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NCT01953484 Clinical Trial

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

Respiratory Insufficiency Clinical Trial

Official title:
Changes in Spontaneous Ventilation in Response to Changes in Extracorporeal Carbon Dioxide Removal

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01953484
Other study ID # VECLA-ECMO
Secondary ID
Status Recruiting
Phase N/A
First received September 9, 2013
Last updated October 14, 2013
Start date July 2013

Study information
Verified date October 2013
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Luciano Gattinoni, Prof.
Phone +39-02-55033285
Email gattinon@policlinico.mi.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Change in extracorporeal carbon dioxide removal

Locations
Country Name City State
Italy Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Milan

Sponsors (1)
Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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