Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512870
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-04-30
Brief Title:
Can Near-Infrared Spectroscopy NIRS or Intramuscular Glucose Levels Detect Impaired Leg Compartment Perfusion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Can Near Infrared Spectroscopy NIRS or Intramuscular Glucose Monitoring IMGM Detect Impaired Perfusion in the Anterior Compartment of the Leg in Patients With Tibial Fractures Proof of Concept Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIRS
Brief Summary:
Near infrared spectroscopy NIRS a technique that relies on differential absorption of infrared light to provide relative estimation of tissue oxygenation has been successfully used to monitor perfusion of various tissues including muscle tissue of the lower extremity however available research reports mixed success and this technology is not currently a standard of care for patients with leg fractures
The investigators propose use of NIRS technology in patients with diagnosis of tibial fracture and acute compartment syndrome to detect document impaired perfusion of the anterior compartment of the leg as compared to their non-broken leg The investigators also propose measurement of intramuscular glucose level in the affected leg and compare it to a fingerstick glucose to detect relative hypoglycemia in the affected muscular compartment If proven effective NIRS or IM glucose or both techniques could be used for clinical monitoring of patients with tibial fractures at risk for acute compartment syndrome
The investigators propose use of NIRS technology in patients with diagnosis of tibial fracture and acute compartment syndrome to detect document impaired perfusion of the anterior compartment of the leg as compared to their non-broken leg The investigators also propose measurement of intramuscular glucose level in the affected leg and compare it to a fingerstick glucose to detect relative hypoglycemia in the affected muscular compartment If proven effective NIRS or IM glucose or both techniques could be used for clinical monitoring of patients with tibial fractures at risk for acute compartment syndrome
Detailed Description:
Inclusion criteria
Patients age 18 - 75 years old
Diagnosis of tibial fracture or fracture-dislocation with diagnosis of acute compartment syndrome ANDOR diagnosis of concomitant vascular injury with documented loss of pulses in the leg below the knee
Unilateral injury ie only one leg is affected
Depth of anterior compartment of the leg 25 cm as measured by ultrasound Study size - 7-10 patients
Procedure of enrollment
When diagnosis of tibial fracture with vascular compromise or established ACS is made by the ED physician and confirmed by the Orthopedic surgeon study team will be notified immediately by the orthopedic service
Study team member will approach the study candidate explain the purpose of the study and obtain the informed consent
After obtaining the consent pre-scanning of the anterior compartment of the leg will be performed at bedside to measure the depth between the surface of the skin and the muscle
If depth of the anterior muscular compartment found to be 25 cm NIRS sensors will be applied to the skin of the broken leg at that location and to the corresponding location on the uninjured leg Sensors will be connected to the monitor and readings will be obtained until patient enters the OR
Sensor will be removed from the skin of the injured extremity but will stay in place on uninjured leg to describe tissue perfusion changed which occur during anesthesia
When incision is made by the surgeon upon entering the anterior muscular-fascial compartment blood sample will be obtained from the cut surface of the muscle for glucose concentration measurement At the same time fingerstick will be performed and capillary glucose will be measured Both glucose readings will be recorded
Before entering the anterior compartment intracompartmental pressure measurement will be performed by the surgeon using a sterile arterial line catheter attached to the transducer connected to the anesthesia monitor or with the Striker device - at surgeon discretion
At completion of the surgery sensor will be re-applied on the anterior compartment of the injured leg before dressing application
Monitoring of both extremities will continue for 72 hrs following surgery if condition of the operative extremity permits presence of the sensor
All available data stored in the monitor then will be downloaded and analyzed Please see more specific time points below
Data analysis
NIRS readings will be collected at the following timepoints
time 0 after sensors application - both legs
Time in the OR - surgery - for uninjured leg only - 1 hr after induction of general anesthesia
Time in the OR - post surgery after emergence from anesthesia - both legs
Every 6 hrs thereafter for the first 24 hrs
Every 12 hrs for subsequent 48 hrs Graphic analysis Superimposed graphs trajectories of all patients in each group with vascular injury and without vascular injury
