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Recruiting NCT07147270

Impact of Patient Position on Chemical Pleurodesis by Chest Ultrasound

No phase Interventional Effect of Patient Rotation on Pleurodesis Success and Patient Comfort Malignant Pleural Effusion Pleurodesis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: side to side and front to back rotation 30 minutes each.
Who it may be relevant to
Registry conditions: Effect of Patient Rotation on Pleurodesis Success and Patient Comfort, Malignant Pleural Effusion, Pleurodesis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (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 [Time frame: immediately after pleurodesis]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Ain Shams university — Cairo

Identifiers

NCT: NCT07147270 · FMASU R107/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