Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods. (TOH-HTIC)
Primary Purpose
Liver Transplantation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Transplantation focused on measuring intracranial hypertension, liver transplantation, transcranial Doppler, optic nerve sheath diameter
Eligibility Criteria
Inclusion Criteria:
- Patients ≥ 18 years
- Patients who underwent orthotopic liver transplantation
- Patients who have received clear information and not opposed to participate in the study
- Patients affiliated to a social security scheme or similar
- Patients not undergoing a measure of legal protection
Exclusion Criteria:
- Opposition to participation in the study
- Patients < 18 years
- Pregnant women or breastfeeding
- Deprived of individual liberty
- Non-affiliated to a social security scheme
- Known ophthalmic pathology: untreated cataracts, glaucoma
Sites / Locations
- Département d'anesthésie réanimation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients undergoing liver transplantation
Arm Description
Outcomes
Primary Outcome Measures
Measure of the optic nerve sheath diameter during surgery.
A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure > 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values> 5.7mm are deemed pathological.
Measure of the optic nerve sheath diameter during surgery.
A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure > 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values> 5.7mm are deemed pathological.
Measure of the optic nerve sheath diameter during surgery.
A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure > 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values> 5.7mm are deemed pathological.
Measure of the optic nerve sheath diameter during surgery.
A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure > 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values> 5.7mm are deemed pathological.
Secondary Outcome Measures
Measurement of intracranial hypertension with transcranial Doppler during surgery.
Diastolic velocity value of less than 20 cm s-1 and a pulsatility index greater than 1.4 will be considered pathological, indicating a high probability of intracranial hypertension.
The transcranial Doppler measurements are performed according to the existing protocols: use of a cardiac probe 2 Mhz, positioned temporal window, the circle of Willis color Doppler tracking then collecting the Doppler signal of the middle cerebral artery in Doppler pulsed with the insonation angle as small as possible to a depth between 40 and 60 mm. Measuring systolic, diastolic and mean velocity )Vs, Vd, Vm) and calculating the pulsatility Index (PI) bilaterally. PI values of> 1.4 and Vd <20 cm s-1 will be considered pathological.
Measurement of intracranial hypertension with transcranial Doppler during surgery.
Diastolic velocity value of less than 20 cm s-1 and a pulsatility index greater than 1.4 will be considered pathological, indicating a high probability of intracranial hypertension.
The transcranial Doppler measurements are performed according to the existing protocols: use of a cardiac probe 2 Mhz, positioned temporal window, the circle of Willis color Doppler tracking then collecting the Doppler signal of the middle cerebral artery in Doppler pulsed with the insonation angle as small as possible to a depth between 40 and 60 mm. Measuring systolic, diastolic and mean velocity )Vs, Vd, Vm) and calculating the pulsatility Index (PI) bilaterally. PI values of> 1.4 and Vd <20 cm s-1 will be considered pathological.
Measurement of intracranial hypertension with transcranial Doppler during surgery.
Diastolic velocity value of less than 20 cm s-1 and a pulsatility index greater than 1.4 will be considered pathological, indicating a high probability of intracranial hypertension.
The transcranial Doppler measurements are performed according to the existing protocols: use of a cardiac probe 2 Mhz, positioned temporal window, the circle of Willis color Doppler tracking then collecting the Doppler signal of the middle cerebral artery in Doppler pulsed with the insonation angle as small as possible to a depth between 40 and 60 mm. Measuring systolic, diastolic and mean velocity )Vs, Vd, Vm) and calculating the pulsatility Index (PI) bilaterally. PI values of> 1.4 and Vd <20 cm s-1 will be considered pathological.
Measurement of intracranial hypertension with transcranial Doppler during surgery.
Diastolic velocity value of less than 20 cm s-1 and a pulsatility index greater than 1.4 will be considered pathological, indicating a high probability of intracranial hypertension.
