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Ultra-protective Pulmonary Ventilation Supported by Low Flow ECCO2R for Severe ARDS (U-Protect)

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ClinicalTrials.gov Identifier: NCT02252094
Recruitment Status : Recruiting
First Posted : September 29, 2014
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Matthew COVE, National University Health System, Singapore

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Device: Prismalung Other: Ultra-protective ventilation Other: Conventional Lung Protective Ventilation Not Applicable

Detailed Description:

Current best practices for management of severe ARDS include lung protective ventilation and nursing in the prone position. However, the best lung protective strategy is not currently established and using smaller ventilation volumes than standard lung protective ventilation suggest lung recovery is improved.

Application of smaller ventilation volumes requires extracorporeal carbon dioxide removal, using a device similar to a dialysis to remove carbon dioxide directly from the blood. One such device in the Prismalung, it removes blood through a catheter, much like a dialysis catheter, pumps it through a gas exchange cartridge which removes carbon dioxide. The gas exchange cartridge functions in a similar way to a dialysis filter, except it allow gases to pass through, unlike dialysis filters which allow passage of fluid and small molecules.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Data analysis will be blinded.
Primary Purpose: Treatment
Official Title: Ultra-protective Pulmonary Ventilation Supported by Low Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) and Prone Positioning for ARDS; a Pilot Study.
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 30, 2020


Arm Intervention/treatment
Active Comparator: Conventional lung protective ventilation
Lung protective ventilation (6ml/kg predicted body weight). All other interventions per intensive care unit standardised ARDS management protocol
Other: Conventional Lung Protective Ventilation
Ventilation with 6ml/kg predicted body weight

Experimental: Ultra-protective ventilation
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
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.
Other Names:
  • Low flow extracorporeal carbon dioxide removal
  • Respiratory Dialysis

Other: Ultra-protective ventilation
Ventilation with </= 3ml/kg predicted body weight




Primary Outcome Measures :
  1. Plateau Pressure [ Time Frame: Duration of ventilation for severe ARDS, expected average time 10 days ]
    Ability to achieve a plateau pressure of </=25 cmH20 in the intervention arm


Secondary Outcome Measures :
  1. Length of stay in ICU stay [ Time Frame: Duration of patient stay in ICU, expected average stay 2 weeks ]
  2. Length of hospital stay [ Time Frame: Duration of patient stay in hospital ]
  3. Mortality [ Time Frame: Monitored for 3 months ]
    ICU mortality, hospital mortality, 30 day, 60 day and 90 day mortality

  4. Cardiac Imaging [ Time Frame: One data set per patient during first 72 hours ]
    Echocardiogram data will be collected before prone position, after prone positioning and following initiation of ultra-protective ventilation

  5. Extracorporeal carbon dioxide removal related complications [ Time Frame: Duration of severe ARDS, expected average time frame 10 days ]
    Complications or adverse events related to ECCO2R and associated anticoagulation

  6. Ventilator free days [ Time Frame: 28 days ]
  7. All severe adverse events [ Time Frame: Duration of ICU stay (anticipate average stay 1-2 weeks) ]
  8. Number of patient meeting proning criteria in each group [ Time Frame: Duration of ICU stay ]
  9. Ability to successfully prone [ Time Frame: Duration of ICU stay ]
  10. Incidence of dialysis in ICU, and ability to successfully initiate [ Time Frame: Duration of ICU stay ]
  11. Incidence of referrals for ECMO [ Time Frame: Duration of ICU stay ]
  12. Rate and reasons for declining consent to study participation [ Time Frame: First 48 hours ]
  13. Enrolment rates [ Time Frame: First 48 hours ]
  14. Lung recruitability [ Time Frame: Duration of ICU stay ]
  15. Ventilation parameters [ Time Frame: Duration of mechanical ventilation ]
    Data download from mechanical ventilation

  16. Ventilator associated pneumonia rates [ Time Frame: Duration of ICU stay ]
  17. Barotrauma complications [ Time Frame: Duration of ICU stay ]
  18. Biomarkers of Pulmonary Inflammation [ Time Frame: Day 0, 4 and 7 ]
    Serum will be drawn and stored for pulmonary biomarkers analysis at the above time points



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252094


Contacts
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Contact: Matthew E Cove, MBChB +65 6772 7678 mdcmec@nus.edu.sg
Contact: Rinky Puri, MSc +65 6779 5555 mdcrpp@nus.edu.sg

Locations
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Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Sub-Investigator: Jason Phua, MBBS         
Sub-Investigator: Amartya Mukherjee, MBBS         
Ng Teng Fong General Hospital Not yet recruiting
Singapore, Singapore, 609606
Contact: Faheem Kahn, MBChB    6716 2000    Faheem_Ahmed_Khan@juronghealth.com.sg   
Contact: Chee Keat Tan, MBBS    6716 2000    chee_keat_tan@juronghealth.com.sg   
Sponsors and Collaborators
National University Health System, Singapore
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Matthew E Cove, MBChB National University Health System

Publications:
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Responsible Party: Matthew COVE, National University Health System, Singapore
ClinicalTrials.gov Identifier: NCT02252094     History of Changes
Other Study ID Numbers: NMRC/TA/0015/2013
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury