Thoracocentesis of Pleural EffusionNCT04420663
Pleural Manometry in Thoracocentesis
A study testing Pleural Manometry in people with Thoracocentesis of Pleural Effusion, run by Aly Sherif Hassaballa at 1 site in Egypt.
Trial summary
The study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracocentesis of Pleural Effusion
- What is being tested?
- Pleural Manometry
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 31 Dec 2021
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 85 years,
- pleural effusion occupying at least one-third of the ipsilateral hemithorax in P-A chest radiograph (CXR)
- no contraindications for therapeutic thoracentesis
- general health condition allowing prolonged procedure of therapeutic thoracentesis.
Who cannot join
- patients with very small amounts of pleural effusion
- patients on mechanical ventilation
- patients using anticoagulant therapy
- patients refusing to be subjected to thoracocentesis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cardiothoracic Surgery Hospital, Faculty of Medicine, Ain Shams University
Cairo
About this study
Official title: Pleural Manometry During Thoracocentesis in Patients With Malignant Pleural Effusion: How Much Fluid Should we Drain?
The study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions.
Read the detailed description
This prospective controlled trial study will be performed between July 2019 and December 2020. the investigators will enroll patients with large volume pleural effusion referred to our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform therapeutic thoracentesis. All the patients will sign an informed consent for pleural pressure monitoring during and after therapeutic thoracentesis.
The study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions.
- Conditions
- Thoracocentesis of Pleural Effusion
- Being tested
- Pleural Manometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural ManometryDiagnostic test
Recording pleural pressure during therapeutic thoracocentesis using a simple water manometer.
| Study group | Role | What they receive |
|---|---|---|
| Manometer Group | Experimental | Therapeutic thoracentesis will be performed in a sitting position. wide bore catheter as a pleural catheter will be inserted into the pleural cavity. simple water manometer will be connected to the pleural catheter via 3-way adapter.connected to the infusion lines with one draining into the drainage collection bottle and the other pre-flushed with normal saline hanging down till 40 cm below the puncture site and then rising up (forming a "U") with the ascending arm taped to the IV stand. baseline pleural pressure will be registered before the beginning of pleural fluid withdrawal. Pleural pressure curve will subsequently be registered after the withdrawal of each 200 ml of pleural fluid up to a total volume of 1000 ml. Receives: Diagnostic Test: Pleural Manometry |
| Conventional Group | No intervention | Therapeutic thoracentesis will be performed in a sitting position. The skin will be cleaned with betadine antiseptic solution. Pleural aspiration should take place in a clean area using full aseptic techniques. 5-10 cc Lidocaine 2% will be given as local anesthetic in the site of puncture. the IV cannula is advanced till fluid is aspirated. Then, the needle is withdrawn and the catheter is fixed to two 3-way adapters fixed in series placed in between. connected to the infusion lines with one draining into the drainage collection bottle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the pleural pressure
To measure the pleural pressure(mmHg) during thoracocentesis in patients with pleural effusion using a simple water pleural manometer
Measured: Continous monitoring during the whole session of thoracocentesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jul 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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 Thoracocentesis of Pleural EffusionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective controlled trial study will be performed between August 2019 and August 2020. We will enroll patients with large volume pleural effusion referred to our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform therapeutic thoracentesis. All the patients will sign an informed consent for pleural pressure monitoring during and after therapeutic thoracentesis.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aly Sherif Hassaballa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aly Sherif Hassaballa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420663
- Sponsor's protocol ID
- ASHassaballaMD
- Status last verified
- Mar 2022
- First submitted
- 15 Apr 2020
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hassaballa AS, Mostafa A, Hikal T, Elnori A, Elsayed HH. Pleural manometry during thoracocentesis in patients with malignant pleural effusion: A randomized controlled trial. Can J Respir Ther. 2023 Jan 20;59:33-44. doi: 10.29390/cjrt-2022-047. eCollection 2023.
PubMed 36741303
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pleural Manometry During Thoracocentesis in Patients With Malignant Pleural Effusion: How Much Fluid Should we Drain?
- ClinicalTrials.gov ID
- NCT04420663
- Acronym / sponsor ID
- ASHassaballaMD
- Conditions
- Thoracocentesis of Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Aly Sherif HassaballaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Jun 2020 (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.
