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

University Children's Hospital, Zurich59 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Respiratory Failure

Interventions

Eligibility

Sex: ALLMin age: 0 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adherence to the allocated ventilation mode among randomized/enrolled participants

Main feasibility outcome

Time frame: 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

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

Secondary Outcomes

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

Secondary feasibility outcome 1

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

Other feasibility outcome 2a

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

Other feasibility outcome 2b

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

Other feasibility outcome 3

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

Other feasibility outcome 4a

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

Time from ventilation start until randomization

Other feasibility outcome 4b

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

Time from consent until randomization

Other feasibility outcome 5

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

Secondary physiological outcome 1a

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

Other physiological outcome 1b

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

Other physiological outcome 1c

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

Other physiological outcome 2a

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

Other physiological outcome 2b

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

Other physiological outcome 2c

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

Other physiological outcome 3a

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

Other physiological outcome 3b

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

Other physiological outcome 3c

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes