COPD (Chronic Obstructive Pulmonary Disease)NCT06751654
Can Total Mechanical Power Be a Determinant of Weaning Failure in Chronic Obstructive Pulmonary Disease (COPD)?
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and ARDS (Acute Respiratory Distress Syndrome), run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
A Comparison of Ventilator Parameters (TV, DP, Total Mechanical Power, etc.) Between Successfully and unsuccessfully Weaned Patients with COPD Undergoing Mechanical Ventilation Due to Respiratory Failure, and Diagnosed with Pneumonia or ARDS in the Intensive Care Unit." Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), ARDS (Acute Respiratory Distress Syndrome), Mechanical Power
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2024to 23 Dec 2024
- 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: Intubated patients with COPD which has been diagnosed Pneumonia or ARDS and have admission to icu and stayed for more than 5 years.
Who may be able to join
- Patients aged 18 years and older
- COPD-diagnosed patients who have been intubated and stayed in the ICU for more than 5 days
Who cannot join
- Patients without electronic medical records
- Patients under 18 years of age
- Patients diagnosed with pulmonary malignancy
- Patients who stayed in the ICU for less than 5 days
- Patients monitored in the ICU without intubation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr Sadi Konuk Research and Training Hospital
Istanbul
About this study
A Comparison of Ventilator Parameters (TV, DP, Total Mechanical Power, etc.) Between Successfully and unsuccessfully Weaned Patients with COPD Undergoing Mechanical Ventilation Due to Respiratory Failure, and Diagnosed with Pneumonia or ARDS in the Intensive Care Unit."
Read the detailed description
The objective of this study is to investigate which mechanical ventilation parameters and clinical findings influence weaning success by comparing successful and unsuccessful weaning patient groups among patients diagnosed with COPD who were intubated and monitored for more than five days in the intensive care unit. The findings of this study may contribute to the development of future treatment protocols and criteria for evaluating the weaning process.
This study is planned to be conducted in two centers: Bakırköy Dr. Sadi Konuk Training and Research Hospital in Istanbul and Shahid Beheshti University of Medical Sciences, Masih Daneshvari Hospital in Tehran. This multicenter study aims to facilitate the comparison of data obtained under different geographical and clinical conditions, thereby enabling a broader analysis of factors influencing the weaning process across a larger patient population.
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), ARDS (Acute Respiratory Distress Syndrome), Mechanical Power, Pneumonia, Weaning Failure
- Keywords
- Mechanical Power, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Acute Lung Injury, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Weaned | patients with successful weaning from mechanic ventilator | |
| Non-weaned | patients who have failed to wean from ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Weaning
The primary outcome of this study will be the successful weaning from mechanical ventilation. This will be defined as the patient being successfully extubated and maintaining adequate oxygenation for more than 48 hours without requiring reintubation or mechanical ventilation support.
Measured: 48 hours
Secondary outcomes (1)
Mechanical Ventilator Parameters
A comparison of total mechanical power between the weaned and non-weaned patient groups.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start6 Dec 2024
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Collaborators
- Masih Daneshvari Hospital
- Responsible party
- Sponsor
- Investigators
- Zafer Cukurova, M.D, Study chair, Bakirkoy Dr. Sadi Konuk Research and Training HospitalSeyed Mohammadreza Hashemian, M.D, Study director, Masih Daneshvari Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751654
- Sponsor's protocol ID
- 2024-12-06
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Total Mechanical Power Be a Determinant of Weaning Failure in Chronic Obstructive Pulmonary Disease (COPD)?
- ClinicalTrials.gov ID
- NCT06751654
- Acronym / sponsor ID
- 2024-12-06
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), ARDS (Acute Respiratory Distress Syndrome), Mechanical Power, Pneumonia, Weaning Failure
- Keywords
- Mechanical Power, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Collaborators
- Masih Daneshvari Hospital
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 30 Dec 2024 (actual)
- 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.
A Comparison of Ventilator Parameters (TV, DP, Total Mechanical Power, etc.) Between Successfully and unsuccessfully Weaned Patients with COPD Undergoing Mechanical Ventilation Due to Respiratory Failure, and Diagnosed with Pneumonia or ARDS in the Intensive Care Unit."
Detailed description
The objective of this study is to investigate which mechanical ventilation parameters and clinical findings influence weaning success by comparing successful and unsuccessful weaning patient groups among patients diagnosed with COPD who were intubated and monitored for more than five days in the intensive care unit. The findings of this study may contribute to the development of future treatment protocols and criteria for evaluating the weaning process.
This study is planned to be conducted in two centers: Bakırköy Dr. Sadi Konuk Training and Research Hospital in Istanbul and Shahid Beheshti University of Medical Sciences, Masih Daneshvari Hospital in Tehran. This multicenter study aims to facilitate the comparison of data obtained under different geographical and clinical conditions, thereby enabling a broader analysis of factors influencing the weaning process across a larger patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weaned | – | –patients with successful weaning from mechanic ventilator |
| Non-weaned | – | –patients who have failed to wean from ventilator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intubated patients with COPD which has been diagnosed Pneumonia or ARDS and have admission to icu and stayed for more than 5 years.
Key inclusion criteria (2 listed)
- Patients aged 18 years and older
- COPD-diagnosed patients who have been intubated and stayed in the ICU for more than 5 days
Key exclusion criteria (5 listed)
- Patients without electronic medical records
- Patients under 18 years of age
- Patients diagnosed with pulmonary malignancy
- Patients who stayed in the ICU for less than 5 days
- Patients monitored in the ICU without intubation
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
Successful Weaning
Time frame: 48 hours
The primary outcome of this study will be the successful weaning from mechanical ventilation. This will be defined as the patient being successfully extubated and maintaining adequate oxygenation for more than 48 hours without requiring reintubation or mechanical ventilation support.
1 secondary outcome
Mechanical Ventilator Parameters
Time frame: 48 hours
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 2024.
- Individual participant dataSharing planned: No
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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.
Zafer Cukurova, M.D study chair
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Seyed Mohammadreza Hashemian, M.D study director
Masih Daneshvari Hospital
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 (Chronic Obstructive Pulmonary Disease) and ARDS (Acute Respiratory Distress Syndrome), run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 5 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 2024. 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 Turkey (Türkiye). 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?
Successful Weaning (time frame: 48 hours). It is what the study was designed to measure, not a finding.
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 30 Dec 2024.