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

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ClinicalTrials.gov Identifier: NCT01953484
Recruitment Status : Unknown
Verified October 2013 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was:  Recruiting
First Posted : October 1, 2013
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Other: Change in extracorporeal carbon dioxide removal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes in Spontaneous Ventilation in Response to Changes in Extracorporeal Carbon Dioxide Removal
Study Start Date : July 2013
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Spontaneous ventilation [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- age below 18 yrs


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953484


Contacts
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Contact: Luciano Gattinoni, Prof. +39-02-55033285 gattinon@policlinico.mi.it

Locations
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Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Recruiting
Milan, Italy, 20122
Principal Investigator: Stefania Crotti, MD         
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT01953484     History of Changes
Other Study ID Numbers: VECLA-ECMO
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases