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

Respiratory Distress Syndrome, Adult Clinical Trial

— U-Protect  

Official title:

Ultra-protective Pulmonary Ventilation Supported by Low Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) and Prone Positioning for ARDS; a Pilot Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02252094
• Other study ID #: NMRC/TA/0015/2013
• Status: Terminated
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: September 2020
• Source: National University Health System, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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:
• Ultra-protective ventilation
Ventilation with </= 3ml/kg predicted body weight
• Conventional Lung Protective Ventilation
Ventilation with 6ml/kg predicted body weight

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore
Singapore	Ng Teng Fong General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Health System, Singapore	Baxter Healthcare Corporation

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Bein T, Weber-Carstens S, Goldmann A, Müller 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 (˜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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plateau Pressure	Ability to achieve a plateau pressure of	Duration of ventilation for severe ARDS, expected average time 10 days
Secondary	Length of stay in ICU stay		Duration of patient stay in ICU, expected average stay 2 weeks
Secondary	Length of hospital stay		Duration of patient stay in hospital
Secondary	Mortality	ICU mortality, hospital mortality, 30 day, 60 day and 90 day mortality	Monitored for 3 months
Secondary	Cardiac Imaging	Echocardiogram data will be collected before prone position, after prone positioning and following initiation of ultra-protective ventilation	One data set per patient during first 72 hours
Secondary	Extracorporeal carbon dioxide removal related complications	Complications or adverse events related to ECCO2R and associated anticoagulation	Duration of severe ARDS, expected average time frame 10 days
Secondary	Ventilator free days		28 days
Secondary	All severe adverse events		Duration of ICU stay (anticipate average stay 1-2 weeks)
Secondary	Number of patient meeting proning criteria in each group		Duration of ICU stay
Secondary	Ability to successfully prone		Duration of ICU stay
Secondary	Incidence of dialysis in ICU, and ability to successfully initiate		Duration of ICU stay
Secondary	Incidence of referrals for ECMO		Duration of ICU stay
Secondary	Rate and reasons for declining consent to study participation		First 48 hours
Secondary	Enrolment rates		First 48 hours
Secondary	Lung recruitability		Duration of ICU stay
Secondary	Ventilation parameters	Data download from mechanical ventilation	Duration of mechanical ventilation
Secondary	Ventilator associated pneumonia rates		Duration of ICU stay
Secondary	Barotrauma complications		Duration of ICU stay
Secondary	Biomarkers of Pulmonary Inflammation	Serum will be drawn and stored for pulmonary biomarkers analysis at the above time points	Day 0, 4 and 7