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

NCT07331805 | Not Yet Recruiting DMC

• 1 other identifier: CONNEP_ 2025/3006
• Study Type: interventional
• Target: 436
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Primary Spontaneous Pneumothorax (PSP); Conservative management; Active observation / No initial intervention; Chest tube drainage (standard care); Complete lung re-expansion at 8 weeks; Chest X-ray; Collins method (size estimation); Clinical stability (stable PSP); Recurrence (up to 2 years); Quality of life and cost-effectiveness

Outcome Measures

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).

  8 weeks after randomization.

Secondary Outcomes (3)

• Treatment-related complications

  Procedure- or management-related adverse events (e.g., bleeding, infection, persistent air leak, need for reintervention or surgery), prospectively recorded.

• Recurrence of pneumothorax.

  Up to 2 years after resolution of the index episode.

• Health-Related Quality of Life Assessed by EQ-5D-5L

  Up to 24 weeks

Study Arms (2)

Conservative management (active observation)

EXPERIMENTAL

After randomization, participants remain under observation with a repeat chest X-ray ≥4 hours after the diagnostic film. If clinical and radiographic stability persists, they are discharged with structured outpatient follow-up: approximately 1-week review with a pre-visit X-ray, then every \~2 weeks until radiographic resolution (up to about 8 weeks of conservative management if not resolved earlier). Rescue chest tube is performed at any time if clinical deterioration or radiographic progression occurs.

Other: Conservative management (active observation)

Procedure: Chest tube drainage

ACTIVE COMPARATOR

After randomization, participants undergo chest tube insertion per usual care with hospital admission. Drain management and removal follow standard clinical criteria. After discharge, participants attend routine outpatient follow-up with chest X-rays to document resolution and to record complications, additional procedures, and length of stay.

Procedure: Chest tube drainage

Interventions

Conservative management (active observation) OTHER

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.

Conservative management (active observation)

Chest tube drainage PROCEDURE

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.

Procedure: Chest tube drainage

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Consent: Has read and understood the participant information sheet and signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

MeSH Terms

Conditions

Pneumothorax; Recurrence

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Carlos Molero-Cano, Surgeon

CONTACT

+34 697664410; cmolerocano@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residente de Cirugía General y del Aparato Digestivo

Model Details: Randomized, parallel-assignment, multicenter, open-label, non-inferiority clinical trial with two arms (conservative management vs. chest tube), primary purpose: treatment.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share