Non-expandable LungARMSTRONGNCT06959719
ARMSTRONG - Air entRainMent vS sTandard tReatment in nOn-expandable luNG
A study testing Air Entrainment - intentional introduction of the atmospheric air into the pleural space. in people with Non-expandable Lung and Trapped Lung, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a randomised controlled trial evaluating whether controlled air introduction into pleural space (air entrainment) during pleural effusion drainage reduces pain, improves patient satisfaction, and facilitates more effective drainage in patients with non-expandable lung (NEL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-expandable Lung, Trapped Lung, Pleural Effusion
- What is being tested?
- Air Entrainment - intentional introduction of the atmospheric air into the pleural space.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Apr 2025to 30 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jurgen Herre, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0BB
07736750560
About this study
Official title: Air Entrainment vs. Standard Treatment in Non-Expandable Lung With Persistent Pleural Effusion: A Randomised Controlled Double-Blind Trial
This is a randomised controlled trial evaluating whether controlled air introduction into pleural space (air entrainment) during pleural effusion drainage reduces pain, improves patient satisfaction, and facilitates more effective drainage in patients with non-expandable lung (NEL).
NEL lung is a common complication in patients with malignant or chronic pleural effusions, where the lung fails to fully re-expand after fluid removal due to pleural disease or fibrosis. In these patients, drainage often creates excessive negative pressure within the pleural cavity, leading to pain, vasovagal episodes, early termination of drainage, and the need for repeated procedures.
Read more
This study investigates a simple, safe, and low-cost intervention using a standard 3-way tap attached to the drainage system. By intermittently opening the tap to atmospheric air during drainage, air enters the pleural cavity in a controlled fashion, reducing negative pressure and potentially reducing pain, improving drainage tolerance, and minimising the need for repeated procedures.
Pleural effusion drainage is a common procedure in patients with advanced malignancy or chronic pleural disease. In patients with NEL, fluid removal creates a vacuum effect within the pleural space due to the inability of the lung to fully re-expand. This negative pressure is a key driver of severe procedural pain, vasovagal symptoms, and premature cessation of drainage. It may also necessitate multiple drainage procedures over a short period.
Currently, there are limited strategies to mitigate this problem, often relying on stopping the procedure prematurely or on analgesia, which does not address the underlying cause.
This trial evaluates the introduction of atmospheric air into the pleural space during drainage as a pragmatic, low-cost solution. The technique uses standard equipment - a 3-way tap - allowing air to be introduced safely and intermittently during drainage to reduce the vacuum effect.
Patients undergoing therapeutic pleural drainage with an indwelling catheter or chest drain will be randomised in a 2:1 ratio to:
Standard drainage care (control group)
Drainage with intermittent controlled air introduction (intervention group)
Air entrainment will be performed by briefly opening the 3-way tap to atmospheric air during drainage up to five times, based on patient discomfort and operator discretion. This aims to equalise pleural pressures, reduce pain, and improve drainage outcomes.
Randomisation is weighted 2:1 towards the intervention group to maximise the number of patients who may benefit, following favourable preliminary data. Both patients and outcome assessors will be blinded to group allocation.
Outcomes collected
Primary Outcomes:
Patient-reported pain scores during drainage - Pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores represent a worse outcome.
Secondary Outcomes:
Volume of pleural fluid drained Number of pleural drainage procedures required Time interval between drainage procedures Incidence of complications (e.g., pneumothorax, re-expansion pulmonary oedema, infection) Reasons for incomplete drainage, including the presence and characteristics of non-expandable lung Patient-reported satisfaction with the drainage procedure
Read the detailed description
Background and Rationale Air entrainment during pleural effusion drainage may improve pain control, increase fluid removal, and reduce repeat procedures in patients with non-expandable lung (NEL). A local evaluation showed greater pain relief than opioids without adverse events. This study compares air entrainment with standard drainage in NEL.
Objectives
Primary: Determine if air entrainment offers superior pain relief vs standard drainage.
Secondary: Compare fluid volume drained, time to repeat drainage, complication rates (infection, hypotension, air leaks, persistent pain), and patient satisfaction. The questionnaire assessed patient experience across four areas: pre-procedure, during the procedure, post-procedure, and overall care. Each item used 5-point Likert scales. Pre-procedure: Satisfaction with information, understanding, scheduling, and communication. During: Comfort, pain management, staff professionalism, and privacy. Post-procedure: Clarity of aftercare, symptom control, and follow-up. Overall: General satisfaction and likelihood to recommend.