The study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions.
Detailed description
This prospective controlled trial study will be performed between July 2019 and December 2020. the investigators will enroll patients with large volume pleural effusion referred to our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform therapeutic thoracentesis. All the patients will sign an informed consent for pleural pressure monitoring during and after therapeutic thoracentesis.
The study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This prospective controlled trial study will be performed between August 2019 and August 2020. We will enroll patients with large volume pleural effusion referred to our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform therapeutic thoracentesis. All the patients will sign an informed consent for pleural pressure monitoring during and after therapeutic thoracentesis.
| Arm | Type | Receives |
|---|---|---|
| Manometer Group | Experimental | Diagnostic Test: Pleural ManometryTherapeutic thoracentesis will be performed in a sitting position. wide bore catheter as a pleural catheter will be inserted into the pleural cavity. simple water manometer will be connected to the pleural catheter via 3-way adapter.connected to the infusion lines with one draining into the drainage collection bottle and the other pre-flushed with normal saline hanging down till 40 cm below the puncture site and then rising up (forming a "U") with the ascending arm taped to the IV stand. baseline pleural pressure will be registered before the beginning of pleural fluid withdrawal. Pleural pressure curve will subsequently be registered after the withdrawal of each 200 ml of pleural fluid up to a total volume of 1000 ml. |
| Conventional Group | No intervention | –Therapeutic thoracentesis will be performed in a sitting position. The skin will be cleaned with betadine antiseptic solution. Pleural aspiration should take place in a clean area using full aseptic techniques. 5-10 cc Lidocaine 2% will be given as local anesthetic in the site of puncture. the IV cannula is advanced till fluid is aspirated. Then, the needle is withdrawn and the catheter is fixed to two 3-way adapters fixed in series placed in between. connected to the infusion lines with one draining into the drainage collection bottle. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 and 85 years,
- pleural effusion occupying at least one-third of the ipsilateral hemithorax in P-A chest radiograph (CXR)
- no contraindications for therapeutic thoracentesis
- general health condition allowing prolonged procedure of therapeutic thoracentesis.
Key exclusion criteria (4 listed)
- patients with very small amounts of pleural effusion
- patients on mechanical ventilation
- patients using anticoagulant therapy
- patients refusing to be subjected to thoracocentesis.
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 |
|---|---|---|
| Pleural ManometryRecording pleural pressure during therapeutic thoracocentesis using a simple water manometer. | Diagnostic test | Manometer Group |
Primary outcome
the pleural pressure
Time frame: Continous monitoring during the whole session of thoracocentesis
To measure the pleural pressure(mmHg) during thoracocentesis in patients with pleural effusion using a simple water pleural manometer
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 1 Apr 2022.
- Derived from this study: PubMed 36741303Hassaballa AS, Mostafa A, Hikal T, Elnori A, Elsayed HH. Pleural manometry during thoracocentesis in patients with malignant pleural effusion: A randomized controlled trial. Can J Respir Ther. 2023 Jan 20;59:33-44. doi: 10.29390/cjrt-2022-047. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Thoracocentesis of Pleural Effusion
RecruitingPhase 2
Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]
Pleural Effusion Associated With Pulmonary Infection, Pleural Effusion Disorder
RecruitingObservational study
Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion
Pleural Effusion
Recruiting
DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs
Congestive Heart Failure(CHF), Pleural Effusion Due to Congestive Heart Failure
Not yet recruitingObservational study
Evaluation of Transthoracic Ultrasonography in Differentiating Pleural Effusions
Pleural Effusion, Transudative Pleural Effusion
RecruitingObservational study
Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Supervised Use of an Augmented Reality Simulator
Pleural Effusion, Frist Time Indication to Perform a Thoracentesis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleural Manometry in people with Thoracocentesis of Pleural Effusion, run by Aly Sherif Hassaballa at 1 site in Egypt.
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 4 inclusion and 4 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 1 Apr 2022. 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 Egypt. 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?
the pleural pressure (time frame: Continous monitoring during the whole session of thoracocentesis). 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 NCT04420663, 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 1 Apr 2022.