Comparison of Gas Exchange Between Two Invasive Mechanical Ventilation Modes in Children (CoCO2)

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Respiratory Failure

Treatments: Other: Respiratory support a; Other: Respiratory support b

Study type: Interventional

Funder types: Other

Identifiers

NCT05843123

CoCO2

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Pressure control (PC)

Active Comparator group

Description:

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

Treatment:

Other: Respiratory support b

Pressure regulated volume control (PRVC)

Active Comparator group

Description:

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.

Treatment:

Other: Respiratory support a