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

NCT03293199 | Unknown

• 1 other identifier: IR.AJAUMS.REC.1396.24
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumothorax Spontaneous Primary; Pneumothorax, Recurrent; Pneumothorax Spontaneous Tension; Pneumothorax, Spontaneous

Outcome Measures

Primary Outcomes (1)

• Pneumothorax recurrence during one-year

  Will be defined as the rate of pneumothorax recurrence until postoperative one-year.

  One year postoperative

Secondary Outcomes (5)

• Successful treatment rate

  Postoperative day 1 and postoperative day 7

• Length of hospital admission

  Through hospital admission, an average of 10 days

• Operation time

  During procedure

• Procedure induced complications

  Postoperative day 1, Postoperative day 3, Postoperative day 7, Postoperative month 1,

• Pneumothorax size

  Before procedure, 1 hour after procedure, 48 hours after procedure, one-week after procedure

Study Arms (2)

Chest tube drainage

ACTIVE COMPARATOR

This group will undergo chest tube drainage as an intervention for spontaneous pneumothorax treatment.

Procedure: Chest tube drainage

Needle aspiration

ACTIVE COMPARATOR

This group will undergo repetitive needle aspiration as an intervention for spontaneous pneumothorax treatment.

Procedure: Repetitive needle aspiration

Interventions

Chest tube drainage PROCEDURE

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.

Chest tube drainage

Repetitive needle aspiration PROCEDURE

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.

Needle aspiration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Tabriz University of Medical Sciences: lead
• AJA University of Medical Sciences: collaborator

Study Sites (1)

Imam Reza hospital

Tabriz, East Azerbaijan Province, Iran

RECRUITING

Related Publications (9)

• 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.

  PMID: 28404655 BACKGROUND

• 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.

  PMID: 24687705 BACKGROUND

• 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.

  PMID: 6050294 BACKGROUND

• 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.

  PMID: 7755720 BACKGROUND

• 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.

  PMID: 28515745 BACKGROUND

• 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.

  PMID: 20696690 BACKGROUND

• 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.

  PMID: 28404647 BACKGROUND

• 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.

  PMID: 26113675 BACKGROUND

• 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.

  PMID: 17253510 BACKGROUND

MeSH Terms

Conditions

Pneumothorax; Recurrence

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ali Ramouz

CONTACT

+989399418336; ramouza@tbzmed.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Since patients are alert and conscious, therefore we are unable to blind the participants. However, care provider will not take part in the data acquisition and outcome analysis. The investigator and outcome assessor will be blinded to patients allocated group and treatment type provided in each patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Patients will be randomly and equally assigned to study groups, as follows: group (a) will undergo chest tube drainage implementation and group (b) will undergo repetitive needle aspiration till pnuemothorax resolution.

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 26, 2017
• Study Start: August 12, 2017
• Primary Completion: July 12, 2018
• Study Completion: October 12, 2018
• Last Updated: September 26, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)