Primary Spontaneous PneumothoraxEFFI-PNONCT06471608
Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life
A study testing Ambulatory management in people with Primary Spontaneous Pneumothorax and Quality of Life, run by University Hospital, Strasbourg, France at 7 sites in France.
Trial summary
Outpatient treatment of Primary Spontaneous Pneumothorax (PSP) compared to usual inpatient management could improve quality of care and represent a more efficient, generalizable and sustainable strategy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Primary Spontaneous Pneumothorax, Quality of Life, Ambulatory Care
- What is being tested?
- Ambulatory management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Dec 2025to Jul 2030
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 to 50 years presenting to the emergency department with a 1st episode of right or left primary spontaneous pneumothorax (PSP) of large abundance diagnosed by chest X-ray or CT scan defined according to British Thoracic Society (BTS) recommendations as a detachment greater than 2 cm over the entire height of the axillary line.
- Patient living less than an hour from hospital and able to be accompanied for the first 48 hours
- Patient able to understand the aims and risks of the research and to give informed, dated and signed consent
- Patient with Internet access and able to complete online questionnaires
- Patient affiliated to or benefiting from a social health insurance
Who cannot join
- Small pneumothorax (≤ 2cm)
- Suffocating pneumothorax defined by the presence of signs of respiratory distress or hemodynamic failure with indication for emergency exsufflation
- Patient on emergency oxygen or long-term oxygen therapy
- Traumatic pneumothorax
- Secondary spontaneous pneumothorax
- Bilateral pneumothorax
Show all 13Show fewer
- Associated fluid effusion
- Risk-benefit balance unfavorable to outpatient treatment (comorbidities, isolated patient, difficulty understanding monitoring instructions)
- Patient living more than one hour from hospital
- Patients living alone or unable to be accompanied on discharge for the first 48 hours
- Patients under legal protection
- Pregnant or breast-feeding women
- Patient participating in a therapeutic interventional clinical trial or in a period of exclusion linked to previous participation in a clinical trial
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
CHRU de Besançon - Hôpital Jean Minjoz
Besançon, 25030
Tania MARX, MD, +33 6 75 95 20 46, tania.marx@univ-fcomte.fr
Hôpital Pellegrin - CHU de Bordeaux
Bordeaux, 33000
Cédric GIL-JARDINE, MD, +33 5 56 79 56 79, cedric.gil-jardine@chu-bordeaux.fr
CHU de Grenoble - Hôpital Michallon
La Tronche, 38700
Damien VIGLINO, MD, +33 4 76 76 54 32, DViglino@chu-grenoble.fr
Hôpital Saint Louis - AP-HP
Paris, 75475
Olivier PEYRONY, MD, +33 1 42 49 49 49, olivier.peyrony@aphp.fr
Hôpital Universitaire Pitié Salpétrière AP-HP
Paris, 75651
Anne-Laure PHILIPPON PHILIPPON, MD, +33 1 84 82 76 51, annelaurephilippon@aphp.fr
Hôpital de la Milétrie - CHU de Poitiers
Poitiers, 86021
Nicolas MARJANOVIC, MD, +33 5 49 44 44 44, Nicolas.MARJANOVIC@chu-poitiers.fr
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Sabrina GARNIER-KEPKA, Professor, +33 3 69 55 13 35, Sabrina.GARNIER-KEPKA@chru-strasbourg.fr
About this study
Official title: Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life: a Randomized Clinical Trial
Outpatient treatment of Primary Spontaneous Pneumothorax (PSP) compared to usual inpatient management could improve quality of care and represent a more efficient, generalizable and sustainable strategy.
This multicenter, cluster-controlled, randomized interventional study with stepped wedge implementation will evaluate the impact on quality of life (between inclusion, after drain placement, and 6 months) of an ambulatory strategy for the management of large abundance primary spontaneous pneumothorax in the emergency department, compared with usual care.
- Being tested
- Ambulatory management, Standard Care
- Keywords
- Chest tube drainage, Primary spontaneous pneumothorax, Ambulatory management, Quality of life
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory managementOther
- Chest tube drainage in emergency department (Furhmann drain connected to Heimlich valve), connected to suction system at -5 to -10 cm H2O until bubbling stops
- Follow-up imaging at 4 hours (chest X-ray or low-dose CT scan, depending on management practices in the centers)
- if the pneumothorax is still very large, or if clinical tolerance is unsatisfactory (dyspnea, unrelieved pain, abnormal vital parameters), the patient should be admitted to hospital
- if the lung is in the process of reattachment and a minimal detachment persists, and clinical tolerance is good (assessed on vital parameters, with oxygen saturation above 98%, good hemodynamic stability and pain relieved by analgesics), the patient may be discharged home.
