Respiratory FailurePhase 4NCT00355732
Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients
A Phase 4 study testing Weaning from mechanical ventilation in people with Respiratory Failure, run by Dr. Josip Benčević General Hospital at 2 sites in Croatia.
Trial summary
To evaluate and compare two methods of weaning from mechanical ventilation in patients with chronic obstructive pulmonary disease (COPD) where the extubation failed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Weaning from mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesCroatia
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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
Who may be able to join
- COPD
- exacerbation of dyspnea <2 weeks
- signs of respiratory muscle dysfunction
Who cannot join
- non COPD patients
- age <18 years
- tracheotomy
- MV duration shorter than 24h
- use of MV on admission to the ICU or transfer to some other ICU for treatment continuation
- patients who died or weaning from MV was discontinued because of another associated disorder
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- central nerve system disorders unrelated to hypercapnic encephalopathy or hypoxemia
- cardiac arrest within 5 days
- patients scheduled for organ donation
Trial locations and contacts
2 sites in 1 country.
Croatia2 sites
Dr. Josip Benčević General Hospital
Slavonski Brod, 35000
Clinic Hospital Center Zagreb
Zagreb, 10000
About this study
Official title: Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients; Randomized Prospective Study
To evaluate and compare two methods of weaning from mechanical ventilation in patients with chronic obstructive pulmonary disease (COPD) where the extubation failed.
Read the detailed description
A prospective, randomized trial was performed in a multidisciplinary Intensive Care Unit (ICU) for the duration of 2 years. A total of 136 COPD patients who required mechanical ventilation longer than 24 h fulfilled the inclusion criteria and they present the research sample. After fulfilling the criteria for weaning, patients were randomized to a 2-h spontaneous breathing trial with either T-tube or pressure support ventilation (PSV). The patients with successful 2-h trial were extubated and were excluded from further research. Patients with 2-h trial failure were defined as difficult to wean, they had mechanical ventilation reinstated and the same weaning procedure was repeated after 24 h, if the patient again fulfilled the weaning criteria. In these patients, two methods of weaning were compared according to the patients clinical characteristics, objective parameters and procedure outcome.
31 (47%) patient with T-tube and 32 (46%) patients with PSV had 2-h trial failure. Of those patients, successful extubation was in 17 (56%) patients with T-tube and in 23 (72%) with PSV (P <0.001), whereas extubation failure was in 14 (44%) patients with T-tube and in 9 (28%) patients with PSV (P <0.001). Mechanical ventilation duration was 186.7 h with T-tube and 163.2 h with PSV (P <0.001), time spent in ICU was 240.7 h with T-tube and 210.2 h with PSV (P <0.001).
In patients with COPD who failed the 2-h spontaneous breathing trial, based on parameters of procedure outcome, high advantage of PSV method was confirmed.
- Conditions
- Respiratory Failure
- Being tested
- Weaning from mechanical ventilation
- Keywords
- Respiration, COPD, Mechanical Ventilation, Ventilator Weaning, Respiratory Failure, ICU, Pressure Support Ventilation
- Medical subject headings
- Respiratory Insufficiency, Respiratory Aspiration, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weaning from mechanical ventilationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Dr. Josip Benčević General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zagreb
- Investigators
- Ivo Matić, MD PhD, Study chair, Department of Anesthesiology and Intensive Care, Dr. Josip Benčević General Hospital, Slavonski Brod, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355732
- Sponsor's protocol ID
- 123456
- Status last verified
- Jul 2006
- First submitted
- 23 Jul 2006
- Last updated
- 26 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients; Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT00355732
- Acronym / sponsor ID
- 123456
- Conditions
- Respiratory Failure
- Keywords
- Respiration, COPD, Mechanical Ventilation, Ventilator Weaning, Respiratory Failure, ICU, Pressure Support Ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Dr. Josip Benčević General HospitalUniversity, hospital or other
- Collaborators
- University of Zagreb
- First posted
- 25 Jul 2006 (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.
To evaluate and compare two methods of weaning from mechanical ventilation in patients with chronic obstructive pulmonary disease (COPD) where the extubation failed.
Detailed description
A prospective, randomized trial was performed in a multidisciplinary Intensive Care Unit (ICU) for the duration of 2 years. A total of 136 COPD patients who required mechanical ventilation longer than 24 h fulfilled the inclusion criteria and they present the research sample. After fulfilling the criteria for weaning, patients were randomized to a 2-h spontaneous breathing trial with either T-tube or pressure support ventilation (PSV). The patients with successful 2-h trial were extubated and were excluded from further research. Patients with 2-h trial failure were defined as difficult to wean, they had mechanical ventilation reinstated and the same weaning procedure was repeated after 24 h, if the patient again fulfilled the weaning criteria. In these patients, two methods of weaning were compared according to the patients clinical characteristics, objective parameters and procedure outcome.
31 (47%) patient with T-tube and 32 (46%) patients with PSV had 2-h trial failure. Of those patients, successful extubation was in 17 (56%) patients with T-tube and in 23 (72%) with PSV (P <0.001), whereas extubation failure was in 14 (44%) patients with T-tube and in 9 (28%) patients with PSV (P <0.001). Mechanical ventilation duration was 186.7 h with T-tube and 163.2 h with PSV (P <0.001), time spent in ICU was 240.7 h with T-tube and 210.2 h with PSV (P <0.001).
In patients with COPD who failed the 2-h spontaneous breathing trial, based on parameters of procedure outcome, high advantage of PSV method was confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD
- exacerbation of dyspnea <2 weeks
- signs of respiratory muscle dysfunction
Key exclusion criteria (9 listed)
- non COPD patients
- age <18 years
- tracheotomy
- MV duration shorter than 24h
- use of MV on admission to the ICU or transfer to some other ICU for treatment continuation
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 |
|---|---|---|
| Weaning from mechanical ventilation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 26 Oct 2006.
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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.
Ivo Matić, MD PhD study chair
Department of Anesthesiology and Intensive Care, Dr. Josip Benčević General Hospital, Slavonski Brod, Croatia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Weaning from mechanical ventilation in people with Respiratory Failure, run by Dr. Josip Benčević General Hospital at 2 sites in Croatia.
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 3 inclusion and 9 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 26 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 26 Oct 2006.