Study Design Prospective, double-blind, randomised intervention study (2:1 ratio) at Cambridge University Hospital. All patients undergoing thoracentesis will be screened; only those with confirmed NEL will be analysed.
Randomisation Patients will be randomised 2:1 (intervention:control) to maximise exposure to the intervention. Allocation is blinded to both patients and VAS assessors.
Population
Inclusion: Adults (≥18) with suspected/confirmed NEL and persistent pleural effusion undergoing thoracentesis; English-speaking and able to consent.
Exclusion: Prior pleurodesis, active infection, baseline VAS ≥5, IPC requirement, contraindications, or inability to consent.
Sample Size 41 NEL patients (27 intervention, 14 control), allowing for 30% dropout. Powered for a 3.4 cm VAS difference (SD 3.1), power = 0.8, alpha = 0.05. Interim analysis after enrolment of 7 control and 14 intervention patients.
Interventions
Intervention: Air introduced into pleural space via 3-way tap to relieve negative pressure (up to five times/session).
Control: Standard thoracentesis, stopped at first discomfort.
Outcomes
Primary Outcome: Pain will be measured using the Visual Analogue Scale (VAS) at four time points: pre-procedure, during the procedure, immediately post-procedure, and 10-15 minutes after the procedure. The VAS is a 10 cm horizontal line with two anchors: 0 represents "no pain" and 10 represents "worst imaginable pain." Patients will be asked to mark the point on the line that corresponds to their pain level, and the distance from the 0 point will be recorded in centimeters to quantify pain intensity.
Secondary Outcomes:
Volume Drained: The total volume of fluid drained will be measured in milliliters (mL).
Time to Repeat Procedure: The time to repeat the procedure, if required, will be recorded in days.
Complications: The occurrence of complications, such as infection, hypotension, air leaks, or persistent pain, will be documented.
Satisfaction: Patient satisfaction will be assessed through a questionnaire, which evaluates various aspects of their experience, including pre-procedure communication, comfort during the procedure, pain management, post-procedure care, and overall experience. Satisfaction will be measured on a Likert scale ranging from "very satisfied" to "very dissatisfied."
Methodology Baseline VAS and clinical data collected. Procedure performed as per allocation. Post-procedure data includes VAS, fluid volume, complications, satisfaction, and follow-up for up to 6 months or until IPC/VATS/death.
Analysis Pain: t-test or Mann-Whitney U, depending on data distribution. Secondary outcomes: t-test, Mann-Whitney U, Chi-square or Fisher's exact depending on data type and distribution.
Analysis will follow the intention-to-treat (ITT) principle, with all patients analysed in their originally assigned groups. Missing data will be addressed using appropriate imputation methods (e.g., multiple imputation), and sensitivity analyses will be conducted to assess the robustness of findings under different missing data assumptions.
Ethics REC Ref: 25/LO/0128 | IRAS ID: 348247 Written informed consent required. Risks: Discomfort, minor complications. Benefits: Possible better pain control and fewer procedures.
Data Management Data stored securely in EPIC with restricted access. Consent forms digitised. Analysis based on anonymised data.
Patient and Public Involvement (PPI) Patient feedback informed the design of patient-facing study materials.
Dissemination Results will be published, presented, shared with stakeholders, and posted on the CUH website. Trial to be registered on ClinicalTrials.gov.
- Being tested
- Air Entrainment - intentional introduction of the atmospheric air into the pleural space.
- Keywords
- air entrainment, trapped lung, non-expandable lung (NEL), pleural effusion, malignant pleural effusion
- Medical subject headings
- Pleural Effusion, Pleural Effusion, Malignant, Myeloproliferative Disorder, Chronic, with Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Entrainment - intentional introduction of the atmospheric air into the pleural space.Procedure or surgery
This intervention is distinct in that it uses a standard 3-way tap, already present in routine pleural drainage procedures, to intentionally introduce atmospheric air into the pleural space in a controlled and repeatable manner. Unlike other studies where air entrainment may occur incidentally or as part of more invasive procedures, this method specifically utilises precise manipulation of the tap handle to allow intermittent air entry, aiming to reduce negative intrapleural pressure and associated pain during fluid drainage. Air entry is carefully controlled, can be repeated up to five times per procedure, and does not interfere with fluid drainage or introduce additional equipment or complexity.
| Study group | Role | What they receive |
|---|---|---|
| Standard practice | No intervention | Fluid drainage will be performed according to standard practice, with cessation of fluid removal at the first sign of patient discomfort to prevent pain. |
| Air Entrainment | Experimental | During pleural effusion drainage, atmospheric air will be intentionally introduced into the pleural space by opening the 3-way tap to air. This aims to reduce excessive negative pressure, which can create a vacuum effect within the pleural space and is thought to contribute to patient pain during drainage. The tap allows controlled air entry without fluid leakage, helping to minimise pain while maintaining safe drainage. Receives: Procedure: Air Entrainment - intentional introduction of the atmospheric air into the pleural space. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief
Pain will be measured using the Visual Analog Scale (VAS) before, during, and immediately after the drainage procedure and again 10-15 minutes later to capture the progression of relief.
Measured: From the procedure start until 15 minutes after the procedure
Secondary outcomes (5)
Drainage Volumes
The total volume of fluid removed during each drainage procedure.
Measured: Up to 6 months post-randomization
Number of pleural drainage procedures required.
Total number of pleural drainage procedures performed during the study period.
Measured: Up to 6 months post-randomization
Time interval between drainage procedures.
Time interval between consecutive pleural drainage procedures, measured in days, throughout the study period.
Measured: Up to 6 months post-randomization
Complications
Incidence of procedure-related complications, including infections, hypotension, air leaks, and persistent pain.
Measured: Up to 6 months post-randomization
Patient Satisfaction
Assessed through a post-procedure survey using a standardised satisfaction questionnaire.
Measured: At each in-person visit, through study completion (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start14 Apr 2025
- Primary completionApr 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-expandable LungStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group, randomized controlled trial with a 2:1 allocation ratio (intervention:control). The unequal allocation was chosen to maximise the number of participants receiving the potentially beneficial intervention, following favourable initial data from service evaluation. Randomization will be performed centrally, and both participants and outcome assessors will be blinded to group allocation to minimize bias.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959719
- Sponsor's protocol ID
- A097090
- Acronym
- ARMSTRONG
- Status last verified
- May 2025
- First submitted
- 8 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that may be shared includes pain scores recorded during the procedure, the volume of pleural effusion drained, any complications occurring during or after the procedure, and details of incomplete drainage, including evidence of and reasons for trapped lung. This data may be shared to support further research conducted by both commercial and non-commercial organisations, within the UK and internationally.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Entrainment vs. Standard Treatment in Non-Expandable Lung With Persistent Pleural Effusion: A Randomised Controlled Double-Blind Trial
- ClinicalTrials.gov ID
- NCT06959719
- Acronym / sponsor ID
- ARMSTRONG / A097090
- Keywords
- air entrainment, trapped lung, non-expandable lung (NEL), pleural effusion, malignant pleural effusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 7 May 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.
This is a randomised controlled trial evaluating whether controlled air introduction into pleural space (air entrainment) during pleural effusion drainage reduces pain, improves patient satisfaction, and facilitates more effective drainage in patients with non-expandable lung (NEL).
NEL lung is a common complication in patients with malignant or chronic pleural effusions, where the lung fails to fully re-expand after fluid removal due to pleural disease or fibrosis. In these patients, drainage often creates excessive negative pressure within the pleural cavity, leading to pain, vasovagal episodes, early termination of drainage, and the need for repeated procedures.
This study investigates a simple, safe, and low-cost intervention using a standard 3-way tap attached to the drainage system. By intermittently opening the tap to atmospheric air during drainage, air enters the pleural cavity in a controlled fashion, reducing negative pressure and potentially reducing pain, improving drainage tolerance, and minimising the need for repeated procedures.
Pleural effusion drainage is a common procedure in patients with advanced malignancy or chronic pleural disease. In patients with NEL, fluid removal creates a vacuum effect within the pleural space due to the inability of the lung to fully re-expand. This negative pressure is a key driver of severe procedural pain, vasovagal symptoms, and premature cessation of drainage. It may also necessitate multiple drainage procedures over a short period.
