search
Back to results

Pneumothorax Drainage With Vacuum Bottle

Primary Purpose

Iatrogenic Pneumothorax, Vacuum Bottle Assisted Needle Aspiration

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
vacuum bottle
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iatrogenic Pneumothorax focused on measuring Pneumothorax/therapy, Drainage

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  1. Inclusion criteria:

    · Clinical diagnosis of pneumothorax

  2. Exclusion criteria

    • Bleeding tendency
    • Tension pneumothorax
    • Shock

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pneumothorax drainage

Arm Description

Pneumothorax drainage with vacuum bottle plus intercostal catheter

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
October 16, 2018
Last Updated
January 11, 2021
Sponsor
National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03724721
Brief Title
Pneumothorax Drainage With Vacuum Bottle
Official Title
To Investigate the Safety and Efficacy of Vacuum Bottle Plus Catheter for Drainage of Pneumothorax
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
February 11, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iatrogenic Pneumothorax, Vacuum Bottle Assisted Needle Aspiration
Keywords
Pneumothorax/therapy, Drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pneumothorax drainage
Arm Type
Experimental
Arm Description
Pneumothorax drainage with vacuum bottle plus intercostal catheter
Intervention Type
Procedure
Intervention Name(s)
vacuum bottle
Intervention Description
using vacuum bottle plus catheter for drainage of pneumothorax
Primary Outcome Measure Information:
Title
Intrapleural pressure during vacuum bottle air drainage
Description
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.
Time Frame
Within 1 hour
Secondary Outcome Measure Information:
Title
Rate of reexpansion pulmonary edema
Description
By calculating the rate of reexpansion pulmonary edema among vacuum bottle assisted drainage can investigator determine whether it is a safe procedure
Time Frame
within 1day after the procedure
Title
The resolution rate of pneumothorax
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: · Clinical diagnosis of pneumothorax Exclusion criteria Bleeding tendency Tension pneumothorax Shock
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuo Yao-Wen, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chen Shih-Yu, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
35672758
Citation
Chen SY, Kuo YW, Ho CC, Wu HD, Wang HC. Safety and efficacy of vacuum bottle plus catheter for drainage of iatrogenic pneumothorax. BMC Pulm Med. 2022 Jun 7;22(1):221. doi: 10.1186/s12890-022-02009-8.
Results Reference
derived

Learn more about this trial

Pneumothorax Drainage With Vacuum Bottle

We'll reach out to this number within 24 hrs