Pneumothorax Drainage With Vacuum Bottle

Study Overview
=================
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.

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

Conditions
-----------------
Iatrogenic Pneumothorax, Vacuum Bottle Assisted Needle Aspiration

Intervention / Treatment
-----------------
* Procedure: vacuum bottle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: · Clinical diagnosis of pneumothorax Exclusion criteria Bleeding tendency Tension pneumothorax Shock

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pneumothorax drainage<br>Pneumothorax drainage with vacuum bottle plus intercostal catheter | Procedure: vacuum bottle<br>* using vacuum bottle plus catheter for drainage of pneumothorax<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumothorax/therapy, Drainage