Standard CareOther
Hospitalisation in a hospital department (pulmonology, thoracic surgery, short-stay emergency unit, critical care, according to the usual pathway of the center in which the patient is included).
In-hospital monitoring until complete resolution of pneumothorax and drain removal (average 4-6 days).
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Chest tube drainage with hospital management
* chest tube drainage (with a straight or pigtail drain, less than ≤ 14 Fr in diameter, inserted using the Seldinger versus Seldinger technique, or using the standard drainage technique with an internal mandrel drain), followed by post-procedure imaging prior to transfer to the department, in accordance with standard practice (chest X-ray or low-dose CT scan, depending on management practices at the center).
* Hospitalisation in a hospital department (pulmonology, thoracic surgery, short-stay emergency unit, critical care, according to the usual pathway of the center in which the patient is included).
* In-hospital monitoring until complete resolution of pneumothorax and drain removal (average 4-6 days). Receives: Other: Standard Care |
| Ambulatory management | Experimental | - Chest tube drainage in emergency department (Furhmann drain connected to Heimlich valve), connected to suction system at -5 to -10 cm H2O until bubbling stops and ambulatory management after monitoring in the emergency department Receives: Other: Ambulatory management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life at 6 months
Evaluate the impact on quality of life (between inclusion, after drain placement, and 6 months) of an ambulatory strategy for the management of large abundance primary spontaneous pneumothorax in the emergency department, compared with usual care, using the Short Form (36) Health Survey (The lower the score the more disability)
Measured: 6 months
Secondary outcomes (23)
Success rate of the strategy as measured by pulmonary expansion (lung reattachment on X-ray / CT scan) the latest by the investigator who performed the drainage procedure
Measured: Day 6
Proportion of patients having benefited from an exclusive outpatient management (patients not requiring hospitalisation during the ambulatory approach)
Measured: Day 6
Assessment of Pain
Pain assessed on a numerical scale (rated from 0 to 10), 0 being the lowest pain and 10 being the maximum pain
Measured: Day 0, Day 2, Day 4, Day 6 and monthly
Assessment of Dyspnea according to the mMRC classification
mMRC classification (0 to 4), 0 being no discomfort and 4 shortness of breath for simple acts of daily living.
Measured: Day 0, Day 2, Day 4, Day 6 and monthly
Complication rates (major and minor) in the 2 groups
- Minor (bleeding at insertion site, tube kinking, pain limiting inspiratory movements, subcutaneous emphysema, unsightly scar)
- Major (hemothorax due to lesion of the vasculonervous bundle, bubbling (leakage) at the tube insertion site, accidental removal, perforation of an organ (lung, spleen, etc.), local abscess, iatrogenic pneumothorax on tube removal, pulmonary re-expansion edema).
Measured: Day 2, 4, 6, 1 month and 1 year
Pneumothorax Recurrence Rate
Incidence of recurrence in both groups.
Measured: at 1 year
Patient satisfaction assessed by SAPS (The Short Assessment of Patient Satisfaction) questionnaire
Measured: Day 0, 1 month, 6 months and 1 year
Patient preference (coded from 0 to 5): ambulatory/non-ambulatory
Preference will be assessed as follows: Each patient will be asked to code their opinion of outpatient management from 0 to 5, and their opinion of inpatient management from 0 to 5, whatever their randomization group (0 being the worst opinion of the strategy, and 5 a very positive opinion of the strategy).
Measured: Day 0, 1 month, 6 months and 1 year
Anxiety assessed by the State-Trait Anxiety Inventory (STAI)
Measured: Day 0, 1 month, 6 months and 1 year.
Quality of life assessed by SF-36 (The Short Form (36) Health Survey)
Measured: at 1 month and 1 year
Ambulatory strategy implementation criteria : Penetrance
Assesses how widely the device is deployed within a service and whether it is transferable to other contexts. Studied through focus groups with professionals on adoption, institutional changes, and scalability
Measured: At 1 year
Ambulatory strategy implementation criteria : Acceptability
Represents how patients and healthcare professionals perceive the benefits and limits of the device in care and relationships. Evaluated through semi-structured interviews (patients' experiences) and focus groups (care practices)
Measured: At 1 year
Ambulatory strategy implementation criteria : Appropriation
Concerns the perceived added value of the device in care management and patient-professional relations. Measured via interviews (perceived value/efficacy) and focus groups (use in ambulatory vs hospital care).
Measured: At 1 year
Ambulatory strategy implementation criteria : Adoption
Refers to whether professionals and patients integrate or learn new practices with the device. Assessed by interviews on experiences and focus groups on care practices.
Measured: At 1 year
Ambulatory strategy implementation criteria : Feasibility
Looks at the practical experience of using the device in daily care and the caregiver-patient relationship. Explored in focus groups with healthcare professionals discussing usability and practicality.
