Ultra-protective Pulmonary Ventilation Supported by Low Flow ECCO2R for Severe ARDS

NCT02252094 | Terminated

• 1 other identifier: NMRC/TA/0015/2013
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the use of ultra-protective ventilation, where very low ventilation volumes are used, in patients with severe acute respiratory distress syndrome (ARDS) meeting criteria to nurse in the prone position. Half the patients will receive ultra-protective ventilation support by extracorporeal carbon dioxide removal, while the other half will receive conventional lung protective ventilation.

Conditions

Respiratory Distress Syndrome, Adult

Outcome Measures

Primary Outcomes (1)

• Plateau Pressure

  Ability to achieve a plateau pressure of \</=25 cmH20 in the intervention arm

  Duration of ventilation for severe ARDS, expected average time 10 days

Secondary Outcomes (18)

• Length of stay in ICU stay

  Duration of patient stay in ICU, expected average stay 2 weeks

• Length of hospital stay

  Duration of patient stay in hospital

• Mortality

  Monitored for 3 months

• Cardiac Imaging

  One data set per patient during first 72 hours

• Extracorporeal carbon dioxide removal related complications

  Duration of severe ARDS, expected average time frame 10 days

Study Arms (2)

Conventional lung protective ventilation

ACTIVE COMPARATOR

Lung protective ventilation (6ml/kg predicted body weight). All other interventions per intensive care unit standardised ARDS management protocol

Other: Conventional Lung Protective Ventilation

Ultra-protective ventilation

EXPERIMENTAL

Ultra-protective ventilation (\</= 3ml/kg predicted body weight) targeting plateau pressure of \</= 25 cmH2O, supported by Prismalung. All other intervention per intensive care unit standardised ARDS management protocol

Device: Prismalung; Other: Ultra-protective ventilation

Interventions

Prismalung DEVICE

Prism lung (Baxter Healthcare/Gambro Lund, Sweden) is an extracorporeal carbon dioxide removal device. It removes blood through a double lumen catheter and pumps it through a hollow fiber gas exchange cartridge which is impervious to fluid. Carbon dioxide diffuses out, down a concentration gradient which is maintained by sweep gas flowing through the centre of the hollow fibres. The decarboxylated blood is returned to the patient through the double lumen catheter.

Also known as: Low flow extracorporeal carbon dioxide removal, Respiratory Dialysis

Ultra-protective ventilation

Ultra-protective ventilation OTHER

Ventilation with \</= 3ml/kg predicted body weight

Ultra-protective ventilation

Conventional Lung Protective Ventilation OTHER

Ventilation with 6ml/kg predicted body weight

Conventional lung protective ventilation

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to MICU with respiratory failure and intubated
• ARDS criteria per Berlin definition
• PaO2:FiO2 ratio ≤ 200 mmHg for \> 6 hours with FiO2 ≥0.5
• Expected to require mechanical ventilation for \>48 hours
• Reversible disease

You may not qualify if:

• Anticoagulation contraindicated
• Proven HIT
• Unable to obtain central venous access
• Refractory hypoxia (PaO2:FiO2 ≤80 after recruitment and proning) or other indication for ECMO
• Home oxygen use
• Severe COPD
• Interstitial lung disease
• \> 7 days of mechanical ventilation
• Immunocompromised patient (bone marrow, untreated HIV, PJP)
• Advanced malignancy with life expectancy ≤ 6months

Sponsors & Collaborators

• National University Health System, Singapore: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (2)

National University Hospital

Singapore, 119074, Singapore

Location

Ng Teng Fong General Hospital

Singapore, 609606, Singapore

Location

Related Publications (2)

• Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2.

  PMID: 19741487 BACKGROUND

• Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.

  PMID: 23306584 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Matthew E Cove, MBChB

  National University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysis will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Matthew COVE

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 29, 2014
• Study Start: May 22, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)