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

University Hospital, Strasbourg, France

Status: Not yet enrolling

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

Treatments: Other: Standard Care; Other: Ambulatory management

Study type: Interventional

Funder types: Other

Identifiers

NCT06471608

9155

Details and patient eligibility

About

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.

Enrollment: 386 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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386 participants in 2 patient groups

Standard care

Active Comparator group

Description:

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).

Treatment:

Other: Standard Care

Ambulatory management

Experimental group

Description:

\- 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

Treatment:

Other: Ambulatory management