Effect of Patient Rotation on Pleurodesis Success and Patient ComfortNCT07147270
Impact of Patient Position on Chemical Pleurodesis by Chest Ultrasound
A study testing side to side and front to back rotation 30 minutes each in people with Effect of Patient Rotation on Pleurodesis Success and Patient Comfort and Malignant Pleural Effusion, run by Ain Shams University at 1 site in Egypt.
Trial summary
chemical pleurodesis using doxycycline is an acceptable and commonly employed palliation for malignant pleural effusion. Rotation of patient during pleurodesis using the powder from doxycycline capsule is still practiced in some centers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Effect of Patient Rotation on Pleurodesis Success and Patient Comfort, Malignant Pleural Effusion, Pleurodesis
- What is being tested?
- side to side and front to back rotation 30 minutes each
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who will be admitted at Chest department, Ain-Shams University Hospitals with malignant pleural effusions candidate for pleurodesis
Who cannot join
- Multiloculated fluid
- Previous failed pleurodesis
- Liver failure
- Renal failure
- Congestive heart failure
- Prolonged use of steroids or NSAIDs
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed M Abdelsamad contact
About this study
chemical pleurodesis using doxycycline is an acceptable and commonly employed palliation for malignant pleural effusion. Rotation of patient during pleurodesis using the powder from doxycycline capsule is still practiced in some centers. The benefit of rotation practice in pleurodesis can be verified after properly designed study on the outcome of pleurodesis with rotation and non-rotation by chest ultrasound assessment
Read the detailed description
Pleurodesis through thoracoscopy could be done if the pleura appears abnormal on direct inspection thus offers diagnostic and therapeutic procedures in a single sitting. Talc is considered the best known sclerosing agent especially when used by medical thoracoscopy/pleuroscopy (MT/P). Unfortunately, a serious complication can occur with its use. Graded talc,which is the safest form is not available in many developing countries, including Egypt. Also, injectable tetracyclines' synthesis has been ceased worldwide.
Meanwhile, the oral forms of doxycycline are readily available, inexpensive and as effective as its parenteral forms in inducing pleurodesis. Therefore it will be used, aiming to assess the efficacy, safety and outcome of pleurodesis with and without patient rotation using doxycycline in malignant pleural effusion. Rotation of patients during tetracycline pleurodesis has been a common practice even at the moment. However, it had been proven that intrapleural instillation of parental tetracycline, a water soluble substance, to achieve chemical pleurodesis does not require rotation of patients as the tetracycline is distributed completely throughout the pleural space within seconds, and the distribution is not enhanced by patient's rotation.
- Conditions
- Effect of Patient Rotation on Pleurodesis Success and Patient Comfort, Malignant Pleural Effusion, Pleurodesis
- Being tested
- side to side and front to back rotation 30 minutes each
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
side to side and front to back rotation 30 minutes eachOther
side to side and front to back rotation 30 minutes each after pleurodesis
| Study group | Role | What they receive |
|---|---|---|
| no rotation after pleurodesis | No intervention | Not described |
| rotation after pleurodesis | Active comparator | Not described Receives: Other: side to side and front to back rotation 30 minutes each |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of pleural adhesion score in patients with malignant pleural effusion candidates for pleurodesis in group with rotation and the other without rotation
study how patient rotation after pleurodesis affects its success by measuring pleural adherence score by chest ultrasound, a higher adhesion score means successful pleurodesis
Measured: immediatly and after one month from pleurodesis
Secondary outcomes (1)
Measurement of non-verbal Pain score in patients with malignant pleural effusion candidates for pleurodesis in group with rotation and the other without rotation
Estimation of non-verbal pain score in patients with and without rotation after pleurodesis to assess how this rotation affects patients' comfort. A higher pain score means less comfort.
Measured: immediately after pleurodesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 May 2025
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
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 Effect of Patient Rotation on Pleurodesis Success and Patient ComfortStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hieba gamal ezz-elragal awad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147270
- Sponsor's protocol ID
- FMASU R107/2025
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no participant data will be shared
Publications
Ezzelregal HG, Abdelsamad AM. Impact of patient positioning on the efficacy and safety of doxycycline pleurodesis in malignant pleural effusion: a pilot randomized trial. BMC Pulm Med. 2026 Aug 31;26(1):384. doi: 10.1186/s12890-026-04630-3.
PubMed 42669653
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient Position on Chemical Pleurodesis by Chest Ultrasound
- ClinicalTrials.gov ID
- NCT07147270
- Acronym / sponsor ID
- FMASU R107/2025
- Conditions
- Effect of Patient Rotation on Pleurodesis Success and Patient Comfort, Malignant Pleural Effusion, Pleurodesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 29 Aug 2025 (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.
chemical pleurodesis using doxycycline is an acceptable and commonly employed palliation for malignant pleural effusion. Rotation of patient during pleurodesis using the powder from doxycycline capsule is still practiced in some centers. The benefit of rotation practice in pleurodesis can be verified after properly designed study on the outcome of pleurodesis with rotation and non-rotation by chest ultrasound assessment
Detailed description
Pleurodesis through thoracoscopy could be done if the pleura appears abnormal on direct inspection thus offers diagnostic and therapeutic procedures in a single sitting. Talc is considered the best known sclerosing agent especially when used by medical thoracoscopy/pleuroscopy (MT/P). Unfortunately, a serious complication can occur with its use. Graded talc,which is the safest form is not available in many developing countries, including Egypt. Also, injectable tetracyclines' synthesis has been ceased worldwide.
Meanwhile, the oral forms of doxycycline are readily available, inexpensive and as effective as its parenteral forms in inducing pleurodesis. Therefore it will be used, aiming to assess the efficacy, safety and outcome of pleurodesis with and without patient rotation using doxycycline in malignant pleural effusion. Rotation of patients during tetracycline pleurodesis has been a common practice even at the moment. However, it had been proven that intrapleural instillation of parental tetracycline, a water soluble substance, to achieve chemical pleurodesis does not require rotation of patients as the tetracycline is distributed completely throughout the pleural space within seconds, and the distribution is not enhanced by patient's rotation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no rotation after pleurodesis | No intervention | – |
| rotation after pleurodesis | Active comparator | Other: side to side and front to back rotation 30 minutes each |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who will be admitted at Chest department, Ain-Shams University Hospitals with malignant pleural effusions candidate for pleurodesis
Key exclusion criteria (7 listed)
- Multiloculated fluid
- Previous failed pleurodesis
- Liver failure
- Renal failure
- Congestive heart failure
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 |
|---|---|---|
| side to side and front to back rotation 30 minutes eachside to side and front to back rotation 30 minutes each after pleurodesis | Other | rotation after pleurodesis |
Primary outcome
Measurement of pleural adhesion score in patients with malignant pleural effusion candidates for pleurodesis in group with rotation and the other without rotation
Time frame: immediatly and after one month from pleurodesis
study how patient rotation after pleurodesis affects its success by measuring pleural adherence score by chest ultrasound, a higher adhesion score means successful pleurodesis
1 secondary outcome
Measurement of non-verbal Pain score in patients with malignant pleural effusion candidates for pleurodesis in group with rotation and the other without rotation
Time frame: immediately after pleurodesis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Derived from this study: PubMed 42669653Ezzelregal HG, Abdelsamad AM. Impact of patient positioning on the efficacy and safety of doxycycline pleurodesis in malignant pleural effusion: a pilot randomized trial. BMC Pulm Med. 2026 Aug 31;26(1):384. doi: 10.1186/s12890-026-04630-3.
- Individual participant dataSharing planned: No. no participant data will be shared
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.
Ahmed M Abdelsamad contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing side to side and front to back rotation 30 minutes each in people with Effect of Patient Rotation on Pleurodesis Success and Patient Comfort and Malignant Pleural Effusion, run by Ain Shams University 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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hieba G Ezzelregal, MD (01002041611, hiebagamal24@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pleural adhesion score in patients with malignant pleural effusion candidates for pleurodesis in group with rotation and the other without rotation (time frame: immediatly and after one month from pleurodesis). 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 NCT07147270, 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 29 Aug 2025.