Currently, there are limited strategies to mitigate this problem, often relying on stopping the procedure prematurely or on analgesia, which does not address the underlying cause.
This trial evaluates the introduction of atmospheric air into the pleural space during drainage as a pragmatic, low-cost solution. The technique uses standard equipment - a 3-way tap - allowing air to be introduced safely and intermittently during drainage to reduce the vacuum effect.
Patients undergoing therapeutic pleural drainage with an indwelling catheter or chest drain will be randomised in a 2:1 ratio to:
Standard drainage care (control group)
Drainage with intermittent controlled air introduction (intervention group)
Air entrainment will be performed by briefly opening the 3-way tap to atmospheric air during drainage up to five times, based on patient discomfort and operator discretion. This aims to equalise pleural pressures, reduce pain, and improve drainage outcomes.
Randomisation is weighted 2:1 towards the intervention group to maximise the number of patients who may benefit, following favourable preliminary data. Both patients and outcome assessors will be blinded to group allocation.
Outcomes collected
Primary Outcomes:
Patient-reported pain scores during drainage - Pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores represent a worse outcome.
Secondary Outcomes:
Volume of pleural fluid drained Number of pleural drainage procedures required Time interval between drainage procedures Incidence of complications (e.g., pneumothorax, re-expansion pulmonary oedema, infection) Reasons for incomplete drainage, including the presence and characteristics of non-expandable lung Patient-reported satisfaction with the drainage procedure
Detailed description
Background and Rationale Air entrainment during pleural effusion drainage may improve pain control, increase fluid removal, and reduce repeat procedures in patients with non-expandable lung (NEL). A local evaluation showed greater pain relief than opioids without adverse events. This study compares air entrainment with standard drainage in NEL.
Objectives
Primary: Determine if air entrainment offers superior pain relief vs standard drainage.
Secondary: Compare fluid volume drained, time to repeat drainage, complication rates (infection, hypotension, air leaks, persistent pain), and patient satisfaction. The questionnaire assessed patient experience across four areas: pre-procedure, during the procedure, post-procedure, and overall care. Each item used 5-point Likert scales. Pre-procedure: Satisfaction with information, understanding, scheduling, and communication. During: Comfort, pain management, staff professionalism, and privacy. Post-procedure: Clarity of aftercare, symptom control, and follow-up. Overall: General satisfaction and likelihood to recommend.
Study Design Prospective, double-blind, randomised intervention study (2:1 ratio) at Cambridge University Hospital. All patients undergoing thoracentesis will be screened; only those with confirmed NEL will be analysed.
Randomisation Patients will be randomised 2:1 (intervention:control) to maximise exposure to the intervention. Allocation is blinded to both patients and VAS assessors.
Population
Inclusion: Adults (≥18) with suspected/confirmed NEL and persistent pleural effusion undergoing thoracentesis; English-speaking and able to consent.
Exclusion: Prior pleurodesis, active infection, baseline VAS ≥5, IPC requirement, contraindications, or inability to consent.
Sample Size 41 NEL patients (27 intervention, 14 control), allowing for 30% dropout. Powered for a 3.4 cm VAS difference (SD 3.1), power = 0.8, alpha = 0.05. Interim analysis after enrolment of 7 control and 14 intervention patients.
Interventions
Intervention: Air introduced into pleural space via 3-way tap to relieve negative pressure (up to five times/session).
Control: Standard thoracentesis, stopped at first discomfort.
Outcomes
Primary Outcome: Pain will be measured using the Visual Analogue Scale (VAS) at four time points: pre-procedure, during the procedure, immediately post-procedure, and 10-15 minutes after the procedure. The VAS is a 10 cm horizontal line with two anchors: 0 represents "no pain" and 10 represents "worst imaginable pain." Patients will be asked to mark the point on the line that corresponds to their pain level, and the distance from the 0 point will be recorded in centimeters to quantify pain intensity.
Secondary Outcomes:
Volume Drained: The total volume of fluid drained will be measured in milliliters (mL).
Time to Repeat Procedure: The time to repeat the procedure, if required, will be recorded in days.
Complications: The occurrence of complications, such as infection, hypotension, air leaks, or persistent pain, will be documented.
