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

NCT06471608 | Not Yet Recruiting

• 1 other identifier: 9155
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 7

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.

Conditions

Primary Spontaneous Pneumothorax; Quality of Life; Ambulatory Care; Chest Tube

Keywords

Chest tube drainage; Primary spontaneous pneumothorax; Ambulatory management; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 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

  Day 6

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

  Day 6

• Assessment of Pain

  Day 0, Day 2, Day 4, Day 6 and monthly

• Assessment of Dyspnea according to the mMRC classification

  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

Study Arms (2)

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).

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

Other: Ambulatory management

Interventions

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.

Ambulatory management

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).

Standard care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (7)

CHRU de Besançon - Hôpital Jean Minjoz

Besançon, 25030, France

Location

Hôpital Pellegrin - CHU de Bordeaux

Bordeaux, 33000, France

Location

CHU de Grenoble - Hôpital Michallon

La Tronche, 38700, France

Location

Hôpital Saint Louis - AP-HP

Paris, 75475, France

Location

Hôpital Universitaire Pitié Salpétrière AP-HP

Paris, 75651, France

Location

Hôpital de la Milétrie - CHU de Poitiers

Poitiers, 86021, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (1)

• 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.

  PMID: 41448686 DERIVED

MeSH Terms

Conditions

Pneumothorax

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Sabrina GARNIER-KEPKA, MD

CONTACT

3 69 55 13 35; Sabrina.GARNIER-KEPKA@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 24, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

FR (7)