Comparing Efficacy of Chest Tube Drainage and Needle Aspiration in Pneumothorax Treatment

Randomized Controlled Trial on Comparison of Chest Tube Drainage and Needle Aspiration in Treatment of Spontaneous Pneumothorax

Spontaneous pneumothorax is a common condition which is defined as air presence inside of pleural space. Despite, several studies that have been carried on management patients suffering spontaneous pneumothorax, the first step approach on patients is still the topic of debate. Since chest tube drainage and needle aspiration are widely used first step techniques in spontaneous pneumothorax, current study compares the efficacy of abovementioned techniques, as well as long-term outcomes. In current multi-center single-blinded RCT, all patients admitted with spontaneous pneumothorax will be enrolled study and written consent form provided by patients, simultaneously. Patients randomly assigned to study groups including (A) chest tube drainage and (B) needle aspiration. Subsequently, all patients will undergo one-year follow-up and will be evaluated in terms of treatment success rate and pneumothorax recurrence. Hypothesis of present trial are as follows: a) repetitive needle aspiration may lead to higher treatment success rate in patients with primary spontaneous pneumothorax, in comparison to chest tube drainage, b) needle aspiration may result in reduction of hospital admission duration in patients with primary spontaneous pneumothorax compared to chest tube drainage, c) the rate of spontaneous pneumothorax recurrence during one-year follow up might be lower in patients who undergo needle aspiration instead of chest tube drainage.

Study Overview

• Status: Unknown
• Conditions: Pneumothorax, Spontaneous; Pneumothorax Spontaneous Primary; Pneumothorax, Recurrent; Pneumothorax Spontaneous Tension
• Intervention / Treatment: Procedure: Chest tube drainage; Procedure: Repetitive needle aspiration

Detailed Description

The chest tube drainage and needle aspiration are widely used first step techniques in spontaneous pneumothorax, thus present randomized controlled trial (RCT) aims to compare the efficacy of abovementioned techniques, as well as long-term outcomes. The study protocol has been confirmed by the ethics committee of AJA University. In current multi-center single-blinded RCT, all patients admitted with primary spontaneous pneumothorax will be enrolled study and written consent form provided by patients, simultaneously. With due attention to the success rate of 18% provided in a previous study comparing primary spontaneous pneumothorax treatment procedures and the study power of 80% and the confidence coefficient of 0.05, study population calculated to include 64 patient, which increased to 70 patients with taking 10% of falling risk into consideration. Using Randlist software, patients will be randomly assigned to study groups including (A) chest tube drainage and (B) needle aspiration. Subsequently, all patients will undergo one-year follow-up and will be evaluated in terms of treatment success rate and pneumothorax recurrence.

In chest tube drainage group, while the patient is positioned in the supine position and subsequent to local anesthesia administration via lidocaine 2%, F16 or F20 (based on patients physical status) sterile plastic tube will be implemented at the level 4th or 5th intercostal space through the midaxillary line. However, in needle aspiration group, patients will be positioned semi-supine. Subsequently, G16 intravenous angiocath will be inserted through the midclavicular line at the level 2nd or 3rd intercostal space. The catheter needle will be removed and catheter will be fixed using sterile sticks. A three-way valve will be connected to the external end of the catheter and a 50 ml syringe will be connected to the valve. The air suction will be performed using 50 ml syringe till end of the air suction or up to 3.5 liters of air suctioning.

Hypothesis of present trial are as follows: a) repetitive needle aspiration may lead to higher treatment success rate in patients with primary spontaneous pneumothorax, in comparison to chest tube drainage, b) needle aspiration may result in reduction of hospital admission duration in patients with primary spontaneous pneumothorax compared to chest tube drainage, c) the rate of spontaneous pneumothorax recurrence during one-year follow-up might be lower in patients who undergo needle aspiration instead of chest tube drainage.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • East Azerbaijan
    • Tabriz, East Azerbaijan, Iran, Islamic Republic of
      • Recruiting
      • Imam Reza Hospital
      • Contact: Seyed Ziaeddin Rasihashemi, Professor; Phone Number: +989144126652; Email: zia.hashemi@yahoo.com
      • Principal Investigator: Ali Ramouz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged more than 18 years old
• Symptomatic primary spontaneous pneumothorax or intervention-needed spontaneous pneumothorax (pneumothorax more than 20% in volume due to Light criteria)

Exclusion Criteria:

• Tension pneumothorax
• bilateral severe respiratory failure
• demand for mechanical ventilation
• bilateral pneumothorax

