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

NCT ID: NCT06471608

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2030-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: 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).

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

Group Type: EXPERIMENTAL

Ambulatory management

Intervention Type: 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.

Interventions

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 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.

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU de Besançon - Hôpital Jean Minjoz

Besançon, , France

Hôpital Pellegrin - CHU de Bordeaux

Bordeaux, , France

CHU de Grenoble - Hôpital Michallon

La Tronche, , France

Hôpital Saint Louis - AP-HP

Paris, , France

Hôpital Universitaire Pitié Salpétrière AP-HP

Paris, , France

Hôpital de la Milétrie - CHU de Poitiers

Poitiers, , France

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

Central Contacts

Sabrina GARNIER-KEPKA, MD

Role: CONTACT

Sabrina.GARNIER-KEPKA@chru-strasbourg.fr

3 69 55 13 35 ext. +33

Facility Contacts

Tania MARX, MD

Role: primary

tania.marx@univ-fcomte.fr

+33 6 75 95 20 46

Cédric GIL-JARDINE, MD

Role: primary

cedric.gil-jardine@chu-bordeaux.fr

+33 5 56 79 56 79

Damien VIGLINO, MD

Role: primary

DViglino@chu-grenoble.fr

+33 4 76 76 54 32

Olivier PEYRONY, MD

Role: primary

olivier.peyrony@aphp.fr

+33 1 42 49 49 49

Anne-Laure PHILIPPON PHILIPPON, MD

Role: primary

annelaurephilippon@aphp.fr

+33 1 84 82 76 51

Nicolas MARJANOVIC, MD

Role: primary

Nicolas.MARJANOVIC@chu-poitiers.fr

+33 5 49 44 44 44

Sabrina GARNIER-KEPKA, Professor

Role: primary

Sabrina.GARNIER-KEPKA@chru-strasbourg.fr

+33 3 69 55 13 35

Other Identifiers

9155

Identifier Type: -

Identifier Source: org_study_id