COPDNCT00965029
Spirometry in Mechanically Ventilated Chronic Obstructive Pulmonary Disease (COPD) Patients
An observational study of COPD, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Patients with COPD who deteriorate to Respiratory Failure pose a challenge to the intensivist both in ventilating an obstructed patient and in weaning from mechanical ventilation. Currently there are no accepted extubation criteria in COPD patients that could predict successful weaning from mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Sep 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients with respiratory failure due to COPD exacerbation, and on mechanical ventilation
Who may be able to join
- >18
- Mechanically ventilated due to COPD exacerbation
Who cannot join
- decreased level of consciousness
- uncooperative patient
- Bronchial asthma
Trial locations and contacts
1 site in 1 country.
Israel1 site
Arie Soroksky
Beer Yaakov, Zerifin, 70300
Arie Soroksky, MD, 972-8-9779320, soroksky@gmail.com
About this study
Official title: Spirometry in Mechanically Ventilated COPD Patients: Correlation of Lung Function Tests to Successful Weaning From Mechanical Ventilation
Patients with COPD who deteriorate to Respiratory Failure pose a challenge to the intensivist both in ventilating an obstructed patient and in weaning from mechanical ventilation.
Currently there are no accepted extubation criteria in COPD patients that could predict successful weaning from mechanical ventilation. In this study we will attempt to correlate spirometric data to eventual weaning from mechanical ventilation.
Read the detailed description
COPD patients who deteriorate to Respiratory Failure will be recruited. Sedation will be interrupted daily, and each day once the patient is awake and cooperative, spirometry will be performed. FEV1 and FVC will be recorded and later correlated to eventual rate of successful extubation.
- Conditions
- COPD
- Keywords
- COPD, Spirometry, Weaning
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Arie Soroksky, MD, Principal investigator, General ICU, Assaf Harofe MC, Zerifin, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965029
- Sponsor's protocol ID
- 101/09
- Status last verified
- Aug 2009
- First submitted
- 24 Aug 2009
- Last updated
- 5 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spirometry in Mechanically Ventilated COPD Patients: Correlation of Lung Function Tests to Successful Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00965029
- Acronym / sponsor ID
- 101/09
- Conditions
- COPD
- Keywords
- COPD, Spirometry, Weaning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 25 Aug 2009 (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.
Patients with COPD who deteriorate to Respiratory Failure pose a challenge to the intensivist both in ventilating an obstructed patient and in weaning from mechanical ventilation.
Currently there are no accepted extubation criteria in COPD patients that could predict successful weaning from mechanical ventilation. In this study we will attempt to correlate spirometric data to eventual weaning from mechanical ventilation.
Detailed description
COPD patients who deteriorate to Respiratory Failure will be recruited. Sedation will be interrupted daily, and each day once the patient is awake and cooperative, spirometry will be performed. FEV1 and FVC will be recorded and later correlated to eventual rate of successful extubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients with respiratory failure due to COPD exacerbation, and on mechanical ventilation
Key inclusion criteria (2 listed)
- >18
- Mechanically ventilated due to COPD exacerbation
Key exclusion criteria (3 listed)
- decreased level of consciousness
- uncooperative patient
- Bronchial asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2011.
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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.
Arie Soroksky, MD principal investigator
General ICU, Assaf Harofe MC, Zerifin, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Apr 2011. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arie Soroksky, MD (972-8-9779320, soroksky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 5 Apr 2011; AzTrials last refreshed its copy on 4 Nov 2026.