N/A N=50 Treatment

Extracorporeal Lung Assist to Avoid Intubation in Patients Failing Noninvasive Ventilation for Hypercapnic ARF

Hypercapnia · Respiratory Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT01784367 ↗

Enrolled (actual)

Serious AEs

26.0%

Results posted

Aug 2024

Primary outcome: Primary: Number of Patients With Need for Intubation for Invasive Mechanical Ventilation — 11; 25 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: vv-ECCO2R (Novalung GmbH, Germany) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Need for Intubation for Invasive Mechanical Ventilation	11; 25	—
SECONDARY Length of Non-invasive Ventilation	4.6	—
SECONDARY Complication Rates	11; 2	—
SECONDARY Length of Invasive Mechanical Ventilation if Intubated	8.3; 13.7	—
SECONDARY Length of Stay in ICU	28.9; 24.0	—
SECONDARY Mortality	7; 7	—

Summary

The study´s intention is to evaluate the feasibility, safety and effectiveness of a pump driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid intubation and invasive mechanical ventilation in patients with acute respiratory failure retaining carbon dioxide due to the failure of their ventilatory muscle pump and not responding to prior non-invasive mask ventilation.

Eligibility Criteria

Inclusion Criteria

acute or acute-on-chronic hypercapnic respiratory insufficiency (pH ≤ 7,35, PaCO2 > 45 mmHg)
failure of noninvasive ventilation
fulfilling criteria for endotracheal intubation

Exclusion Criteria

under 18 years of age
prior inclusion in other interventional study
pregnancy
heparin allergy or heparin-induced thrombocytopenia type 2
on home non-invasive ventilator
"Do not resuscitate" order or moribund condition
life expectancy less than 6 months
no informed consent available

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01784367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.