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Reactor Thoracostomy (UNCUT)

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ClinicalTrials.gov Identifier: NCT03769727
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
Crozer-Keystone Health System
Sharp Medical Products, LLC
Information provided by (Responsible Party):
Kara B. Goddard, PharmD, BCPS, University of Missouri-Columbia

Brief Summary:

Tube thoracostomy is commonly performed in the emergency department for patients suffering from traumatic hemo- or pneumo-thorax. The procedure involves the use of a scalpel incision at the skin followed by blunt dissection through tissue, penetration into the thoracic cavity, dilation of a tract for tube placement, exploration of the thoracic cavity with a gloved finger, and finally insertion of a sterile tube into the intrathoracic space. The procedure is considered extremely painful despite the routine provision of systemic analgesics and local anesthetics.

Cadaver and animal studies have demonstrated the use of the Reactor chest tube device, a squeeze-activated thoracostomy trochar with placement of a clear sheath for chest tube insertion, to decrease procedure time, incision size, and blood loss. Case series and observational reports suggest lower rates of procedural complication and failure as well as increased patient satisfaction due to pain reduction.


Condition or disease Intervention/treatment Phase
Pneumothorax Hemothorax Device: Reactor Device Procedure: Tube Thoracostomy Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of a Novel Chest Tube Insertion Device for Urgent Thoracostomy in an Emergency Department Setting
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Arm Intervention/treatment
Active Comparator: Traditional
Procedure: Tube thoracostomy Traditional chest tube placement
Procedure: Tube Thoracostomy
Traditional chest tube placement

Experimental: Reactor Device
Device: Reactor Device The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.
Device: Reactor Device
The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.




Primary Outcome Measures :
  1. Patient report of pain [ Time Frame: During procedure ]
    As measured on a 100mm Visual Analog Scale (VAS), with a patient reported score of 0 representing no pain and 100 representing the worst pain possible. The patient will draw a line crossing the 100mm VAS at one location, with each millimeter representing a whole number (ex. 25mm = score of 25). Each marking will be measured to achieve the pain score on the VAS.


Secondary Outcome Measures :
  1. Procedure time [ Time Frame: During procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects age ≥ 18 years old
  • Attending physician determination of need for urgent tube thoracostomy for treatment of traumatic pneumothorax, hemothorax, or hemopneumothorax.
  • Hemodynamically stable

Exclusion Criteria:

  • Pregnant patients
  • Prisoners
  • Need for emergency thoracostomy
  • Hemodynamic instability
  • Respiratory distress

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769727


Contacts
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Contact: Kara B. Goddard, PharmD, BCPS 5738841605 goddardk@health.missouri.edu
Contact: Matthew T. Robinson, MD, FACEP, FAAEM 5738844400 robinsonmt@health.missouri.edu

Locations
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United States, Missouri
University of Missouri Health Care Recruiting
Columbia, Missouri, United States, 65212
Contact: Kara B. Goddard, PharmD, BCPS         
Contact: Matthew T. Robinson, MD, FACEP         
United States, Pennsylvania
Crozer-Keystone Health System Recruiting
Upland, Pennsylvania, United States, 19013
Contact: Richard Pescatore, DO, FAAEM         
Sponsors and Collaborators
University of Missouri-Columbia
Crozer-Keystone Health System
Sharp Medical Products, LLC
Investigators
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Principal Investigator: Richard Pescatore, DO, FAAEM Crozer-Keystone Health System

Additional Information:
Publications:

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Responsible Party: Kara B. Goddard, PharmD, BCPS, Clinical Pharmacy Specialist, Emergency Medicine, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03769727     History of Changes
Other Study ID Numbers: 2013215 MU
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Pneumothorax
Hemothorax
Pleural Diseases
Respiratory Tract Diseases
Hemorrhage
Pathologic Processes