The transcranial Doppler measurements are performed according to the existing protocols: use of a cardiac probe 2 Mhz, positioned temporal window, the circle of Willis color Doppler tracking then collecting the Doppler signal of the middle cerebral artery in Doppler pulsed with the insonation angle as small as possible to a depth between 40 and 60 mm. Measuring systolic, diastolic and mean velocity )Vs, Vd, Vm) and calculating the pulsatility Index (PI) bilaterally. PI values of> 1.4 and Vd <20 cm s-1 will be considered pathological.
Measurement of intracranial hypertension with transcranial Doppler
we use the same methods and the same thresholds as those used during surgery (primary outcome measure, and measure1 of secondary outcome measure)
Measure of the optic nerve sheath diameter after surgery.
we use the same methods and the same thresholds as those used during surgery (primary outcome measure, and measure1 of secondary outcome measure)
Measurement of intracranial hypertension with transcranial Doppler
we use the same methods and the same thresholds as those used during surgery (primary outcome measure, and measure1 of secondary outcome measure)
Measure of the optic nerve sheath diameter after surgery.
we use the same methods and the same thresholds as those used during surgery (primary outcome measure, and measure1 of secondary outcome measure)
The early appearance of neurological complications after surgery.
A monitoring with simultaneous collection of clinical, biological and ultrasound parameters, will be done. Neurological complications after surgery will be defined by the presence of at least one of the following criteria: Glasgow score < 14 in a non-sedated patient, behavioral disorders, agitation (evaluation according to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score), epilepsy, imaging or MRI scan. Pathological evolved compared to the preoperative including hemorrhagic or thrombotic cardiovascular event. Various confounding factors will be considered (serum sodium, serum tacrolimus, serum magnesium, ammonia, sedatives).
Full Information
NCT ID
NCT02695823
First Posted
February 11, 2016
Last Updated
December 20, 2018
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02695823
Brief Title
Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods.
Acronym
TOH-HTIC
Official Title
Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 9, 2015 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acute or chronic liver failure (fulminant hepatitis or advanced cirrhosis) disrupts brain physiology. Beyond classical hepatic encephalopathy, intracranial hypertension may occur.During liver transplantation (LT) surgery, many factors can lead to cerebral assault. In addition, intracranial hypertension measured with invasive methods has been described in certain phases of LT, especially at the time of reperfusion.
The invasive monitoring of the intracranial pressure is not used in these patients, due to a high risk of infection and bleeding. The non-invasive monitoring of intracranial pressure has been widely developed in recent years : transcranial doppler and recently ultrasound of the optic nerve sheath (ONSD) allow an effective detection of intracranial hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation
Keywords
intracranial hypertension, liver transplantation, transcranial Doppler, optic nerve sheath diameter
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing liver transplantation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound measurements of the optic nerve sheath diameter and intracranial Doppler, at 4 time points during surgery (incision, anhepatic phase + 30 min, declamping + 5 min, declamping + 30 min), and at day 1 and day 5 after surgery, to detect presence of intracranial hypertension.
Search of any neurological complication during the 5 postoperative days.
Primary Outcome Measure Information:
Title
Measure of the optic nerve sheath diameter during surgery.
Description
A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure > 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values> 5.7mm are deemed pathological.
Time Frame
at incision
Title
Measure of the optic nerve sheath diameter during surgery.
Description
A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure > 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values> 5.7mm are deemed pathological.
Time Frame
at anhepatic phase + 30 min
Title
Measure of the optic nerve sheath diameter during surgery.
Description
A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure > 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values> 5.7mm are deemed pathological.
Time Frame
at declamping + 5 min
Title
Measure of the optic nerve sheath diameter during surgery.
Description
A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure > 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values> 5.7mm are deemed pathological.
Time Frame
at declamping + 30 min
Secondary Outcome Measure Information:
Title
Measurement of intracranial hypertension with transcranial Doppler during surgery.
Description
Diastolic velocity value of less than 20 cm s-1 and a pulsatility index greater than 1.4 will be considered pathological, indicating a high probability of intracranial hypertension.
