Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient

Spinal Cord Injury Clinical Trial

— VASCIP  

Official title:

Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03114345
• Other study ID #: 9830
• Status: Terminated
• Phase: N/A
• Start date: November 22, 2017
• Est. completion date: November 22, 2019

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Paraplegic patients have defective wound healing for sore below the level of spinal lesion. Defect of vascularization of the healing zone certainly participate to this effect. Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g. the pressure between the patient body and the surface he/she is lying on) to assess the correlation between mechanical stress in term of pressure applied over time and tissue oxygenation which represent micro-vascular function. The aim of this clinical trial is to correlate the variations of pressure intensities and changes in micro-vascularization. The measure are recorded when paraplegic patient came into the hospital for pressure ulcer related surgery. The patient is laying on his/her mattress on top of a flexible pressure mapping device. The micro-vascularization parameters are measured at the area displaying the peak pressure a few minutes after the beginning of the pressure interface recording and one hour later at the same area. The data generated during this monocentric study will help to achieve a better understanding of the relation between pressure and micro-vascularization. In the mid term, it will provide a better and more patient adapted pressure ulcer prevention.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Educated consent signed,
• Older than 18,
• Paraplegia for at least 6 months,
• Surgery planned for pressure ulcer resection,

Exclusion Criteria:

• Dementia,
• Stade IV arteritis non-revascularisable,
• Patient with no health insurance,
• Pregnant women or breast-feeding, patient unable to give his or her educated consent, ward of the state (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9),
• Patient taking part in another study which could impact the local micro-vascularization.

Related Conditions & MeSH terms

• Bedsore
• Neovascularization, Pathologic
• Paraplegia
• Pressure Ulcer
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Other:
• Measurement of interface pressure
A capacitive pressure mapping device (XSensor) is set up on the patient air mattress bed. It records the interface pressure on the whole patient body with one frame every second during one hour. Then the file is saved and the pressure mapping device is removed from the patient hospital bedroom.
• Measurement of micro-vascularization related parameters
A medical device called O2C, measuring micro-vascularization related parameters (oxygen saturation, hemoglobin quantity and blood flow) is used. The probe (= an optic fibre) is set up lightly on the patient skin or on a transparent adhesive for 1 minute. The median value of the local micro-vascularization parameters are saved on the O2C interface. The location of the measurement is chosen using the pressure mapping device to locate peak pressure area. Then the O2C is removed from the patient hospital bedroom.

Locations

Country	Name	City	State
France	University Regional Hospital Lapeyronie	Montpellier	Languedoc-Roussillon

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Hill-Rom, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of the pressure intensity in one area	Pressure intensity is recorded using a mapping pressure device (XSensor), set up on the patient hospital bed. Hemoglobin quantity is measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive.	Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.
Primary	Measure of the hemoglobin quantity in the same area	Hemoglobin quantity is measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive.	Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.
Secondary	Measure of other micro-vascularization related parameters (such as the oxygen saturation and the blood flow) recorded at the same area.	All micro-vascularization related parameters are measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive.	Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.