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

Not Applicable

• Conditions: Respiratory Insufficiency
• Interventions: Other: Change in extracorporeal carbon dioxide removal

• Registration Number: NCT01953484
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-26
• Status Verified: 2013-10
• Study First Posted: 2013-10-01
• Last Update Submitted: 2013-10-14
• Last Update Posted: 2013-10-16
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• age below 18 yrs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute Respiratory Distress Syndrome	Change in extracorporeal carbon dioxide removal	Acute hypoxemia, bilateral pulmonary infiltrates and no evidence of primary left atrial hypertension
Chronic Obstructive Pulmonary Disease	Change in extracorporeal carbon dioxide removal	Acute-on-Chronic Respiratory Insufficiency (patients with Chronic Obstructive Pulmonary Disease)
Bridge to Lung Transplant	Change in extracorporeal carbon dioxide removal	Acute-on-Chronic Respiratory Insufficiency (patients awaiting lung transplant)

Primary Outcome Measures

Name	Time	Method
Spontaneous ventilation	30-60 minutes after changing extracorporeal carbon dioxide removal	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.

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy