missed, gave consent and were randomized/enrolled per month
Secondary feasibility outcome 1
Measured: 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
Other feasibility outcome 2a
Measured: 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
Measured: 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
Measured: 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
Measured: From time of ventilation start until time of screening (assessed up to 48 hours)
Time from ventilation start until randomization
Other feasibility outcome 4b
Measured: From time of ventilation start until time of randomization (assessed up to 48 hours)
Time from consent until randomization
Other feasibility outcome 5
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Jan 2024
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebeca Mozun, MD PhD, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843123
- Sponsor's protocol ID
- CoCO2
- Acronym
- CoCO2
- Status last verified
- Dec 2024
- First submitted
- 24 Jan 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 39800404
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05843123
- Acronym / sponsor ID
- CoCO2 / CoCO2
- Conditions
- Respiratory Failure
- Keywords
- Pediatrics, Child, Infant, Mechanical ventilation, Pressure control, Pressure regulated volume control, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Pressure control (PC) | Active comparator | Other: Respiratory support bIn 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 | Other: Respiratory support aIn 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. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory support aAlso: "Target Vent" is the brand name of the PRVC ventilation mode in the Bellavista ventilatorInvasive mechanical ventilation mode | Other | Pressure regulated volume control (PRVC) |
| Respiratory support bInvasive mechanical ventilation mode | Other | Pressure control (PC) |
Primary outcome
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
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
16 secondary outcomes
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)
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)
Time from randomization to protocol violation
Time frame: 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
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)
Time from ventilation start until screening
Time frame: From time of ventilation start until time of screening (assessed up to 48 hours)
Time from ventilation start until randomization
Time frame: From time of ventilation start until time of randomization (assessed up to 48 hours)
Time from consent until randomization
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From time of randomization until 48 hours, extubation, discharge or death, whichever comes first (assessed up to 48 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Derived from this study: PubMed 39800404Mozun 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebeca Mozun, MD PhD principal investigator
University Children's Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Respiratory support a and Respiratory support b in people with Respiratory Failure, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05843123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.