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NCT Number: NCT06471608

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

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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Key information

Conditions

Primary Spontaneous Pneumothorax Ambulatory Care Chest Tube Pleural Diseases Pneumothorax Quality of Life Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Besançon - Hôpital Jean Minjoz, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambulatory management

Other
  • 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 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).

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Proportion of patients having benefited from an exclusive outpatient management (patients not requiring hospitalisation during the ambulatory approach)

    Time frame: Day 6

  3. Assessment of Pain

    Time frame: 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

  4. Assessment of Dyspnea according to the mMRC classification

    Time frame: 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.

  5. Complication rates (major and minor) in the 2 groups

    Time frame: Day 2, 4, 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).

  6. Pneumothorax Recurrence Rate

    Time frame: at 1 year

    Incidence of recurrence in both groups.

  7. Patient satisfaction assessed by SAPS (The Short Assessment of Patient Satisfaction) questionnaire

    Time frame: Day 0, 1 month, 6 months and 1 year

  8. Patient preference (coded from 0 to 5): ambulatory/non-ambulatory

    Time frame: 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).

  9. Anxiety assessed by the State-Trait Anxiety Inventory (STAI)

    Time frame: Day 0, 1 month, 6 months and 1 year.

  10. Quality of life assessed by SF-36 (The Short Form (36) Health Survey)

    Time frame: at 1 month and 1 year

  11. Ambulatory strategy implementation criteria : Penetrance

    Time frame: 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

  12. Ambulatory strategy implementation criteria : Acceptability

    Time frame: 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)

  13. Ambulatory strategy implementation criteria : Appropriation

    Time frame: 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).

  14. Ambulatory strategy implementation criteria : Adoption

    Time frame: 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.

  15. Ambulatory strategy implementation criteria : Feasibility

    Time frame: 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.

  16. Ambulatory strategy implementation criteria : Fidelity

    Time frame: 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.

  17. Ambulatory strategy implementation criteria : Cost of implementation

    Time frame: 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.

  18. Ambulatory strategy implementation criteria : Durability

    Time frame: 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).

  19. Duration of emergency care in the 2 groups

    Time frame: 1 year

  20. Estimation of costs associated with each strategy

    Time frame: at 1 year

    Total direct and indirect healthcare costs associated with each management strategy.

  21. Estimation of the difference in QALYs gained using a mixed model

    Time frame: at 1 year

  22. 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

    with a valuation of the scores obtained with the utilities published for the French population

  23. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sabrina GARNIER-KEPKA, MD

CONTACT

[email protected]

3 69 55 13 35 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life: a Randomized Clinical Trial

Acronym: EFFI-PNO

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jun 24, 2024
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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