Manual aspiration versus digital drainage system in spontaneous primary pneumothorax

Manual Aspiration Versus DIgital drainage system in spontaneous primary pneumothorax: open blinded two parallel group randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN46137912

Enrollment

104

Registered

2011-09-28

Start date

2011-09-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous primary pneumothorax Respiratory Other spontaneous pneumothorax

Interventions

Control arm: A plastic catheter (Pleurocaht 8Fr) is inserted into the second anterior intercostal space on the midclavicular line. The air is pulled out with manual syringe (50cc, until 3500cc or unti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with first episode of primary spontaneous pneumothorax

Exclusion criteria

Exclusion criteria: 1. Traumatic or iatrogenic pneumothorax 2. Secondary pneumothorax 3. Catamenial pneumothorax 4. Previous epidodes of oneumothorax 5. Bialteral pneumothorax 6. Tension pneumothorax 7. Immunosuppresion

Design outcomes

Primary

Measure	Time frame
Pneumothorax resolution in chest X ray performed six hours after the catheter insertion, accepted range 4-12h to ensure the patient's sleep	—

Secondary

Measure	Time frame
1. Risk of hospital admission 2. Relapse of pneumothorax 3. Resolution after 1 week 4. Percentage of patients that need surgery 5. Percentage of smoking cessation	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026