Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life (EFFI-PNO)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Ambulatory Care; Primary Spontaneous Pneumothorax; Chest Tube
• Intervention / Treatment: Other: Standard Care; Other: Ambulatory management

• Study Type: Interventional
• Enrollment (Estimated): 386
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabrina GARNIER-KEPKA, MD; Phone Number: +33 3 69 55 13 35; Email: Sabrina.GARNIER-KEPKA@chru-strasbourg.fr

Study Locations

• France
  • Besançon, France, 25030
    • CHRU de Besancon - Hopital Jean Minjoz
    • Contact: Tania MARX, MD; Phone Number: +33 6 75 95 20 46; Email: tania.marx@univ-fcomte.fr
  • Bordeaux, France, 33000
    • Hôpital Pellegrin - CHU de Bordeaux
    • Contact: Cédric GIL-JARDINE, MD; Phone Number: +33 5 56 79 56 79; Email: cedric.gil-jardine@chu-bordeaux.fr
  • La Tronche, France, 38700
    • CHU de Grenoble - Hôpital Michallon
    • Contact: Damien VIGLINO, MD; Phone Number: +33 4 76 76 54 32; Email: DViglino@chu-grenoble.fr
  • Paris, France, 75475
    • Hôpital Saint Louis - AP-HP
    • Contact: Olivier PEYRONY, MD; Phone Number: +33 1 42 49 49 49; Email: olivier.peyrony@aphp.fr
  • Paris, France, 75651
    • Hôpital Universitaire Pitié Salpétrière AP-HP
    • Contact: Anne-Laure PHILIPPON PHILIPPON, MD; Phone Number: +33 1 84 82 76 51; Email: annelaurephilippon@aphp.fr
  • Poitiers, France, 86021
    • Hôpital de la Milétrie - CHU de Poitiers
    • Contact: Nicolas MARJANOVIC, MD; Phone Number: +33 5 49 44 44 44; Email: nicolas.MARJANOVIC@chu-poitiers.fr
  • Strasbourg, France, 67091
    • Hôpitaux Universitaires de Strasbourg
    • Contact: Sabrina GARNIER-KEPKA, Professor; Phone Number: +33 3 69 55 13 35; Email: Sabrina.GARNIER-KEPKA@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care; 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).	Other: Standard Care; 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).
Experimental: 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	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; 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 hospitalif 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Budgetary impact of a national roll-out scenario for the ambulatory care strategy from the perspective of the French Health Insurance		at 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 : 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
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
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)		Day 6
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).	Day 2, 4, 6, 1 month and 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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Chest tube drainage; Primary spontaneous pneumothorax; Ambulatory management
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 9155

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No