- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00141440
The Effect of Cycling Off Criteria During Pressure Support Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients
December 29, 2009 updated by: Policlinico Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Milano, Italy, 20100
- Ospedale Sacco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stable COPD patients during invasive mechanical ventilation
Exclusion Criteria:
- Hemodynamic instability,
- Paralysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
COPD patients
|
evaluated the effect of two different cycling off criteria on breathing pattern, respiratory effort, and gas exchange in patients with chronic obstructive pulmonary disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Respiratory mechanics, gas exchange
Time Frame: 2 minutes
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Comfort of breathing
Time Frame: 2 minutes
|
2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: davide chiumello, md, Policlinico Hospital
- Study Chair: Davide Chiumello, MD, Policlinico
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
August 31, 2005
First Submitted That Met QC Criteria
August 31, 2005
First Posted (Estimate)
September 1, 2005
Study Record Updates
Last Update Posted (Estimate)
December 30, 2009
Last Update Submitted That Met QC Criteria
December 29, 2009
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1073
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.