Completed

CoCO2Comparison of Carbon Dioxide Control During Pressure Controlled (PC) Versus Pressure Regulated Volume Control (PRVC) Ventilation in Children (CoCO2): a Digital, Randomized Controlled Trial

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What is being tested

Respiratory support a

+ Respiratory support b

Other
Who is being recruted

Respiration Disorders

+ Respiratory Insufficiency

+ Respiratory Tract Diseases

Until 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 4
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorUniversity Children's Hospital, Zurich
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 15, 2024

Actual date on which the first participant was enrolled.

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.

Official TitleComparison of Carbon Dioxide Control During Pressure Controlled (PC) Versus Pressure Regulated Volume Control (PRVC) Ventilation in Children (CoCO2): a Digital, Randomized Controlled Trial
NCT05843123
Principal SponsorUniversity Children's Hospital, Zurich
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

59 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Respiration DisordersRespiratory InsufficiencyRespiratory Tract Diseases

Criteria

6 inclusion criteria required to participate
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.
Show More Criteria
7 exclusion criteria prevent from participating
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)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University Children's Hospital Zurich

Zurich, SwitzerlandOpen University Children's Hospital Zurich in Google Maps
CompletedOne Study Center