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

Primary Purpose

Respiratory Insufficiency

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Change in extracorporeal carbon dioxide removal

About this trial

This is an interventional treatment trial for Respiratory Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

- age below 18 yrs

Sites / Locations

Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Acute Respiratory Distress Syndrome

Chronic Obstructive Pulmonary Disease

Bridge to Lung Transplant

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01953484

First Posted

September 9, 2013

Last Updated

October 14, 2013

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

1. Study Identification

Unique Protocol Identification Number

NCT01953484

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acute Respiratory Distress Syndrome

Arm Type

Experimental

Arm Description

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

Arm Title

Chronic Obstructive Pulmonary Disease

Arm Type

Experimental

Arm Description

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

Arm Title

Bridge to Lung Transplant

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Change in extracorporeal carbon dioxide removal

Primary Outcome Measure Information:

Title

Spontaneous ventilation

Description

Time Frame

30-60 minutes after changing extracorporeal carbon dioxide removal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Acute Respiratory Insufficiency Extracorporeal gas exchange support The patient is spontaneously breathing (including assisted ventilation) Exclusion Criteria: - age below 18 yrs

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luciano Gattinoni, Prof.

Phone

+39-02-55033285

gattinon@policlinico.mi.it

Facility Information:

Facility Name

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

City

Milan

ZIP/Postal Code

20122

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefania Crotti, MD

12. IPD Sharing Statement

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

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