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

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Jun 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how outpatient treatment for a condition called Primary Spontaneous Pneumothorax (PSP) affects patients' quality of life. PSP occurs when air leaks into the space between the lung and chest wall, often leading to chest pain and difficulty breathing. The goal of the trial is to find out if managing this condition in an outpatient setting—meaning patients can go home instead of staying in the hospital—can improve their overall well-being compared to the usual hospital treatment. Participants will be assessed at three points: when they start the study, right after receiving treatment, and six months later.

To be eligible for this trial, participants must be between 18 and 50 years old and have their first experience with a large PSP, confirmed by a chest X-ray or CT scan. They should live within an hour of the hospital and have someone to help them for the first two days after treatment. Participants will need to be able to understand the study and complete online questionnaires about their experience. It's important to note that certain conditions, like a small pneumothorax or severe respiratory issues, would exclude someone from participating. Overall, this trial aims to explore a more efficient way to treat PSP while ensuring that patients have the support they need for recovery.

Gender

ALL

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