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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06321497




Registration number
NCT06321497
Ethics application status
Date submitted
13/03/2024
Date registered
20/03/2024
Date last updated
20/03/2024

Titles & IDs
Public title
Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury
Scientific title
Measuring the Impact of Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury in Mechanically Ventilated Patients
Secondary ID [1] 0 0
85711
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ARDS, Human 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Extracorporeal carbon dioxide removal

Adult patients (18 years or older) with diagnosis of ARDS as per Berlin Definition -


Treatment: Devices: Extracorporeal carbon dioxide removal
Low flow extracorporeal carbon dioxide removal with PrismaLung+
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in driving airway pressures
Timepoint [1] 0 0
72 and 144 hours post initiation of ECCO2R
Secondary outcome [1] 0 0
Reduction in pulmonary inflammation assessed by interleukins in lung
Timepoint [1] 0 0
72 and 144 hours post initiation of ECCO2R

Eligibility
Key inclusion criteria
Adult patients (18 years or older) with diagnosis of ARDS as per Berlin Definition21.

Driving pressure (?P) > 14 and/or Plateau >/= 25 (?P is calculated using as plateau pressure minus positive end-expiratory pressure)20 Respiratory rate > 20 breaths per minute pH < 7.25 and PaCO2 >45
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ARDS lasting more than 72 hours at the time of inclusion High pressure (Plateau pressure >30 cm H2O) or high FiO2 (>0·8) ventilation for more than 168 h (7 days); Life threatening hemodynamic instability as defined by ongoing arrhythmias that is not responsive to treatment Contraindication to limited anticoagulation Treatment limitation including not for resuscitation and not for reintubation Patients with potentially irreversible respiratory failure caused by conditions such as pulmonary fibrosis.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2028
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 0 0
3199 - Frankston

Funding & Sponsors
Primary sponsor type
Government body
Name
Peninsula Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Baxter Healthcare Corporation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Lung protective ventilation with low tidal volumes and low driving pressure are known to reduce mortality in mechanically ventilated patients with acute respiratory failure. This reduction in mortality is known be due to reduction of ventilator induced lung injury that occurs due to high tidal volumes and high driving pressure. When receiving such mechanical ventilation, some patients develop hypercapnia and associated hypercapnic acidosis. Such patients have an increased risk of mortality. While the exact reasons for such increase in mortality is not known, it is recommended to minimise hypercapnia and hypercapnic acidosis during lung protective ventilation. Minimally invasive extracorporeal carbon dioxide removal (ECCO2R) devices are shown to reduce hypercapnia and hypercapnic acidosis. There are several devices that are currently available in the current clinical practice. However, the effect of these devices on reduction in ventilator induced lung injury is not clearly demonstrated. This study aims to assess the use of an ECCO2R device called Prismalung in reducing ventilator induced lung injury. PrismaLung is currently used in our intensive care unit. This assessment is done by measuring interleukins in bronchoalveolar lavage fluid and blood interleukin levels as well as clinical assessment including the reduction of driving pressure.
Trial website
https://clinicaltrials.gov/study/NCT06321497
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
RAVINDRANATH TIRUVOIPATI, PhD
Address 0 0
Peninsula Heatlh
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
RAVINDRANATH TIRUVOIPATI, PhD
Address 0 0
Country 0 0
Phone 0 0
+61431279347
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06321497