Pneumothorax Drainage With Vacuum Bottle

Not Applicable

Completed

• Conditions: Iatrogenic Pneumothorax; Vacuum Bottle Assisted Needle Aspiration
• Interventions: Procedure: vacuum bottle

• Registration Number: NCT03724721
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.

Detailed Description

For aspiration or drainage of pneumothorax, a 16-gauge or 18-gauge over-the-needle non-tunneled catheter, a pigtail, or chest tube are frequently used to penetrate the pleural space. A 50-ml or 60-ml syringe may be connected to the over-the-needle catheter or a pigtail for simple aspiration, while underwater-sealed bottle or suction drainage connected to chest tube for drainage of pneumothorax. Vacuum bottle for removing pleural effusion are frequently reported in literature and common in daily practice. However, the use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.

Study Timeline

• Study Start: 2018-08-23
• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-10-28
• Study First Posted: 2018-10-30
• Primary Completion: 2020-02-11
• Study Completion: 2020-03-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pneumothorax drainage	vacuum bottle	Pneumothorax drainage with vacuum bottle plus intercostal catheter

Primary Outcome Measures

Name	Time	Method
Intrapleural pressure during vacuum bottle air drainage	Within 1 hour	The investigator will measure the intrapleural pressure during air drainage at 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes and until finished (the remaining with 5 minutes interval). It is proposed in previous studies that it is safe if the intrapleural pressure is less than 20 cmH2O during the procedure.

Secondary Outcome Measures

Name	Time	Method
Rate of reexpansion pulmonary edema	within 1day after the procedure	By calculating the rate of reexpansion pulmonary edema among vacuum bottle assisted drainage can investigator determine whether it is a safe procedure
The resolution rate of pneumothorax	1 week	Chest X ray will be taken after the procedure and compared with that taken before the procedure. By using Rhea method, the investigator can compare the percentage of remaining pneumothorax compared with that before the procedure.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan