Impact of Patient Position on Chemical Pleurodesis by Chest Ultrasound

NCT ID: NCT07147270

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-02-28

Brief Summary

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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

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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

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Effect of Patient Rotation on Pleurodesis Success and Patient Comfort Malignant Pleural Effusion Pleurodesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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no rotation after pleurodesis

Group Type NO_INTERVENTION

No interventions assigned to this group

rotation after pleurodesis

Group Type ACTIVE_COMPARATOR

side to side and front to back rotation 30 minutes each

Intervention Type OTHER

side to side and front to back rotation 30 minutes each after pleurodesis

Interventions

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side to side and front to back rotation 30 minutes each

side to side and front to back rotation 30 minutes each after pleurodesis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who will be admitted at Chest department, Ain-Shams University Hospitals with malignant pleural effusions candidate for pleurodesis

Exclusion Criteria

* Multiloculated fluid
* Previous failed pleurodesis
* Liver failure
* Renal failure
* Congestive heart failure
* Prolonged use of steroids or NSAIDs
* Refusal to participate
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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hieba gamal ezz-elragal awad

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams university

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hieba G Ezzelregal, MD

Role: CONTACT

01002041611

Ahmed M Abdelsamad

Role: CONTACT

01008662384

Facility Contacts

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Fatema S Ebeid

Role: primary

Other Identifiers

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FMASU R107/2025

Identifier Type: -

Identifier Source: org_study_id

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