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

NCT ID: NCT03293199

Last Updated: 2017-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-12

Study Completion Date

2018-10-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Chest tube drainage

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

Group Type ACTIVE_COMPARATOR

Chest tube drainage

Intervention Type 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.

Needle aspiration

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

Group Type ACTIVE_COMPARATOR

Repetitive needle aspiration

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AJA University of Medical Sciences

OTHER

Sponsor Role collaborator

Tabriz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ali Ramouz

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Imam Reza hospital

Tabriz, East Azerbaijan Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Ali Ramouz

Role: CONTACT

[email protected]
+989399418336

Facility Contacts

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Seyed Ziaeddin Rasihashemi, Professor

Role: primary

[email protected]
+989144126652

References

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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.

Reference Type BACKGROUND
PMID: 28404655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24687705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6050294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7755720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28515745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20696690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28404647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26113675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17253510 (View on PubMed)

Other Identifiers

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IR.AJAUMS.REC.1396.24

Identifier Type: -

Identifier Source: org_study_id