Skip to main content
OpenTrials
Completed

NCT Number: NCT03724721

Pneumothorax Drainage With Vacuum Bottle

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Iatrogenic Pneumothorax Pleural Diseases Pneumothorax Respiratory Tract Diseases Vacuum Bottle Assisted Needle Aspiration

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion criteria:

· Clinical diagnosis of pneumothorax

  • Exclusion criteria
  • Bleeding tendency
  • Tension pneumothorax
  • Shock

Treatment and study plan

vacuum bottle

Procedure

using vacuum bottle plus catheter for drainage of pneumothorax

Primary outcomes

  1. Intrapleural pressure during vacuum bottle air drainage

    Time frame: 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 outcomes

  1. Rate of reexpansion pulmonary edema

    Time frame: 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

  2. The resolution rate of pneumothorax

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2018
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.