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chest tube drainage; This group will undergo chest tube drainage as an intervention for spontaneous pneumothorax treatment.	Procedure: Chest tube drainage; In this group, in the supine position and subsequent to prepping and draping and local anesthesia administration via lidocaine 2%, F16 or F20 (based on patients physical status) sterile plastic tube will be implemented at the level 4th or 5th intercostal space through the midaxillary line. Subsequently, the external end of the tube will be connected to water sealing bottle and water bubbles coming out will be considered as proper chest tube insertion.
Active Comparator: Needle aspiration; This group will undergo repetitive needle aspiration as an intervention for spontaneous pneumothorax treatment.	Procedure: Repetitive needle aspiration; In this group, prior to needle aspiration, patients will take the semi-supine position. Subsequent to local anesthesia via lidocaine 2%, as well as prepping and draping, G16 intravenous angiocath will be inserted through midclavicular line at the level 2nd or 3rd intercostal space. Air bubble inside the lidocaine syringe will be considered as needled entrance to pleural cavity, thus 5-10 cm of the angiocath will be import to inside of the cavity. The catheter needle will be removed and catheter will be fixed using sterile sticks. A three-way valve will be connected to external end of the catheter and a 50 ml syringe will be connected to the valve. The air suction will be performed using 50 ml syringe till end of the air suction or up to 3.5 liters of air suctioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumothorax recurrence during one-year	Will be defined as the rate of pneumothorax recurrence until postoperative one-year.	One year postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful treatment rate	Is defined as completely resolved pneumothorax during admission.	Postoperative day 1 and postoperative day 7
Length of hospital admission	will be calculated from the time of the operation to time of discharge.	Through hospital admission, an average of 10 days
Operation time	Will be calculated from the time of skin incision to completing the procedure including complete chest tube insertion in chest tube group or complete air suction or up to 3.5 liters of air suction in needle aspiration group.	During procedure
Procedure induced complications	Includes all complications occurred during or after procedure during hospital stay.	Postoperative day 1, Postoperative day 3, Postoperative day 7, Postoperative month 1,
Pneumothorax size	Will be calculated by Light's formula using chest radiography	Before procedure, 1 hour after procedure, 48 hours after procedure, one-week after procedure

Collaborators and Investigators

• Sponsor: Tabriz University of Medical Sciences
• Collaborators: AJA University of Medical Sciences

Publications and helpful links

General Publications

• MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986. No abstract available.
• Tschopp JM, Marquette CH. Spontaneous pneumothorax: stop chest tube as first-line therapy. Eur Respir J. 2017 Apr 12;49(4):1700306. doi: 10.1183/13993003.00306-2017. Print 2017 Apr. No abstract available.
• Hu X, Cowl CT, Baqir M, Ryu JH. Air travel and pneumothorax. Chest. 2014 Apr;145(4):688-694. doi: 10.1378/chest.13-2363.
• Cran IR, Rumball CA. Survey of spontaneous pneumothoraces in the Royal Air Force. Thorax. 1967 Sep;22(5):462-5. doi: 10.1136/thx.22.5.462.
• Harvey J, Prescott RJ. Simple aspiration versus intercostal tube drainage for spontaneous pneumothorax in patients with normal lungs. British Thoracic Society Research Committee. BMJ. 1994 Nov 19;309(6965):1338-9. doi: 10.1136/bmj.309.6965.1338. No abstract available.
• Dzeljilji A, Rokicki W, Rokicki M, Karus K. New aspects in the diagnosis and treatment of primary spontaneous pneumothorax. Kardiochir Torakochirurgia Pol. 2017 Mar;14(1):27-31. doi: 10.5114/kitp.2017.66926. Epub 2017 Mar 31.
• Thelle A, Gjerdevik M, SueChu M, Hagen OM, Bakke P. Randomised comparison of needle aspiration and chest tube drainage in spontaneous pneumothorax. Eur Respir J. 2017 Apr 12;49(4):1601296. doi: 10.1183/13993003.01296-2016. Print 2017 Apr.
• Tschopp JM, Bintcliffe O, Astoul P, Canalis E, Driesen P, Janssen J, Krasnik M, Maskell N, Van Schil P, Tonia T, Waller DA, Marquette CH, Cardillo G. ERS task force statement: diagnosis and treatment of primary spontaneous pneumothorax. Eur Respir J. 2015 Aug;46(2):321-35. doi: 10.1183/09031936.00219214. Epub 2015 Jun 25.
• Wakai A, O'Sullivan RG, McCabe G. Simple aspiration versus intercostal tube drainage for primary spontaneous pneumothorax in adults. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD004479. doi: 10.1002/14651858.CD004479.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2017
• Primary Completion (Anticipated): July 12, 2018
• Study Completion (Anticipated): October 12, 2018

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: IR.AJAUMS.REC.1396.24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No