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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032240638

Enrollment

Registered

2025-01-27

Start date

2025-08-03

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

severe acute respiratory failure ARDS

Interventions

A dialysis catheter with combination of a pediatric artificial lung to undergo low-flow extracorporeal circulation.

Ventilators, Mechanical

artificial ventilator

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
(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

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Contacts

Public ContactMumon Takita

St. Marianna University

takitamumon@marianna-u.ac.jp+81-44-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026