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The Effect of Cycling Off Criteria During Pressure Support Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

mechanical ventilation

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring gas exchange, pressure support ventilation, respiratory mechanics, COPD patients

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Stable COPD patients during invasive mechanical ventilation Exclusion Criteria: Hemodynamic instability, Paralysis

Sites / Locations

Ospedale Sacco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

COPD patients

Outcomes

Primary Outcome Measures

Respiratory mechanics, gas exchange

Secondary Outcome Measures

Comfort of breathing

Full Information

NCT ID

NCT00141440

First Posted

August 31, 2005

Last Updated

December 29, 2009

Sponsor

Policlinico Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00141440

Brief Title

The Effect of Cycling Off Criteria During Pressure Support Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients

Official Title

The Effect of Cycling Off Criteria During Pressure Support Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Policlinico Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators' aim is to study the effect of cycling off criteria during pressure support ventilation in COPD patients at two levels of PEEP and PSV.

Detailed Description

In this study two levels of cycling off criteria at two levels of PEEP and PSV were tested in term of gas exchange, respiratory mechanics, work of breathing and patient comfort.

6. Conditions and Keywords

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

Chronic Obstructive Pulmonary Disease

Keywords

gas exchange, pressure support ventilation, respiratory mechanics, COPD patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

COPD patients

Intervention Type

Procedure

Intervention Name(s)

mechanical ventilation

Intervention Description

evaluated the effect of two different cycling off criteria on breathing pattern, respiratory effort, and gas exchange in patients with chronic obstructive pulmonary disease

Primary Outcome Measure Information:

Title

Respiratory mechanics, gas exchange

Time Frame

2 minutes

Secondary Outcome Measure Information:

Title

Comfort of breathing

Time Frame

2 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Stable COPD patients during invasive mechanical ventilation Exclusion Criteria: Hemodynamic instability, Paralysis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

davide chiumello, md

Organizational Affiliation

Policlinico Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Davide Chiumello, MD

Organizational Affiliation

Policlinico

Official's Role

Study Chair

Facility Information:

Facility Name

Ospedale Sacco

City

Milano

ZIP/Postal Code

20100

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

17893630

Citation

Chiumello D, Polli F, Tallarini F, Chierichetti M, Motta G, Azzari S, Colombo R, Rech R, Pelosi P, Raimondi F, Gattinoni L. Effect of different cycling-off criteria and positive end-expiratory pressure during pressure support ventilation in patients with chronic obstructive pulmonary disease. Crit Care Med. 2007 Nov;35(11):2547-52. doi: 10.1097/01.CCM.0000287594.80110.34.

Results Reference

result

Learn more about this trial

The Effect of Cycling Off Criteria During Pressure Support Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients

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