Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting

NCT04197505 | Withdrawn DMC

• 1 other identifier: 19-01424
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall objective of this study is to (1) determine whether thermal imaging can be used during an acute trauma patient's secondary or tertiary survey to identify injury sites with an underlying fracture, and to (2) investigate whether thermal imaging can predict those patients whose fractures will result in a non-union.

Conditions

Acute Fracture

Outcome Measures

Primary Outcomes (1)

• Comparison of thermal imaging of extremity with and without fracture

  The FLIR E95 thermal imaging camera will be used to obtain a temperature evaluation of the injury site. The extremity with the underlying fracture will have a higher temperature reading when compared to the contralateral extremity without a fracture. Thermal imaging was selected for the proposed work due to its feasibility and potential to be a useful tool in the acute trauma setting. A thermal imaging camera detects infrared radiation and converts it to visible light. The FLIR E95 utilizes a class two laser with an output power below 1mW and this laser is considered safe without a skin or materials burn hazard unless a person deliberately stares into the beam

  through study completion, an average of 18 months

Secondary Outcomes (1)

• Change in thermal imaging predicting non-union

  through study completion, an average of 18 months

Study Arms (1)

Acute fracture specific

EXPERIMENTAL

The FLIR E95 camera will be used for the study. The injured extremity will be scanned with the thermal camera and a second scan will be performed on the non-injured extremity to provide an internal control for any differences in room temperature and humidity. Prior to scanning, both the injured and non-injured extremity will remain uncovered for 10 minutes, about the length of an average office visit, and the areas to be scanned will remain free from contact by the patient or interviewer during this time period. The camera will be held 2 feet away from the extremity at a 90º angle to limit reading contamination from objects other than the patient.

Behavioral: FLIR E95 camera

Interventions

FLIR E95 camera BEHAVIORAL

Video will be recorded during the thermal reading for later computer analysis. The following variables will be analyzed: (1) the difference between the mean temperature between the injured and healthy extremities, (2) the difference between the maximum temperatures of both the injured and healthy extremities (ΔTmax), and (3) the difference between the area covered by each isotherm in both the injured and uninjured extremities (Δpix). FLIR software tools and MATLAB software will be used for the analysis.

Acute fracture specific

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 to 95
• Have fracture injury

You may not qualify if:

• Subjects suffering from a hypothermia- or hyperthermia - related illness or other environmental exposure-type illness
• Those with a concomitant fracture
• Subjects with no specific medical history or surgical history
• Subjects who cannot provide informed consent

Sponsors & Collaborators

• NYU Langone Health: lead

Study Officials

• Philipp Leucht

  NYU Langone

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: January 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to john.dankert@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.