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Operative Treatment of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma

Primary Purpose

Trauma, Flail Chest, Rib Fractures

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
NSAID
Opioids
Thoracic Epidural anaesthesia
Paracetamol
Surgical management
Sponsored by
Sahlgren´s University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring Prospective study, Surgical management, Unstable thoracic cage injuries, Trauma, Ventilator support

Eligibility Criteria

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

Inclusion Criteria:

  • Trauma with segmental rib fractures on at least 3 adjacent ribs ( anatomical flail chest )
  • Trauma with chest wall deformity

Exclusion Criteria:

  • Concurrent spinal cord injuries with paralysis
  • Severe head injury where normal level of consciousness is not resumed
  • Severe neurological and musculoskeletal diseases that influence the function of the thoracic wall and lung volumes

Sites / Locations

  • Departement of Surgery, Sahlgrenska University Hospital
  • Departement of Intensive Care, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surgical management

Conservative management

Arm Description

Operative fixation of unstable thoracic cage injuries and chest wall deformity. Thoracic Epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

Conservative management of unstable thoracic cage injuries and chest wall deformity. Thoracic epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

Outcomes

Primary Outcome Measures

Respiratory insufficiency
Need and length of ventilation therapy

Secondary Outcome Measures

Hospital stay
Time spent in an intensive care unit and total length of hospital stay

Full Information

First Posted
May 1, 2014
Last Updated
January 15, 2019
Sponsor
Sahlgren´s University Hospital
Collaborators
Sahlgrenska University Hospital, Sweden, Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02132416
Brief Title
Operative Treatment of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma
Official Title
Prospective Controlled Study of Surgical Management of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgren´s University Hospital
Collaborators
Sahlgrenska University Hospital, Sweden, Karolinska University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this prospective controlled study is to determine whether surgical management of unstable thoracic cage injuries and chest wall deformity in trauma reduces the need for and the time spent on ventilator compared to a group treated without operation.
Detailed Description
Patients meeting the inclusion criteria and giving their informed consent will be enrolled in this prospective controlled study. Included patients at Sahlgrenska University Hospital will undergo surgical stabilization of chest wall injuries and patients at Karolinska University Hospital will be managed conservatively. A total of 60 patients will be included in each group. 3D reconstructions of computed tomography images of the Thorax done at admission to the hospital will be used in order to evaluate injury according to Lung Injury Scale and Chest wall Injury Scale and for calculating radiological lung volumes and plan surgical procedure in the intervention group. Surgery will be performed as soon as possible after inclusion. MatrixRIB® (DePuy Synthes) Fixation system is used for stabilizing rib fractures with plates and angular locked screws. In cases where thoracotomy is done the patients will receive an anterior and posterior chest tube and wound drain with active suction. All patients, both in the intervention and in the control group will be offered thoracic epidural anaesthesia. Broad-spectrum intravenous antibiotic therapy is given as long as the patient has chest tubes. Thrombotic prophylaxis with LMWH is given until the patient is mobilized but for a minimum of 7 days. Patients will be followed-up 6 weeks, 6 months and 1 year post-operatively by surgeon and physiotherapist. A low-dosage computer tomography of the thorax will be done after 6 months in order to evaluate healing of the rib cage, possible non-union or dysfunction of osteosynthetic material and measure remaining lung volume. This examination will be compared to the initial computer tomography image done when the patient was admitted. At follow-ups complaints, possible late complications, usage of analgesia and return to work will be recorded. Evaluated instruments, EQ-5D-5L, VAS with Pain-O-Meter (POM) and Disability Rating Index (DRI) will be used to evaluate quality of life, pain and physical function. Range of motion in the thorax, thoracic spine and shoulders will be evaluated for every patient. Breathing movements will be measured by using a Respiratory movement measuring instrument (RMMI, ReMo Inc) and lung function tests will be performed in a standardized manner. In order to enrich the material, hospital data from patients fulfilling the inclusion criteria but not included, at the two study locations, during the inclusion period (June 2014 - June 2017) will be analyzed. An additional Ethical approval has been granted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Flail Chest, Rib Fractures, Surgery
Keywords
Prospective study, Surgical management, Unstable thoracic cage injuries, Trauma, Ventilator support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical management
Arm Type
Active Comparator
Arm Description
Operative fixation of unstable thoracic cage injuries and chest wall deformity. Thoracic Epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.
Arm Title
Conservative management
Arm Type
Active Comparator
Arm Description
Conservative management of unstable thoracic cage injuries and chest wall deformity. Thoracic epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.
Intervention Type
Drug
Intervention Name(s)
NSAID
Other Intervention Name(s)
Diclofenac, Naprosyn, Ibuprofen
Intervention Description
Will be used if tolerated.
Intervention Type
Drug
Intervention Name(s)
Opioids
Other Intervention Name(s)
Tramadol, Oxycodone, Morphine
Intervention Description
Initially intravenous administration and when tolerated oral slow-release pils will be used.
Intervention Type
Drug
Intervention Name(s)
Thoracic Epidural anaesthesia
Other Intervention Name(s)
Continous thoracic epidural anaesthesia will be offered.
Intervention Description
Given by specialists in anaesthesiology and intensive care.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Paracet, Alvedon, Panodil
Intervention Description
1g QID will be given to all patients unless allergies.
Intervention Type
Procedure
Intervention Name(s)
Surgical management
Other Intervention Name(s)
Matrix Rib Fixation System (DePuy Synthes).
Intervention Description
Fracture stabilization
Primary Outcome Measure Information:
Title
Respiratory insufficiency
Description
Need and length of ventilation therapy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hospital stay
Description
Time spent in an intensive care unit and total length of hospital stay
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Disability Rating Index
Description
Pain, function and mobility
Time Frame
1 year
Title
Quality of Life; EQ5D5L and VAS
Description
EQ-5D-5L instrument has a subscale of; 1 (no problems), 2 (slight problems), 3 (moderate problems), 4 (severe problems) and 5 (extreme problems). The Visual Analogue scale is a self-rating scale from 0% (the worst Health you can imagine) to 100% (the best Health you can imagine).
Time Frame
Time Frame

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Trauma with segmental rib fractures on at least 3 adjacent ribs ( anatomical flail chest ) Trauma with chest wall deformity Exclusion Criteria: Concurrent spinal cord injuries with paralysis Severe head injury where normal level of consciousness is not resumed Severe neurological and musculoskeletal diseases that influence the function of the thoracic wall and lung volumes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Granhed, MD PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eva-Corina Caragounis, MD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Surgery, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Departement of Intensive Care, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

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Operative Treatment of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma

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