Novel ECCO2R Device for Hypercapnic Respiratory Failure

Launched by UNIVERSITY OF ZURICH · Mar 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Prismalung+ membrane, which aims to help patients with a condition known as hypercapnic respiratory failure. This condition occurs when there is too much carbon dioxide in the blood, making it hard for patients to breathe properly. The trial is looking to see if this device can safely reduce the work of breathing, help patients breathe on their own, and possibly prevent the need for a more intensive treatment called vv-ECMO, which is a type of life support.

To participate in this trial, patients must be between the ages of 65 to 74 and either on a ventilator due to severe breathing difficulties or awake but struggling to breathe. They need to have signed consent to join the study. However, some patients won't be eligible, such as those who need the vv-ECMO treatment right away, are under 18, pregnant, or have certain medical conditions. If eligible, participants will be monitored closely while using the new device to evaluate its effectiveness and safety. This trial is currently recruiting participants, and it offers a chance to be part of important research that could improve care for people with similar breathing issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Mechanically ventilated patient: (I) Progressive respiratory failure (pH≤7.25 and/ or PaCO2 ≥9 kPa) during mechanical ventilation (II) with an inability to maintain lung protective ventilation (VT\<4 mL/kg, Ppeak \<30 mbar, Driving Pressure ≤12 mbar)
• • OR awake spontaneously breathing patient: Respiratory exhaustion (pH≤7.25 and/or PaCO2 ≥9 kPa)
• • AND Informed Consent as documented by signature
• Exclusion Criteria:
• • Mechanical Ventilation group: Need for v-v ECMO
• • Awake spontaneously breathing group: Need for mechanical ventilation due to inability to remain un-sedated
• • Thrombocytopenia (\<100G/l)
• • Contraindications for Heparin therapy (history of heparin antibodies, previous history of intracranial bleeding)
• • Patients under 18 years of age
• • Women who are pregnant or breast feeding
• • Previous enrolment into the current study
• • Enrolment of the investigator, his/her family members, employees and other dependent persons