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

NCT01953484 | Unknown

• 1 other identifier: VECLA-ECMO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Acute Respiratory Distress Syndrome

EXPERIMENTAL

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

Other: Change in extracorporeal carbon dioxide removal

Chronic Obstructive Pulmonary Disease

EXPERIMENTAL

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

Other: Change in extracorporeal carbon dioxide removal

Bridge to Lung Transplant

EXPERIMENTAL

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

Other: Change in extracorporeal carbon dioxide removal

Interventions

Change in extracorporeal carbon dioxide removal OTHER

Acute Respiratory Distress Syndrome; Bridge to Lung Transplant; Chronic Obstructive Pulmonary Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- age below 18 yrs

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Luciano Gattinoni, Prof.

CONTACT

+39-02-55033285; gattinon@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: October 1, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

IT (1)