Conservative Management in Primary Spontaneous Pneumothorax: a Multicenter Randomized Non-inferiority Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCorporacion Parc Tauli
About this trial
The goal of this randomized clinical trial is to find out whether a conservative management strategy (active observation without an initial invasive procedure) can treat as effectively as the standard treatment with chest tube drainage in adults with a large primary spontaneous pneumothorax who are clinically stable. Participants include men and women 18 to 60 years old with a lung collapse ≥30% (by Collins method).
The main questions are:
* Is conservative management not inferior to chest tube drainage for achieving complete lung re-expansion at 8 weeks (on chest X-ray)? * What are the differences between the two strategies in complications, recurrence at 2 years, quality of life, length of hospital stay, number of additional procedures, and healthcare costs?
Comparison groups:
* Conservative management: in-hospital observation with a control chest X-ray no earlier than 4 hours; if the person remains stable, discharge home with scheduled outpatient follow-up and serial X-rays until resolution. * Standard treatment (chest tube): chest tube placement and hospital admission; discharge based on clinical progress with routine outpatient follow-up.
Researchers will compare both groups to see whether conservative management works just as well to resolve the pneumothorax at 8 weeks and whether it leads to fewer complications, shorter hospital stays, better quality of life, and lower costs.
What will participants be asked to do? Review the participant information sheet and sign informed consent.
Be randomized by computer (REDCap) to either conservative management or chest tube drainage.
Depending on the assigned group:
* Conservative group: remain under observation initially, have a chest X-ray at ≥4 hours; if still stable, go home with clinic visits (about 1 week after discharge and then every \~2 weeks) until the pneumothorax has resolved. * Chest tube group: undergo chest tube insertion, stay in the hospital, and attend routine outpatient follow-up after discharge.
Undergo chest X-rays interpreted by the clinical team (with centralized review procedures).
Complete brief symptom assessments, quality-of-life questionnaires (e.g., EQ-5D-5L), and attend follow-up visits or phone calls for up to 2 years to check for recurrences.
This is a multicenter study conducted in several hospitals in Spain. The planned sample size is 436 participants (218 per group), with a non-inferiority margin of 5% and the primary assessment at 8 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: >18 and ≤60 years at the time of enrollment.
Diagnosis: Primary spontaneous pneumothorax of large size (lung collapse ≥30% by the Collins method on chest X-ray).
Episode type: Any episode of primary spontaneous pneumothorax.
Clinical stability suitable for observation without immediate intervention: Systolic BP >90 mmHg, heart rate <140 bpm, oxygen saturation >90% (with supplemental oxygen if needed), respiratory rate 15-30 breaths/min.
Disqualifiers
Pre-existing lung disease that may predispose to pneumothorax (e.g., COPD, cystic fibrosis, interstitial lung disease, tuberculosis, pulmonary neoplasm).
Indication for urgent thoracic surgery (e.g., imaging highly suggestive of giant bullae/blebs requiring immediate surgical intervention).
Pregnancy or breastfeeding.
Trial design
Design model
Parallel
Treatments tested in this trial
Conservative management (active observation)
Other interventionInitial in-hospital observation with a repeat chest X-ray ≥4 hours after the diagnostic film. If clinical and radiographic stability persists, discharge home with structured outpatient follow-up (≈1 week, then about every 2 weeks) until radiographic resolution (up to \~8 weeks if not resolved earlier). Rescue chest tube at any time for clinical deterioration or radiographic progression.
Chest tube drainage
Procedure/SurgeryChest tube insertion per usual care with hospital admission. Drain management and removal follow standard clinical criteria. After discharge, routine outpatient follow-up with chest X-rays documents resolution and tracks complications, additional procedures, and length of stay.
Treatment groups
436 Participants
are divided into 2 treatment groupsGroup A: Conservative management (active observation)Experimental treatment 1 intervention
Group B: Procedure: Chest tube drainageActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Complete lung re-expansion on chest X-ray
Proportion of participants with no pleural air on the 8-week chest X-ray (definition of complete radiographic resolution).
Time frame
8 weeks after randomization.Secondary outcomes
1
Treatment-related complications
Up to 24 weeks
Time frame
Procedure- or management-related adverse events (e.g., bleeding, infection, persistent air leak, need for reintervention or surgery), prospectively recorded.2
Recurrence of pneumothorax.
New ipsilateral pneumothorax occurring after documented complete resolution of the index event.
Time frame
Up to 2 years after resolution of the index episode.3
Health-Related Quality of Life Assessed by EQ-5D-5L
Changes in health-related quality of life measured using the EuroQol EQ-5D-5L questionnaire. Scores range from -0.281 to 1.000, with higher scores indicating better quality of life. Comparison between conservative management and chest tube drainage.
Time frame
Up to 24 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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