Respiration, ArtificialNCT03394872
Impact of Draining Significant Effusion on Gas Exchange and Lung Mechanics in Patient Under Mechanical Ventilation
An observational study of Respiration, Artificial and Pleural Effusion, run by Dokuz Eylul University.
Trial summary
Patients with acute respiratory failure (ARF) who were receiving mechanical ventilator support, had significant pleural effusion (both transudates and exudates) and drainage plan were evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial, Pleural Effusion, Ultrasonography
- What is being tested?
- Drainage of the pleural effusion
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 30 Aug 2017
- 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: Critical care patients on mechanical ventilation due to acute respiratory failure and have significant pleural effusion who had drainage plan according to İCU protocols decided by primary physician were enrolled for the study
Who may be able to join
- Patients on mechanical ventilation due to acute respiratory failure
- Estimated effusion > 800 ml according to USG
- Have drainage plan according to ICU protocols decided by primary physician
Who cannot join
- Have absolute drainage indication (empyema, hemothorax or chylothorax)
- predicted duration of mechanical ventilation less than 72 hours
- contraindications to drainage,
- underlying disease, which prevents lung expansion (chest deformity, central atelectasis)
- malignant effusions
About this study
Patients with acute respiratory failure (ARF) who were receiving mechanical ventilator support, had significant pleural effusion (both transudates and exudates) and drainage plan were evaluated. Decision to drain, timing and duration of drainage were made by primary physician according to the intensive care unit (ICU) protocols.The estimated amount of effusion (mL) was calculated as the maximum pleura-lung distance (mm) x 20 and significant effusion is accepted as ≥ 800 mL according to thoracic ultrasonography (USG) performed by the intensivist. The amount of effusion drained, mechanical ventilator parameters, arterial blood gas results and hemodynamic data were recorded before, at the 1st hour and at the end of drainage up to 30 days after drainage.
- Conditions
- Respiration, Artificial, Pleural Effusion, Ultrasonography
- Being tested
- Drainage of the pleural effusion
- Keywords
- Pleural effusion, Mechanical Ventilation, Ultrasonography, Drainage
- Medical subject headings
- Respiratory Aspiration, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drainage of the pleural effusionProcedure or surgery
Also called Thoracic Ultrasonography performed by USG certificated intensivist to the all subjects included in the study before drainage
| Study group | Role | What they receive |
|---|---|---|
| Drainage group | Patients under mechanical ventilator support due to acute respiratory failure who had significant pleural effusion and drainage plan according to the intensive Care Unit (ICU) protocols decided by primary physician Receives: Procedure: Drainage of the pleural effusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between estimated and drained effusion volume
Volume of the effusion estimated and drained was recorded (mL)
Measured: 1- Estimated effusion volume just before the drainage (by ultrasonography calculated as described in brief summary) 2- Drained effusion volume just after the drainage is terminated up to 30 days after procedure.
Change in Lung mechanics
Dynamic Compliance (mL/cmH2O)
Measured: 1- Dynamic Compliance just before the drainage 2- Dynamic Compliance just after the drainage is terminated up to 30 days after procedure
Change in Oxygenation
PaO2/FiO2 (fraction of inspired oxygen)
Measured: 1- PaO2/FiO2 just before the drainage 2- PaO2/FiO2 just after the drainage is terminated up to 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 May 2016
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begum Ergan, Dokuz Eylul University
- Investigators
- Barış Yılmaz, MD, Study chair, Fellow of Critical Care in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül UniversityTuğçe Yılmaz, MD, Study chair, Fellow of Critical Care in Department of Neurology and Critical Care Medicine in Dokuz Eylül UniversityBegum Ergan, MD, Principal investigator, Staff in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül UniversityNecati Gokmen, MD, Study director, Staff in Department of Anesthesiology and Critical Care Medicine in Dokuz Eylül UniversityKutlay Aydin, MD, Study chair, Fellow of Critical Care in Department of Anesthsiology and Critical Care Medicine in Dokuz Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394872
- Sponsor's protocol ID
- 2496-GOA
- Status last verified
- Jan 2018
- First submitted
- 19 Dec 2017
- Last updated
- 9 Jan 2018
- 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 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Draining Significant Effusion on Gas Exchange and Lung Mechanics in Patient Under Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03394872
- Acronym / sponsor ID
- 2496-GOA
- Conditions
- Respiration, Artificial, Pleural Effusion, Ultrasonography
- Keywords
- Pleural effusion, Mechanical Ventilation, Ultrasonography, Drainage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 9 Jan 2018 (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.
