Changes in Spontaneous Ventilation in Response to Changes in Extracorporeal Carbon Dioxide Removal

Study Overview
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Brief Summary
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In physiological conditions, spontaneous ventilation is controlled by blood carbon dioxide (and pH) levels. In healthy animals, extracorporeal carbon dioxide removal leads to hypoventilation or apnea (Kolobow et al., 1977). During acute respiratory insufficiency, extracorporeal carbon dioxide removal may be used to control spontaneous ventilation, limiting risks of lung damage and relieving dyspnea (Crotti et al., 2012). However, little is known about how spontaneous ventilation changes in response to changes in extracorporeal carbon dioxide removal during acute respiratory insufficiency, especially in humans. Aim of this study is to monitor changes in spontaneous ventilation in awake patients treated with extracorporeal gas exchange support because of acute respiratory insufficiency, in response to changes in extracorporeal carbon dioxide removal.

Official Title
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Changes in Spontaneous Ventilation in Response to Changes in Extracorporeal Carbon Dioxide Removal

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Other: Change in extracorporeal carbon dioxide removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute Respiratory Insufficiency Extracorporeal gas exchange support The patient is spontaneously breathing (including assisted ventilation) Exclusion Criteria: - age below 18 yrs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute Respiratory Distress Syndrome<br>Acute hypoxemia, bilateral pulmonary infiltrates and no evidence of primary left atrial hypertension | Other: Change in extracorporeal carbon dioxide removal<br> <br> |
| Experimental: Chronic Obstructive Pulmonary Disease<br>Acute-on-Chronic Respiratory Insufficiency (patients with Chronic Obstructive Pulmonary Disease) | Other: Change in extracorporeal carbon dioxide removal<br> <br> |
| Experimental: Bridge to Lung Transplant<br>Acute-on-Chronic Respiratory Insufficiency (patients awaiting lung transplant) | Other: Change in extracorporeal carbon dioxide removal<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous ventilation | Extracorporeal carbon dioxide removal will be increased or decreased changing the gas flow to the extracorporeal membrane lung. Actual extracorporeal carbon dioxide removal will be measured. Spontaneous respiratory rate, tidal volume, minute ventilation, esophageal pressure swings and comfort of the patient will be recorded 30-60 minutes after changing extracorporeal carbon dioxide removal. | 30-60 minutes after changing extracorporeal carbon dioxide removal |