Measured: At 1 year
Ambulatory strategy implementation criteria : Fidelity
Examines whether the device is applied as initially intended, and the perceived quality of its implementation. Assessed through focus groups reflecting on adherence to goals and strategies in care delivery.
Measured: At 1 year
Ambulatory strategy implementation criteria : Cost of implementation
Considers the economic impact for patients and the health system (direct and indirect costs). Evaluated through quantitative patient data: hospital stays, readmissions, and insurance compensation.
Measured: At 1 year
Ambulatory strategy implementation criteria : Durability
Relates to maintaining the device over time and integrating it into routine care across hospitals. Evaluated via interviews (patients' risk perception, care continuity) and focus groups (staff reflection on long-term use).
Measured: At 1 year
Duration of emergency care in the 2 groups
Measured: 1 year
Estimation of costs associated with each strategy
Total direct and indirect healthcare costs associated with each management strategy.
Measured: at 1 year
Estimation of the difference in QALYs gained using a mixed model
Measured: at 1 year
Incremental cost-utility ratio, defined as the difference in costs divided by the difference in utility estimated by the EQ-5D scores obtained by mapping from the SF-36
with a valuation of the scores obtained with the utilities published for the French population
Measured: at 1 year
Budgetary impact of a national roll-out scenario for the ambulatory care strategy from the perspective of the French Health Insurance
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completionJul 2030 (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 Primary Spontaneous PneumothoraxStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471608
- Sponsor's protocol ID
- 9155
- Acronym
- EFFI-PNO
- Status last verified
- Nov 2025
- First submitted
- 14 Jun 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kepka S, Wilme V, Duracinsky M, Matau C, Nze Ossima A, Gil Jardine C, Le Borgne P, Marjanovic N, Marx T, Ohana M, Peyrony O, Philippon AL, Viglino D, Chenou A, Clere-Jehl R, Bilbault P, Durand-Zaleski I, Sauleau EA. Ambulatory management of primary spontaneous pneumothorax in the emergency department: EFFI-PNO protocol - a multicentre, cluster-controlled, stepped-wedge, randomised interventional study. BMJ Open. 2025 Dec 24;15(12):e106739. doi: 10.1136/bmjopen-2025-106739.
PubMed 41448686
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06471608
- Acronym / sponsor ID
- EFFI-PNO / 9155
- Keywords
- Chest tube drainage, Primary spontaneous pneumothorax, Ambulatory management, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 24 Jun 2024 (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.
Outpatient treatment of Primary Spontaneous Pneumothorax (PSP) compared to usual inpatient management could improve quality of care and represent a more efficient, generalizable and sustainable strategy.
This multicenter, cluster-controlled, randomized interventional study with stepped wedge implementation will evaluate the impact on quality of life (between inclusion, after drain placement, and 6 months) of an ambulatory strategy for the management of large abundance primary spontaneous pneumothorax in the emergency department, compared with usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: Standard CareChest tube drainage with hospital management * chest tube drainage (with a straight or pigtail drain, less than ≤ 14 Fr in diameter, inserted using the Seldinger versus Seldinger technique, or using the standard drainage technique with an internal mandrel drain), followed by post-procedure imaging prior to transfer to the department, in accordance with standard practice (chest X-ray or low-dose CT scan, depending on management practices at the center). * Hospitalisation in a hospital department (pulmonology, thoracic surgery, short-stay emergency unit, critical care, according to the usual pathway of the center in which the patient is included). * In-hospital monitoring until complete resolution of pneumothorax and drain removal (average 4-6 days). |
| Ambulatory management | Experimental | Other: Ambulatory management- Chest tube drainage in emergency department (Furhmann drain connected to Heimlich valve), connected to suction system at -5 to -10 cm H2O until bubbling stops and ambulatory management after monitoring in the emergency department |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 50 years presenting to the emergency department with a 1st episode of right or left primary spontaneous pneumothorax (PSP) of large abundance diagnosed by chest X-ray or CT scan defined according to British Thoracic Society (BTS) recommendations as a detachment greater than 2 cm over the entire height of the axillary line.
