Evaluation of the role of regional pulmonary hypoperfusion in the development of vintilation induced lung injury

Regional Hypo-perfusion as metabolic raiser of ventilator-induced lung injury (VILI): pilot clinica trial - CO2 inhalation in severe ARDS on ECMO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001294-25-IT

Enrollment

Registered

2019-03-14

Start date

2018-07-26

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Acute Respiratory Distress Syndrome (ARDS) MedDRA version: 20.0 Level: LLT Classification code 10038651 Term: Respiration failure System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: PT Classification code 10001053 Term: Acute respiratory failure System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disor

Interventions

Trade Name: 5% Carbon Dioxide / Oxygen Medical Gas Mixture Pharmaceutical Form: INN or Proposed INN: 5% CO2/95% O2 CAS Number: 8063-77-2 Current Sponsor code: Carbogen Other descriptive name: Carboge

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ARDS diagnosis (according to Berlin definition), deep sedation and neuromuscular paralysis, controlled mechanical ventilation and veno-venous ECMO Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: Age lower than 18 years; hemodynamic instability; active air leakage from the lung; neurologic injury or clinical suspicion of increased intracranial pressure; pregnancy, moribundus status; refusal by the attending physician

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the feasibility and safety of adding inhaled CO2 5% during mechanical ventilation in ARDS patients on ECMO, while preventing changes in arterial CO2 and pH through the increase in extracorporeal CO2 removal by ECMO system. ;Secondary Objective: Safety evaluation of adverse events;Primary end point(s): Primary: To verify the feasibility of adding inhaled CO2 5% without changes in arterial CO2 and pH. i.e. keeping PaCO2 within the range 35-45 mmHg for two consecutive measurememts and during the whole period of observation (60-90 minutes) at least in 8 of 10 patients ;Timepoint(s) of evaluation of this end point: Repeated arterial blood gas analysis at 5-10-20-30-60-90-120 minutes from the beginning of CO2 administration	—

Measure

Time frame

Main Objective: To investigate the feasibility and safety of adding inhaled CO2 5% during mechanical ventilation in ARDS patients on ECMO, while preventing changes in arterial CO2 and pH through the increase in extracorporeal CO2 removal by ECMO system. ;Secondary Objective: Safety evaluation of adverse events;Primary end point(s): Primary: To verify the feasibility of adding inhaled CO2 5% without changes in arterial CO2 and pH. i.e. keeping PaCO2 within the range 35-45 mmHg for two consecutive measurememts and during the whole period of observation (60-90 minutes) at least in 8 of 10 patients ;Timepoint(s) of evaluation of this end point: Repeated arterial blood gas analysis at 5-10-20-30-60-90-120 minutes from the beginning of CO2 administration

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Secondary

Measure	Time frame
Secondary end point(s): Secondary: in order to assess the safety of CO2 administration, the incidence of the following advere events will be recorded: arterial pH < 7.2 in more than two consecutive measurements at least 10 minutes apart; hemodynamic instability with hypotension and hypertension; arrhythmias; pulmonary arterial hypertension ;Timepoint(s) of evaluation of this end point: Monitoring during two hours of trealtment	—

Measure

Time frame

Secondary end point(s): Secondary: in order to assess the safety of CO2 administration, the incidence of the following advere events will be recorded: arterial pH < 7.2 in more than two consecutive measurements at least 10 minutes apart; hemodynamic instability with hypotension and hypertension; arrhythmias; pulmonary arterial hypertension ;Timepoint(s) of evaluation of this end point: Monitoring during two hours of trealtment

—

Countries

Italy

Contacts

Public ContactUOC Rianimazione e Terapia Intensiv

Fondazione IRCCS Ca' Granda Ospedalwe Maggiore Polclinico

tommaso.mauri@policlinico.mi.it0255033293

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026