Strategy of Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for New-Onset Moderate ARDS: A Prospective Multicenter Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Acute respiratory distress syndrome (ARDS) accounts for 10% of all ICU admissions and for 23% of patients requiring mechanical ventilation (MV). Its hospital mortality remains high, ranging from 34% in mild forms up to 46% in severe cases. Positive pressure MV remains the cornerstone of management, but at the same time it can contribute to worsening and maintenance of the lung injury when excessive stress and strain is applied to the lung parenchima (so-called ventilator-induced lung injury, VILI). VILI significantly contributes to the morbidity and mortality of ARDS patients, and it has been clearly demonstrated that protective (low-volume, low-pressure) MV settings are associated with a significant survival benefit. Unfortunately, in a certain proportion of ARDS cases, it is difficult to preserve acceptable gas exchange while maintaining protective ventilation settings, due to a high ventilatory load. In these cases, extracorporeal CO2 removal (ECCO2R) can be applied to grant the application of protective or even ultra-protective mechanical ventilation settings. The main outcome of this multicenter, prospective, randomized, comparative open trial is to determine whether early ECCO2R allowing ultraprotective mechanical ventilation improves the outcomes of patients with moderate ARDS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Age ≥ 18 years

• On invasive mechanical ventilation for ≤ 96 hours

• Presence of all of the following conditions for ≤ 24 hours: 100 \< PaO2/FiO2 ≤ 200 after 12 hours of standardized ventilation with PEEP ≥ 5; compliance of the respiratory system ≤ 0.5 ml/cmH2O per kg PBW; ventilatory ratio (VR) ≥ 1.5; bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules; respiratory failure not fully explained by cardiac failure or fluid overload

Locations
Other Locations
Italy
IRCCS AOUBO Policlinico di Sant'Orsola
RECRUITING
Bologna
Contact Information
Primary
Tommaso Tonetti, M.D.
tommaso.tonetti@unibo.it
+39-0512143268
Backup
Marco Ranieri, M.D.
m.ranieri@unibo.it
+39-0512143268
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 230
Treatments
Experimental: ECCO2R
Patients will be initially treated with standardized ventilation: volume assist/control, VT = 6 mL/kg PBW; insp. flow 50-70 L/min, I:E ratio 1:1 to 1:3; RR 20-35 bpm; PEEP according to low PEEP/ high FiO2 table. Goals: PaO2 55-80 mmHg or SpO2 88-95%; arterial pH: 7.30-7.45.~ECCO2R initiated during standardized ventilation with blood flow between 1000 and 1500 mL/min. Anticoagulation with unfractionated heparin to a target aPTT of 1.5-2.0x baseline. Target: maintain PaCO2 at baseline ± 20%.~VT initially reduced to 5 mL/kg. Sweep gas initiated and VT decreased to 4.5 then 4 mL/kg; PEEP adjusted to maintain same mean airway pressure as during standardized ventilation, provided that Pplat ≤ 25 cmH2O.~Respiratory rate decreased to 8 bpm. If PaCO2 \> 75 mmHg and/or pH \< 7.2, despite respiratory rate of 35/min and optimized ECCO2R, VT will be increased to the last previously tolerated VT.~Recommendation: 2 daily lung recruitment maneuvers (as per clinical practice in each center).
Active_comparator: Standard of care
Patients will be treated with standardized ventilation: volume assist/control, VT = 6 mL/kg PBW; insp. flow 50-70 L/min, I:E ratio 1:1 to 1:3; RR 20-35 bpm; PEEP according to low PEEP/ high FiO2 table. Goals: PaO2 55-80 mmHg or SpO2 88-95%; arterial pH: 7.30-7.45.~Recommendation: 2 daily lung recruitment maneuvers (as per clinical practice in each center).
Sponsors
Collaborators: Getinge Group
Leads: University of Bologna

This content was sourced from clinicaltrials.gov