Means will be calculated for the injured and uninjured leg for all time points as mentioned above
Graphs for means will be also created and analyzed Additionally the following data will be collected demographic data patients age gender fracture diagnosis time from admission to surgery type of surgery performed external temporary fixation internal fixation with intramedullary nail vs with plates
Data will be downloaded to the encrypted thumb-drive and transferred to a password-protected electronic file on HSC server Only HRRC-approved investigators will have access to the files
After completion of the study all electronic data will be destroyed Temporary data sheets will be used to facilitate data collection They will be stored in the locked cabinet in the Anesthesiology department offices away from patient areas
Upon enrollment patients will be given numbers from 1 to 10 After complete set of data is obtained each patient will be de-identified Should need arise to refer back to the electronic data patients will be only identified by their numbers from 1 to 10 and their respective sets of data
Patients age 18 - 75 years old
Diagnosis of tibial fracture or fracture-dislocation with diagnosis of acute compartment syndrome ANDOR diagnosis of concomitant vascular injury with documented loss of pulses in the leg below the knee
Unilateral injury ie only one leg is affected
Depth of anterior compartment of the leg 25 cm as measured by ultrasound Study size - 7-10 patients
Procedure of enrollment
When diagnosis of tibial fracture with vascular compromise or established ACS is made by the ED physician and confirmed by the Orthopedic surgeon study team will be notified immediately by the orthopedic service
Study team member will approach the study candidate explain the purpose of the study and obtain the informed consent
After obtaining the consent pre-scanning of the anterior compartment of the leg will be performed at bedside to measure the depth between the surface of the skin and the muscle
If depth of the anterior muscular compartment found to be 25 cm NIRS sensors will be applied to the skin of the broken leg at that location and to the corresponding location on the uninjured leg Sensors will be connected to the monitor and readings will be obtained until patient enters the OR
Sensor will be removed from the skin of the injured extremity but will stay in place on uninjured leg to describe tissue perfusion changed which occur during anesthesia
When incision is made by the surgeon upon entering the anterior muscular-fascial compartment blood sample will be obtained from the cut surface of the muscle for glucose concentration measurement At the same time fingerstick will be performed and capillary glucose will be measured Both glucose readings will be recorded
Before entering the anterior compartment intracompartmental pressure measurement will be performed by the surgeon using a sterile arterial line catheter attached to the transducer connected to the anesthesia monitor or with the Striker device - at surgeon discretion
At completion of the surgery sensor will be re-applied on the anterior compartment of the injured leg before dressing application
Monitoring of both extremities will continue for 72 hrs following surgery if condition of the operative extremity permits presence of the sensor
All available data stored in the monitor then will be downloaded and analyzed Please see more specific time points below
Data analysis
NIRS readings will be collected at the following timepoints
time 0 after sensors application - both legs
Time in the OR - surgery - for uninjured leg only - 1 hr after induction of general anesthesia
Time in the OR - post surgery after emergence from anesthesia - both legs
Every 6 hrs thereafter for the first 24 hrs
Every 12 hrs for subsequent 48 hrs Graphic analysis Superimposed graphs trajectories of all patients in each group with vascular injury and without vascular injury
Means will be calculated for the injured and uninjured leg for all time points as mentioned above
Graphs for means will be also created and analyzed Additionally the following data will be collected demographic data patients age gender fracture diagnosis time from admission to surgery type of surgery performed external temporary fixation internal fixation with intramedullary nail vs with plates
Data will be downloaded to the encrypted thumb-drive and transferred to a password-protected electronic file on HSC server Only HRRC-approved investigators will have access to the files
After completion of the study all electronic data will be destroyed Temporary data sheets will be used to facilitate data collection They will be stored in the locked cabinet in the Anesthesiology department offices away from patient areas
Upon enrollment patients will be given numbers from 1 to 10 After complete set of data is obtained each patient will be de-identified Should need arise to refer back to the electronic data patients will be only identified by their numbers from 1 to 10 and their respective sets of data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None