Conservative Management in Primary Spontaneous Pneumothorax: a Multicenter Randomized Non-inferiority Study

Summary

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.

Conditions

• Primary Spontaneous Pneumothorax (PSP)
• Conservative Management (Active Observation)

Interventions

OTHER

Conservative management (active observation)

Initial 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.

PROCEDURE

Chest tube drainage

Chest 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.

Sponsors & Collaborators

• Corporacion Parc Tauli

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2027-11-01

Completion

2028-11-01