Patients with acute respiratory failure (ARF) who were receiving mechanical ventilator support, had significant pleural effusion (both transudates and exudates) and drainage plan were evaluated. Decision to drain, timing and duration of drainage were made by primary physician according to the intensive care unit (ICU) protocols.The estimated amount of effusion (mL) was calculated as the maximum pleura-lung distance (mm) x 20 and significant effusion is accepted as ≥ 800 mL according to thoracic ultrasonography (USG) performed by the intensivist. The amount of effusion drained, mechanical ventilator parameters, arterial blood gas results and hemodynamic data were recorded before, at the 1st hour and at the end of drainage up to 30 days after drainage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drainage group | – | Procedure: Drainage of the pleural effusionPatients under mechanical ventilator support due to acute respiratory failure who had significant pleural effusion and drainage plan according to the intensive Care Unit (ICU) protocols decided by primary physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical care patients on mechanical ventilation due to acute respiratory failure and have significant pleural effusion who had drainage plan according to İCU protocols decided by primary physician were enrolled for the study
Key inclusion criteria (3 listed)
- Patients on mechanical ventilation due to acute respiratory failure
- Estimated effusion > 800 ml according to USG
- Have drainage plan according to ICU protocols decided by primary physician
Key exclusion criteria (5 listed)
- Have absolute drainage indication (empyema, hemothorax or chylothorax)
- predicted duration of mechanical ventilation less than 72 hours
- contraindications to drainage,
- underlying disease, which prevents lung expansion (chest deformity, central atelectasis)
- malignant effusions
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 |
|---|---|---|
| Drainage of the pleural effusionAlso: Thoracic Ultrasonography performed by USG certificated intensivist to the all subjects included in the study before drainage | Procedure or surgery | Drainage group |
Primary outcome
Correlation between estimated and drained effusion volume
Time frame: 1- Estimated effusion volume just before the drainage (by ultrasonography calculated as described in brief summary) 2- Drained effusion volume just after the drainage is terminated up to 30 days after procedure.
Volume of the effusion estimated and drained was recorded (mL)
Change in Lung mechanics
Time frame: 1- Dynamic Compliance just before the drainage 2- Dynamic Compliance just after the drainage is terminated up to 30 days after procedure
Dynamic Compliance (mL/cmH2O)
Change in Oxygenation
Time frame: 1- PaO2/FiO2 just before the drainage 2- PaO2/FiO2 just after the drainage is terminated up to 30 days after procedure
PaO2/FiO2 (fraction of inspired oxygen)
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 9 Jan 2018.
- 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.
Barış Yılmaz, MD study chair
Fellow of Critical Care in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül University
Tuğçe Yılmaz, MD study chair
Fellow of Critical Care in Department of Neurology and Critical Care Medicine in Dokuz Eylül University
Begum Ergan, MD principal investigator
Staff in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül University
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration, Artificial and Pleural Effusion, run by Dokuz Eylul University.
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 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Correlation between estimated and drained effusion volume (time frame: 1- Estimated effusion volume just before the drainage (by ultrasonography calculated as described in brief summary) 2- Drained effusion volume just after the drainage is terminated up to 30 days after procedure.). The study lists 3 primary outcomes in all. 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 9 Jan 2018.