Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury

NCT06321497 | Recruiting

• 1 other identifier: 85711
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS, Human

Keywords

ECC2R, Carbon dioxide, ventilator induced lung injury

Outcome Measures

Primary Outcomes (1)

• Reduction in driving airway pressures

  72 and 144 hours post initiation of ECCO2R

Secondary Outcomes (1)

• Reduction in pulmonary inflammation assessed by interleukins in lung

  72 and 144 hours post initiation of ECCO2R

Study Arms (1)

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

Device: Extracorporeal carbon dioxide removal

Interventions

Extracorporeal carbon dioxide removal DEVICE

Low flow extracorporeal carbon dioxide removal with PrismaLung+

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18 years or older) with diagnosis of ARDS

You may qualify if:

• Adult patients (18 years or older) with diagnosis of ARDS as per Berlin Definition21.
• Driving pressure (ΔP) \> 14 and/or Plateau \>/= 25 (ΔP is calculated using as plateau pressure minus positive end-expiratory pressure)20 Respiratory rate \> 20 breaths per minute pH \< 7.25 and PaCO2 \>45

Sponsors & Collaborators

• Peninsula Health: lead
• Monash University: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Frankston Hospital

Frankston, Victoria, 3199, Australia

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• RAVINDRANATH TIRUVOIPATI, PhD

  Peninsula Heatlh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RAVINDRANATH TIRUVOIPATI, PhD

CONTACT

+61431279347; Rtiruvoipati@phcn.vic.gov.au

Sachin Gupta, FCICM

CONTACT

sachingupta@phcn.vic.gov.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: March 20, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)