Emergency Small vs Large Tube Thoracostomy in Chest Trauma Patients.

NCT04863989 | Unknown

• 1 other identifier: small sized thoracostomy
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare between small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube for the fear of obstruction (in hemomothorax) or ineffective drainage (in hemothorax, pneumothorax or hemo-pneumothorax) ,pain score or repositioning and need for thoracotomy.

Conditions

Traumatic Pneumothorax and Hemothorax

Outcome Measures

Primary Outcomes (1)

• To compare the number of patients who will have emergent small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube.

  To compare the number of patients who will have emergent small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube.

  baseline

Secondary Outcomes (2)

• Number of trauma patients who will have emergent small vs large thoracostomy tube regarding pain score

  baseline

• Number of trauma patients who will have emergent small vs large thoracostomy tube regarding duration of tube insertion.

  baseline

Study Arms (2)

Small sized chest tube

EXPERIMENTAL

Insertion of small sized chest tube in patients with traumatic hemothorax, pneumothorax or hemopneumothorax.

Procedure: tube thoracostomy

Large sized chest tube

ACTIVE COMPARATOR

insertion of large sized chest tube in patients with traumatic hemothorax, pneumothorax or hemopneumothorax.

Procedure: tube thoracostomy

Interventions

tube thoracostomy PROCEDURE

insertion of intercostal tube for drainage of traumatic hemothorax or pneumothorax

Large sized chest tube; Small sized chest tube

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all chest trauma patients with significant hemothorax, pneumothorax or combined hemo-pneumothorax

You may not qualify if:

• any chest trauma patients undergoing thoracotomy or thoracic surgery for any other reason for example : diaphragmatic tear,flail chest or sternal fracture

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• Cooke DT, David EA. Large-bore and small-bore chest tubes: types, function, and placement. Thorac Surg Clin. 2013 Feb;23(1):17-24, v. doi: 10.1016/j.thorsurg.2012.10.006.

  PMID: 23206714 BACKGROUND

• Meyer JA. Gotthard Bulau and closed water-seal drainage for empyema, 1875-1891. Ann Thorac Surg. 1989 Oct;48(4):597-9. doi: 10.1016/s0003-4975(10)66876-2.

  PMID: 2679468 BACKGROUND

• Van Schil PE. Thoracic drainage and the contribution of Gotthard Bulau. Ann Thorac Surg. 1997 Dec;64(6):1876. No abstract available.

  PMID: 9436605 BACKGROUND

• Monaghan SF, Swan KG. Tube thoracostomy: the struggle to the "standard of care". Ann Thorac Surg. 2008 Dec;86(6):2019-22. doi: 10.1016/j.athoracsur.2008.08.006.

  PMID: 19022041 BACKGROUND

• HOWE BE Jr. Evaluation of chest suction with an artificial thorax. Surg Forum. 1951:1-7. No abstract available.

  PMID: 14931188 BACKGROUND

• Miller KS, Sahn SA. Chest tubes. Indications, technique, management and complications. Chest. 1987 Feb;91(2):258-64. doi: 10.1378/chest.91.2.258. No abstract available.

  PMID: 3542404 BACKGROUND

• Filosso PL, Sandri A, Guerrera F, Ferraris A, Marchisio F, Bora G, Costardi L, Solidoro P, Ruffini E, Oliaro A. When size matters: changing opinion in the management of pleural space-the rise of small-bore pleural catheters. J Thorac Dis. 2016 Jul;8(7):E503-10. doi: 10.21037/jtd.2016.06.25.

  PMID: 27499983 BACKGROUND

• Tanizaki S, Maeda S, Sera M, Nagai H, Hayashi M, Azuma H, Kano KI, Watanabe H, Ishida H. Small tube thoracostomy (20-22 Fr) in emergent management of chest trauma. Injury. 2017 Sep;48(9):1884-1887. doi: 10.1016/j.injury.2017.06.021. Epub 2017 Jun 23.

  PMID: 28673640 BACKGROUND

• Rivera L, O'Reilly EB, Sise MJ, Norton VC, Sise CB, Sack DI, Swanson SM, Iman RB, Paci GM, Antevil JL. Small catheter tube thoracostomy: effective in managing chest trauma in stable patients. J Trauma. 2009 Feb;66(2):393-9. doi: 10.1097/TA.0b013e318173f81e.

  PMID: 19204512 BACKGROUND

• Towards evidence-based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 4: does size matter? Chest drains in haemothorax following trauma. Emerg Med J. 2013 Nov;30(11):965-7. doi: 10.1136/emermed-2013-203139.4.

  PMID: 24142946 BACKGROUND

• Inaba K, Lustenberger T, Recinos G, Georgiou C, Velmahos GC, Brown C, Salim A, Demetriades D, Rhee P. Does size matter? A prospective analysis of 28-32 versus 36-40 French chest tube size in trauma. J Trauma Acute Care Surg. 2012 Feb;72(2):422-7. doi: 10.1097/TA.0b013e3182452444.

  PMID: 22327984 BACKGROUND

• ATLS Subcommittee; American College of Surgeons' Committee on Trauma; International ATLS working group. Advanced trauma life support (ATLS(R)): the ninth edition. J Trauma Acute Care Surg. 2013 May;74(5):1363-6. doi: 10.1097/TA.0b013e31828b82f5. No abstract available.

  PMID: 23609291 BACKGROUND

MeSH Terms

Conditions

Hemothorax

Condition Hierarchy (Ancestors)

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

Central Study Contacts

amr mohamed mamdouh, resident

CONTACT

+201000566770; amrmamdouh_95@yahoo.com

hussein elkhayat, assistant professor

CONTACT

+201005549653; Elkhayat@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: April 28, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04