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

NCT05843123 | Completed Phase 4

• 1 other identifier: CoCO2
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Pediatrics; Child; Infant; Mechanical ventilation; Pressure control; Pressure regulated volume control; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (16)

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

  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

  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

  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

  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

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

Other Outcomes (2)

• Oxygenation index measured using peripheral oxygen saturation index

  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

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

Study Arms (2)

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

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.

Other: Respiratory support a

Interventions

Respiratory support a OTHER

Invasive mechanical ventilation mode

Also known as: "Target Vent" is the brand name of the PRVC ventilation mode in the Bellavista ventilator

Pressure regulated volume control (PRVC)

Respiratory support b OTHER

Invasive mechanical ventilation mode

Pressure control (PC)

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 39800404 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Rebeca Mozun, MD PhD

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: May 6, 2023
• Study Start: January 15, 2024
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

CH (1)