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

NCT ID: NCT01953484

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

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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

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Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acute Respiratory Distress Syndrome

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

Group Type EXPERIMENTAL

Change in extracorporeal carbon dioxide removal

Intervention Type OTHER

Chronic Obstructive Pulmonary Disease

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

Group Type EXPERIMENTAL

Change in extracorporeal carbon dioxide removal

Intervention Type OTHER

Bridge to Lung Transplant

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

Group Type EXPERIMENTAL

Change in extracorporeal carbon dioxide removal

Intervention Type OTHER

Interventions

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Change in extracorporeal carbon dioxide removal

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- age below 18 yrs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luciano Gattinoni, Prof.

Role: CONTACT

Phone: +39-02-55033285

Email: [email protected]

Other Identifiers

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VECLA-ECMO

Identifier Type: -

Identifier Source: org_study_id