Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life

Not Applicable

Not yet recruiting

• Conditions: Ambulatory Care; Chest Tube; Primary Spontaneous Pneumothorax; Quality of Life

• Registration Number: NCT06471608
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-20
• Study First Posted: 2024-06-24
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-22
• Last Update Posted: 2025-08-29
• Study Start: 2025-09-01
• Primary Completion: 2030-04-01
• Study Completion: 2030-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 387

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life at 6 months	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)

Secondary Outcome Measures

Name	Time	Method
Rate of patients included in the outpatient group who benefited from complete outpatient management (no need for hospitalization between inclusion and lung reattachment)	Day 6
Assessment of Pain	Day 0, Day 2, Day 4, Day 6 and monthly	Pain assessed on a numerical scale (rated from 0 to 10), 0 being the lowest pain and 10 being the maximum pain
Assessment of Dyspnea according to the mMRC classification	Day 0, Day 2, Day 4, Day 6 and monthly	mMRC classification (0 to 4), 0 being no discomfort and 4 shortness of breath for simple acts of daily living.
Complication rates (major and minor) in the 2 groups	Day 6, 1 month and 1 year	* 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).
Pneumothorax Recurrence Rate	at 1 year	Incidence of recurrence in both groups.
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	at 1 year
Ambulatory strategy implementation criteria : Penetrance	At 1 year	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
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 the difference in QALYs gained using a mixed model	at 1 year
Ambulatory strategy implementation criteria : Feasibility	At 1 year	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.
Ambulatory strategy implementation criteria : Fidelity	At 1 year	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.
Ambulatory strategy implementation criteria : Durability	At 1 year	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).
Success rate of the strategy (lung reattachment on X-ray / CT scan) the latest by the investigator who performed the drainage procedure	Day 6
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	Day 0, 1 month, 6 months and 1 year	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).
Estimation of costs associated with each strategy	at 1 year	Total direct and indirect healthcare costs associated with each management strategy.
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 : Acceptability	At 1 year	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)
Ambulatory strategy implementation criteria : Appropriation	At 1 year	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).
Ambulatory strategy implementation criteria : Cost of implementation	At 1 year	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.
Ambulatory strategy implementation criteria : Adoption	At 1 year	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.