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Reactor Thoracostomy (UNCUT)

Primary Purpose

Pneumothorax, Hemothorax

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Reactor Device
Tube thoracostomy
Sponsored by
Crozer-Keystone Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnant patients
  2. Prisoners
  3. Need for emergency thoracostomy
  4. Hemodynamic instability
  5. Respiratory distress

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Traditional

    Reactor Device

    Arm Description

    Outcomes

    Primary Outcome Measures

    Patient report of pain
    As measured on a 100mm VAS

    Secondary Outcome Measures

    Procedure time

    Full Information

    First Posted
    November 6, 2018
    Last Updated
    November 6, 2018
    Sponsor
    Crozer-Keystone Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03734471
    Brief Title
    Reactor Thoracostomy
    Acronym
    UNCUT
    Official Title
    Use of a Novel Chest Tube Insertion Device for Urgent Thoracostomy in an Emergency Department Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    July 1, 2019 (Anticipated)
    Study Completion Date
    November 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Crozer-Keystone Health System

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumothorax, Hemothorax

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Traditional
    Arm Type
    Active Comparator
    Arm Title
    Reactor Device
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Reactor Device
    Intervention Description
    The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.
    Intervention Type
    Procedure
    Intervention Name(s)
    Tube thoracostomy
    Intervention Description
    Traditional chest tube placement
    Primary Outcome Measure Information:
    Title
    Patient report of pain
    Description
    As measured on a 100mm VAS
    Time Frame
    During procedure
    Secondary Outcome Measure Information:
    Title
    Procedure time
    Time Frame
    During procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Reactor Thoracostomy

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