Satisfaction: Patient satisfaction will be assessed through a questionnaire, which evaluates various aspects of their experience, including pre-procedure communication, comfort during the procedure, pain management, post-procedure care, and overall experience. Satisfaction will be measured on a Likert scale ranging from "very satisfied" to "very dissatisfied."
Methodology Baseline VAS and clinical data collected. Procedure performed as per allocation. Post-procedure data includes VAS, fluid volume, complications, satisfaction, and follow-up for up to 6 months or until IPC/VATS/death.
Analysis Pain: t-test or Mann-Whitney U, depending on data distribution. Secondary outcomes: t-test, Mann-Whitney U, Chi-square or Fisher's exact depending on data type and distribution.
Analysis will follow the intention-to-treat (ITT) principle, with all patients analysed in their originally assigned groups. Missing data will be addressed using appropriate imputation methods (e.g., multiple imputation), and sensitivity analyses will be conducted to assess the robustness of findings under different missing data assumptions.
Ethics REC Ref: 25/LO/0128 | IRAS ID: 348247 Written informed consent required. Risks: Discomfort, minor complications. Benefits: Possible better pain control and fewer procedures.
Data Management Data stored securely in EPIC with restricted access. Consent forms digitised. Analysis based on anonymised data.
Patient and Public Involvement (PPI) Patient feedback informed the design of patient-facing study materials.
Dissemination Results will be published, presented, shared with stakeholders, and posted on the CUH website. Trial to be registered on ClinicalTrials.gov.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group, randomized controlled trial with a 2:1 allocation ratio (intervention:control). The unequal allocation was chosen to maximise the number of participants receiving the potentially beneficial intervention, following favourable initial data from service evaluation. Randomization will be performed centrally, and both participants and outcome assessors will be blinded to group allocation to minimize bias.
| Arm | Type | Receives |
|---|---|---|
| Standard practice | No intervention | –Fluid drainage will be performed according to standard practice, with cessation of fluid removal at the first sign of patient discomfort to prevent pain. |
| Air Entrainment | Experimental | Procedure: Air Entrainment - intentional introduction of the atmospheric air into the pleural space.During pleural effusion drainage, atmospheric air will be intentionally introduced into the pleural space by opening the 3-way tap to air. This aims to reduce excessive negative pressure, which can create a vacuum effect within the pleural space and is thought to contribute to patient pain during drainage. The tap allows controlled air entry without fluid leakage, helping to minimise pain while maintaining safe drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Air Entrainment - intentional introduction of the atmospheric air into the pleural space.This intervention is distinct in that it uses a standard 3-way tap, already present in routine pleural drainage procedures, to intentionally introduce atmospheric air into the pleural space in a controlled and repeatable manner. Unlike other studies where air entrainment may occur incidentally or as part of more invasive procedures, this method specifically utilises precise manipulation of the tap handle to allow intermittent air entry, aiming to reduce negative intrapleural pressure and associated pain during fluid drainage. Air entry is carefully controlled, can be repeated up to five times per procedure, and does not interfere with fluid drainage or introduce additional equipment or complexity. | Procedure or surgery | Air Entrainment |
Primary outcome
Pain Relief
Time frame: From the procedure start until 15 minutes after the procedure
Pain will be measured using the Visual Analog Scale (VAS) before, during, and immediately after the drainage procedure and again 10-15 minutes later to capture the progression of relief.
5 secondary outcomes
Drainage Volumes
Time frame: Up to 6 months post-randomization
Number of pleural drainage procedures required.
Time frame: Up to 6 months post-randomization
Time interval between drainage procedures.
Time frame: Up to 6 months post-randomization
Complications
Time frame: Up to 6 months post-randomization
Patient Satisfaction
Time frame: At each in-person visit, through study completion (6 months)
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 7 May 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that may be shared includes pain scores recorded during the procedure, the volume of pleural effusion drained, any complications occurring during or after the procedure, and details of incomplete drainage, including evidence of and reasons for trapped lung. This data may be shared to support further research conducted by both commercial and non-commercial organisations, within the UK and internationally.
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.
Jurgen Herre, PhD 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 Air Entrainment - intentional introduction of the atmospheric air into the pleural space. in people with Non-expandable Lung and Trapped Lung, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 6 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 7 May 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 United Kingdom. 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 Emilia M SWIETLIK, MD PhD (+447736750560, e.swietlik@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relief (time frame: From the procedure start until 15 minutes after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2025.