Air introduction during pleural effusion drainage for trapped lung
Air Entrainment vs. Standard Treatment in Non-Expandable Lung With Persistent Pleural Effusion: A Randomised Controlled Double-Blind Trial
NA · Cambridge University Hospitals NHS Foundation Trust · NCT06959719
This study is testing if adding air during the drainage of fluid from the chest can help adults with a trapped lung feel less pain and have a better experience compared to the usual method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (other) |
| Locations | 1 site (Cambridge, Cambridgeshire) |
| Trial ID | NCT06959719 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the effectiveness of controlled air introduction into the pleural space during drainage of pleural effusions in patients with non-expandable lung (NEL). The study aims to determine if this air entrainment technique can reduce pain, improve patient satisfaction, and enhance fluid drainage compared to standard treatment. Participants will be randomly assigned to either the air entrainment group or the control group, with assessments made on pain relief, fluid volume drained, and overall patient experience. The trial is conducted at Cambridge University Hospital and includes adults scheduled for pleural effusion drainage.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of non-expandable lung and persistent pleural effusion scheduled for drainage.
Not a fit: Patients with a history of pleurodesis, active infections, or those requiring indwelling pleural catheters may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve the overall experience for patients undergoing pleural effusion drainage.
How similar studies have performed: While this specific approach is novel, preliminary evaluations suggest that air entrainment may provide better pain relief than traditional methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older with a suspected or confirmed diagnosis of NEL and persistent pleural effusion. * Patients who are scheduled for pleural effusion drainage as part of their standard care. * Ability to adequately understand verbal or written information in English and provide informed consent in English. Exclusion Criteria: * Patients with a history of pleurodesis or other procedures that may affect pleural dynamics. * Patients with active infections or other acute medical conditions that could interfere with the study. * Patient with multifactorial pain and high baseline score pain defined as VAS \>= 5 * Patients requiring IPC * Individuals with known contraindications to pleural drainage or air entrainment. * Patients who cannot provide informed consent in English, do not adequately understand verbal or written information in English or have special communication needs.
Where this trial is running
Cambridge, Cambridgeshire
- Addenbrooke's Hospital — Cambridge, Cambridgeshire, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Emilia M SWIETLIK, MD PhD
- Email: e.swietlik@nhs.net
- Phone: +447736750560
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-expandable Lung, Trapped Lung, Pleural Effusion, Malignant Pleural Effusions, air entrainment, trapped lung, non-expandable lung, pleural effusion