Pneumothorax Drainage With Vacuum Bottle

Iatrogenic Pneumothorax Clinical Trial

Official title:

To Investigate the Safety and Efficacy of Vacuum Bottle Plus Catheter for Drainage of Pneumothorax

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724721
• Other study ID #: 201805105DINA
• Status: Completed
• Phase: N/A
• Start date: August 23, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 1, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

1. Inclusion criteria:

· Clinical diagnosis of pneumothorax

2. Exclusion criteria

• Bleeding tendency
• Tension pneumothorax
• Shock

Related Conditions & MeSH terms

• Iatrogenic Pneumothorax
• Pneumothorax
• Vacuum Bottle Assisted Needle Aspiration

Intervention

Procedure:
• vacuum bottle
using vacuum bottle plus catheter for drainage of pneumothorax

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrapleural pressure during vacuum bottle air drainage	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.	Within 1 hour
Secondary	Rate of reexpansion pulmonary edema	By calculating the rate of reexpansion pulmonary edema among vacuum bottle assisted drainage can investigator determine whether it is a safe procedure	within 1day after the procedure
Secondary	The resolution rate of pneumothorax	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.	1 week