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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Unknown

Conditions: Respiratory Insufficiency

Treatments: Other: Change in extracorporeal carbon dioxide removal

Study type: Interventional

Funder types: Other

Identifiers

NCT01953484

VECLA-ECMO

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute Respiratory Insufficiency
• Extracorporeal gas exchange support
• The patient is spontaneously breathing (including assisted ventilation)

Exclusion criteria

• age below 18 yrs

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Acute Respiratory Distress Syndrome

Experimental group

Description:

Acute hypoxemia, bilateral pulmonary infiltrates and no evidence of primary left atrial hypertension

Treatment:

Other: Change in extracorporeal carbon dioxide removal

Chronic Obstructive Pulmonary Disease

Experimental group

Description:

Acute-on-Chronic Respiratory Insufficiency (patients with Chronic Obstructive Pulmonary Disease)

Treatment:

Other: Change in extracorporeal carbon dioxide removal

Bridge to Lung Transplant

Experimental group

Description:

Acute-on-Chronic Respiratory Insufficiency (patients awaiting lung transplant)

Treatment:

Other: Change in extracorporeal carbon dioxide removal