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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Respiratory Distress Syndrome, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Data analysis will be blinded.

Study Groups

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Conventional lung protective ventilation

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

Group Type ACTIVE_COMPARATOR

Conventional Lung Protective Ventilation

Intervention Type OTHER

Ventilation with 6ml/kg predicted body weight

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

Group Type EXPERIMENTAL

Prismalung

Intervention Type 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.

Ultra-protective ventilation

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

Ultra-protective ventilation

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

Intervention Type OTHER

Conventional Lung Protective Ventilation

Ventilation with 6ml/kg predicted body weight

Intervention Type OTHER

Other Intervention Names

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Low flow extracorporeal carbon dioxide removal Respiratory Dialysis

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No