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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator | Chest tube drainage with hospital management
|
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory management | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 6 | |
| Proportion of patients having benefited from an exclusive outpatient management (patients not requiring hospitalisation during the ambulatory approach) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabrina GARNIER-KEPKA, MD | Contact | 3 69 55 13 35 | +33 | Sabrina.GARNIER-KEPKA@chru-strasbourg.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Besançon - Hôpital Jean Minjoz | Besançon | 25030 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41448686 | Derived | 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. |
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|
| Standard Care | Other | 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). |
|
| 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 | 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. | Day 0, Day 2, Day 4, Day 6 and monthly |
| Complication rates (major and minor) in the 2 groups |
| Day 2, 4, 6, 1 month and 1 year |
| Pneumothorax Recurrence Rate | Incidence of recurrence in both groups. | at 1 year |
| Patient satisfaction assessed by SAPS (The Short Assessment of Patient Satisfaction) questionnaire | 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). | Day 0, 1 month, 6 months and 1 year |
| Anxiety assessed by the State-Trait Anxiety Inventory (STAI) | Day 0, 1 month, 6 months and 1 year. |
| Quality of life assessed by SF-36 (The Short Form (36) Health Survey) | 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 | 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) | 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). | 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. | 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. | 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. | 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. | 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). | At 1 year |
| Duration of emergency care in the 2 groups | 1 year |
| Estimation of costs associated with each strategy | Total direct and indirect healthcare costs associated with each management strategy. | at 1 year |
| Estimation of the difference in QALYs gained using a mixed model | 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 | at 1 year |
| Budgetary impact of a national roll-out scenario for the ambulatory care strategy from the perspective of the French Health Insurance | at 1 year |
| Hôpital Pellegrin - CHU de Bordeaux | Bordeaux | 33000 | France |
|
| CHU de Grenoble - Hôpital Michallon | La Tronche | 38700 | France |
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| Hôpital Saint Louis - AP-HP | Paris | 75475 | France |
|
| Hôpital Universitaire Pitié Salpétrière AP-HP | Paris | 75651 | France |
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| Hôpital de la Milétrie - CHU de Poitiers | Poitiers | 86021 | France |
|
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
|
| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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