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

Official title

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

Overview

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.

Interventions

• Other 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
• 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).

Primary outcome measures

• Quality of life at 6 months [Time frame: 6 months]

Secondary outcome measures (12)

• 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]
• Proportion of patients having benefited from an exclusive outpatient management (patients not requiring hospitalisation during the ambulatory approach) [Time frame: Day 6]
• Assessment of Pain [Time frame: Day 0, Day 2, Day 4, Day 6 and monthly]
• Assessment of Dyspnea according to the mMRC classification [Time frame: Day 0, Day 2, Day 4, Day 6 and monthly]
• Complication rates (major and minor) in the 2 groups [Time frame: Day 2, 4, 6, 1 month and 1 year]
• Pneumothorax Recurrence Rate [Time frame: at 1 year]
• Patient satisfaction assessed by SAPS (The Short Assessment of Patient Satisfaction) questionnaire [Time frame: Day 0, 1 month, 6 months and 1 year]
• Patient preference (coded from 0 to 5): ambulatory/non-ambulatory [Time frame: Day 0, 1 month, 6 months and 1 year]
• Anxiety assessed by the State-Trait Anxiety Inventory (STAI) [Time frame: Day 0, 1 month, 6 months and 1 year.]
• Quality of life assessed by SF-36 (The Short Form (36) Health Survey) [Time frame: at 1 month and 1 year]
• Ambulatory strategy implementation criteria : Penetrance [Time frame: At 1 year]
• Ambulatory strategy implementation criteria : Acceptability [Time frame: At 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 7 centers

• CHRU de Besançon - Hôpital Jean Minjoz — Besançon
• Hôpital Pellegrin - CHU de Bordeaux — Bordeaux
• CHU de Grenoble - Hôpital Michallon — La Tronche
• Hôpital Saint Louis - AP-HP — Paris
• Hôpital Universitaire Pitié Salpétrière AP-HP — Paris
• Hôpital de la Milétrie - CHU de Poitiers — Poitiers
• Hôpitaux Universitaires de Strasbourg — Strasbourg

Publications

• 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 s PMID 41448686

Identifiers

NCT: NCT06471608 · 9155

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