Pneumothorax Drainage With Vacuum Bottle

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03724721
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arm: 1
• Actual Duration (Months): 18.3
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iatrogenic Pneumothorax; Vacuum Bottle Assisted Needle Aspiration	Procedure: vacuum bottle	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: To Investigate the Safety and Efficacy of Vacuum Bottle Plus Catheter for Drainage of Pneumothorax
• Actual Study Start Date: Aug 23, 2018
• Actual Primary Completion Date: Feb 11, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pneumothorax drainage Pneumothorax drainage with vacuum bottle plus intercostal catheter	Procedure: vacuum bottle; using vacuum bottle plus catheter for drainage of pneumothorax

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

1. Inclusion criteria:

· Clinical diagnosis of pneumothorax

1. Exclusion criteria

• Bleeding tendency

• Tension pneumothorax

• Shock

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Kuo Yao-Wen, MD, National Taiwan University Hospital
• Principal Investigator: Chen Shih-Yu, MD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT03724721
• Other Study ID Numbers: 201805105DINA
• First Posted: Oct 30, 2018
• Last Update Posted: Jan 12, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Taiwan University Hospital: Pneumothorax/therapy; Drainage
• Additional relevant MeSH terms: Pneumothorax

Study Results

No Results Posted as of Jan 12, 2021