Chronic Obstructive Pulmonary DiseaseNCT00141440
The Effect of Cycling Off Criteria During Pressure Support Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing mechanical ventilation in people with Chronic Obstructive Pulmonary Disease, run by Policlinico Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2005to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stable COPD patients during invasive mechanical ventilation
Who cannot join
- Hemodynamic instability,
- Paralysis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- mechanical ventilation
- Keywords
- gas exchange, pressure support ventilation, respiratory mechanics, COPD patients
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationProcedure or surgery
evaluated the effect of two different cycling off criteria on breathing pattern, respiratory effort, and gas exchange in patients with chronic obstructive pulmonary disease
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | COPD patients Receives: Procedure: mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory mechanics, gas exchange
Measured: 2 minutes
Secondary outcomes (1)
Comfort of breathing
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Investigators
- davide chiumello, md, Principal investigator, Policlinico HospitalDavide Chiumello, MD, Study chair, Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141440
- Sponsor's protocol ID
- 1073
- Status last verified
- Sep 2008
- First submitted
- 31 Aug 2005
- Last updated
- 30 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17893630
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cycling Off Criteria During Pressure Support Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT00141440
- Acronym / sponsor ID
- 1073
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- gas exchange, pressure support ventilation, respiratory mechanics, COPD patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: mechanical ventilationCOPD patients |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Stable COPD patients during invasive mechanical ventilation
Key exclusion criteria (2 listed)
- Hemodynamic instability,
- Paralysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical ventilationevaluated the effect of two different cycling off criteria on breathing pattern, respiratory effort, and gas exchange in patients with chronic obstructive pulmonary disease | Procedure or surgery | 1 |
Primary outcome
Respiratory mechanics, gas exchange
Time frame: 2 minutes
1 secondary outcome
Comfort of breathing
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2009.
- Results publication: PubMed 17893630Chiumello 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
davide chiumello, md principal investigator
Policlinico Hospital
Davide Chiumello, MD study chair
Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical ventilation in people with Chronic Obstructive Pulmonary Disease, run by Policlinico Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory mechanics, gas exchange (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00141440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2009.