An exploratory study on whether low-flow extracorporeal circulation using a dialysis catheter can Improve respiratory acidosis.

JRCT ID: jRCTs032240638

Registered date:27/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: severe acute respiratory failure
• Date of first enrollment: 27/01/2025
• Target sample size: 5
• Study type: Interventional
• Intervention(s): A dialysis catheter with combination of a pediatric artificial lung to undergo low-flow extracorporeal circulation.

Outcome(s)

• Primary Outcome: (1)Artery blood gas values before and after the intervention (Arterial blood gas values on the patient side, blood gas values in the circuit side before and after the artificial lung)

Secondary Outcome

(1) Focus on ventilator settings before and after the intervention, including tidal volume, minute ventilation, peak airway pressure (Ppeak), plateau pressure (Pplat), and driving pressure (Pplat - PEEP)
(2) Circuit pressure, presence of blood clots in the circuit, and blood gas values in the circuit before and after the artificial lung
(3) If spontaneous breathing is observed, measure P0.1, Negative Inspiratory Force Index (NIF), or the pressure difference (PES) between inspiratory and expiratory phases of esophageal pressure (Pes).
(4) Presence or absence of ICU survival discharge
(5) Length of ICU stay
(6) 28 days mortality rate after device removal

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Men and women age equal and greater than 18 years old at the time of registration
(2) Patients with ARDS under mechanical ventilation in the ICU
(3) The study targets patients who have severe respiratory acidosis (pH below 7.25) that prevents the safe implementation of lung-protective ventilation (restricting tidal volume to 6 ml/kg) and who do not meet the criteria for ECMO introduction( PaO2/FiO2 ratio less than 50 for more than 3 hours from after initiating ventilator, PaO2/FiO2 ratio less than 80 for more than 6 hours after initiating ventilator, pH less than 7.25 and PaCO2 over 60 mmHg for more than 6 hours after initiating appropriate ventilator settings).
(4) Patients who can provide written consent for participation in this study, or patients whose legal surrogate can provide written consent.

Exclude criteria

(1) Patients deemed unsuitable as subjects based on the physician's judgment
(2) Patients expected to die within 1 week

Related Information

• Primary Sponsor: Takita Mumon
• Source(s) of Monetary Support: Japan Society for the Promotion of Science