- Patient living less than an hour from hospital and able to be accompanied for the first 48 hours
- Patient able to understand the aims and risks of the research and to give informed, dated and signed consent
- Patient with Internet access and able to complete online questionnaires
- Patient affiliated to or benefiting from a social health insurance
Key exclusion criteria (13 listed)
- Small pneumothorax (≤ 2cm)
- Suffocating pneumothorax defined by the presence of signs of respiratory distress or hemodynamic failure with indication for emergency exsufflation
- Patient on emergency oxygen or long-term oxygen therapy
- Traumatic pneumothorax
- Secondary spontaneous pneumothorax
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 |
|---|---|---|
| Ambulatory management* Chest tube drainage in emergency department (Furhmann drain connected to Heimlich valve), connected to suction system at -5 to -10 cm H2O until bubbling stops * Follow-up imaging at 4 hours (chest X-ray or low-dose CT scan, depending on management practices in the centers) * if the pneumothorax is still very large, or if clinical tolerance is unsatisfactory (dyspnea, unrelieved pain, abnormal vital parameters), the patient should be admitted to hospital * if the lung is in the process of reattachment and a minimal detachment persists, and clinical tolerance is good (assessed on vital parameters, with oxygen saturation above 98%, good hemodynamic stability and pain relieved by analgesics), the patient may be discharged home. | Other | Ambulatory management |
| Standard CareHospitalisation in a hospital department (pulmonology, thoracic surgery, short-stay emergency unit, critical care, according to the usual pathway of the center in which the patient is included). In-hospital monitoring until complete resolution of pneumothorax and drain removal (average 4-6 days). | Other | Standard care |
Primary outcome
Quality of life at 6 months
Time frame: 6 months
Evaluate the impact on quality of life (between inclusion, after drain placement, and 6 months) of an ambulatory strategy for the management of large abundance primary spontaneous pneumothorax in the emergency department, compared with usual care, using the Short Form (36) Health Survey (The lower the score the more disability)
23 secondary outcomes
Success rate of the strategy as measured by pulmonary expansion (lung reattachment on X-ray / CT scan) the latest by the investigator who performed the drainage procedure
Time frame: Day 6
Proportion of patients having benefited from an exclusive outpatient management (patients not requiring hospitalisation during the ambulatory approach)
Time frame: Day 6
Assessment of Pain
Time frame: Day 0, Day 2, Day 4, Day 6 and monthly
Assessment of Dyspnea according to the mMRC classification
Time frame: Day 0, Day 2, Day 4, Day 6 and monthly
Complication rates (major and minor) in the 2 groups
Time frame: Day 2, 4, 6, 1 month and 1 year
Pneumothorax Recurrence Rate
Time frame: at 1 year
Patient satisfaction assessed by SAPS (The Short Assessment of Patient Satisfaction) questionnaire
Time frame: Day 0, 1 month, 6 months and 1 year
Patient preference (coded from 0 to 5): ambulatory/non-ambulatory
Time frame: Day 0, 1 month, 6 months and 1 year
Anxiety assessed by the State-Trait Anxiety Inventory (STAI)
Time frame: Day 0, 1 month, 6 months and 1 year.
Quality of life assessed by SF-36 (The Short Form (36) Health Survey)
Time frame: at 1 month and 1 year
Ambulatory strategy implementation criteria : Penetrance
Time frame: At 1 year
Ambulatory strategy implementation criteria : Acceptability
Time frame: At 1 year
Ambulatory strategy implementation criteria : Appropriation
Time frame: At 1 year
Ambulatory strategy implementation criteria : Adoption
Time frame: At 1 year
Ambulatory strategy implementation criteria : Feasibility
Time frame: At 1 year
Ambulatory strategy implementation criteria : Fidelity
Time frame: At 1 year
Ambulatory strategy implementation criteria : Cost of implementation
Time frame: At 1 year
Ambulatory strategy implementation criteria : Durability
Time frame: At 1 year
Duration of emergency care in the 2 groups
Time frame: 1 year
Estimation of costs associated with each strategy
Time frame: at 1 year
Estimation of the difference in QALYs gained using a mixed model
Time frame: at 1 year
Incremental cost-utility ratio, defined as the difference in costs divided by the difference in utility estimated by the EQ-5D scores obtained by mapping from the SF-36
Time frame: at 1 year
Budgetary impact of a national roll-out scenario for the ambulatory care strategy from the perspective of the French Health Insurance
Time frame: at 1 year
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 26 Nov 2025.
- Derived from this study: PubMed 41448686Kepka S, Wilme V, Duracinsky M, Matau C, Nze Ossima A, Gil Jardine C, Le Borgne P, Marjanovic N, Marx T, Ohana M, Peyrony O, Philippon AL, Viglino D, Chenou A, Clere-Jehl R, Bilbault P, Durand-Zaleski I, Sauleau EA. Ambulatory management of primary spontaneous pneumothorax in the emergency department: EFFI-PNO protocol - a multicentre, cluster-controlled, stepped-wedge, randomised interventional study. BMJ Open. 2025 Dec 24;15(12):e106739. doi: 10.1136/bmjopen-2025-106739.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory management in people with Primary Spontaneous Pneumothorax and Quality of Life, run by University Hospital, Strasbourg, France at 7 sites in France.
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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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 Sabrina GARNIER-KEPKA, MD (3 69 55 13 35 ext. +33, Sabrina.GARNIER-KEPKA@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life at 6 months (time frame: 6 months). 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 NCT06471608, 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 26 Nov 2025.