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

Not Applicable

Terminated

• Conditions: Respiratory Distress Syndrome, Adult
• Interventions: Other: Conventional Lung Protective Ventilation; Device: Prismalung; Other: Ultra-protective ventilation

• Registration Number: NCT02252094
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-29
• Study Start: 2017-05-22
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional lung protective ventilation	Conventional Lung Protective Ventilation	Lung protective ventilation (6ml/kg predicted body weight). All other interventions per intensive care unit standardised ARDS management protocol
Ultra-protective ventilation	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
Ultra-protective ventilation	Prismalung	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

Primary Outcome Measures

Name	Time	Method
Plateau Pressure	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

Name	Time	Method
Enrolment rates	First 48 hours
Barotrauma complications	Duration of ICU stay
Incidence of dialysis in ICU, and ability to successfully initiate	Duration of ICU stay
Length of hospital stay	Duration of patient stay in hospital
Cardiac Imaging	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
Ability to successfully prone	Duration of ICU stay
Mortality	Monitored for 3 months	ICU mortality, hospital mortality, 30 day, 60 day and 90 day mortality
Extracorporeal carbon dioxide removal related complications	Duration of severe ARDS, expected average time frame 10 days	Complications or adverse events related to ECCO2R and associated anticoagulation
Ventilator free days	28 days
Ventilation parameters	Duration of mechanical ventilation	Data download from mechanical ventilation
Ventilator associated pneumonia rates	Duration of ICU stay
Number of patient meeting proning criteria in each group	Duration of ICU stay
Lung recruitability	Duration of ICU stay
Length of stay in ICU stay	Duration of patient stay in ICU, expected average stay 2 weeks
Biomarkers of Pulmonary Inflammation	Day 0, 4 and 7	Serum will be drawn and stored for pulmonary biomarkers analysis at the above time points
All severe adverse events	Duration of ICU stay (anticipate average stay 1-2 weeks)
Incidence of referrals for ECMO	Duration of ICU stay
Rate and reasons for declining consent to study participation	First 48 hours

Trial Locations

Locations (2)

National University Hospital; 🇸🇬 Singapore, Singapore

Ng Teng Fong General Hospital; 🇸🇬 Singapore, Singapore