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

Pneumothorax, Spontaneous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03293199
• Other study ID #: IR.AJAUMS.REC.1396.24
• Status: Recruiting
• Phase: N/A
• First received: September 18, 2017
• Last updated: September 21, 2017
• Start date: August 12, 2017
• Est. completion date: October 12, 2018

Study information

• Verified date: September 2017
• Source: Tabriz University of Medical Sciences
• Contact: Ali Ramouz
• Phone: +989399418336
• Email: ramouza[@]tbzmed.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumothorax
• Pneumothorax Spontaneous Primary
• Pneumothorax Spontaneous Tension
• Pneumothorax, Recurrent
• Pneumothorax, Spontaneous

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Reza hospital	Tabriz	East Azerbaijan

Sponsors (2)

Lead Sponsor	Collaborator
Tabriz University of Medical Sciences	AJA University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (9)

Cran IR, Rumball CA. Survey of spontaneous pneumothoraces in the Royal Air Force. Thorax. 1967 Sep;22(5):462-5. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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). pii: 1601296. doi: 10.1183/13993003.01296-2016. Print 2017 Apr. — View Citation

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. Review. — View Citation

Tschopp JM, Marquette CH. Spontaneous pneumothorax: stop chest tube as first-line therapy. Eur Respir J. 2017 Apr 12;49(4). pii: 1700306. doi: 10.1183/13993003.00306-2017. Print 2017 Apr. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumothorax recurrence during one-year	Will be defined as the rate of pneumothorax recurrence until postoperative one-year.	One year postoperative
Secondary	Successful treatment rate	Is defined as completely resolved pneumothorax during admission.	Postoperative day 1 and postoperative day 7
Secondary	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
Secondary	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
Secondary	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,
Secondary	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