The transcranial Doppler measurements are performed according to the existing protocols: use of a cardiac probe 2 Mhz, positioned temporal window, the circle of Willis color Doppler tracking then collecting the Doppler signal of the middle cerebral artery in Doppler pulsed with the insonation angle as small as possible to a depth between 40 and 60 mm. Measuring systolic, diastolic and mean velocity )Vs, Vd, Vm) and calculating the pulsatility Index (PI) bilaterally. PI values of> 1.4 and Vd <20 cm s-1 will be considered pathological.
Time Frame
at incision
Title
Measurement of intracranial hypertension with transcranial Doppler during surgery.
Description
Diastolic velocity value of less than 20 cm s-1 and a pulsatility index greater than 1.4 will be considered pathological, indicating a high probability of intracranial hypertension.
The transcranial Doppler measurements are performed according to the existing protocols: use of a cardiac probe 2 Mhz, positioned temporal window, the circle of Willis color Doppler tracking then collecting the Doppler signal of the middle cerebral artery in Doppler pulsed with the insonation angle as small as possible to a depth between 40 and 60 mm. Measuring systolic, diastolic and mean velocity )Vs, Vd, Vm) and calculating the pulsatility Index (PI) bilaterally. PI values of> 1.4 and Vd <20 cm s-1 will be considered pathological.
Time Frame
at anhepatic phase + 30 min
Title
Measurement of intracranial hypertension with transcranial Doppler during surgery.
Description
Diastolic velocity value of less than 20 cm s-1 and a pulsatility index greater than 1.4 will be considered pathological, indicating a high probability of intracranial hypertension.
The transcranial Doppler measurements are performed according to the existing protocols: use of a cardiac probe 2 Mhz, positioned temporal window, the circle of Willis color Doppler tracking then collecting the Doppler signal of the middle cerebral artery in Doppler pulsed with the insonation angle as small as possible to a depth between 40 and 60 mm. Measuring systolic, diastolic and mean velocity )Vs, Vd, Vm) and calculating the pulsatility Index (PI) bilaterally. PI values of> 1.4 and Vd <20 cm s-1 will be considered pathological.
Time Frame
at declamping + 5 min
Title
Measurement of intracranial hypertension with transcranial Doppler during surgery.
Description
Diastolic velocity value of less than 20 cm s-1 and a pulsatility index greater than 1.4 will be considered pathological, indicating a high probability of intracranial hypertension.
The transcranial Doppler measurements are performed according to the existing protocols: use of a cardiac probe 2 Mhz, positioned temporal window, the circle of Willis color Doppler tracking then collecting the Doppler signal of the middle cerebral artery in Doppler pulsed with the insonation angle as small as possible to a depth between 40 and 60 mm. Measuring systolic, diastolic and mean velocity )Vs, Vd, Vm) and calculating the pulsatility Index (PI) bilaterally. PI values of> 1.4 and Vd <20 cm s-1 will be considered pathological.
Time Frame
at declamping + 30 min
Title
Measurement of intracranial hypertension with transcranial Doppler
Description
we use the same methods and the same thresholds as those used during surgery (primary outcome measure, and measure1 of secondary outcome measure)
Time Frame
at 1 day after surgery.
Title
Measure of the optic nerve sheath diameter after surgery.
Description
we use the same methods and the same thresholds as those used during surgery (primary outcome measure, and measure1 of secondary outcome measure)
Time Frame
at 1 day after surgery.
Title
Measurement of intracranial hypertension with transcranial Doppler
Description
we use the same methods and the same thresholds as those used during surgery (primary outcome measure, and measure1 of secondary outcome measure)
Time Frame
at 5 days after surgery.
Title
Measure of the optic nerve sheath diameter after surgery.
Description
we use the same methods and the same thresholds as those used during surgery (primary outcome measure, and measure1 of secondary outcome measure)
Time Frame
at 5 days after surgery.
Title
The early appearance of neurological complications after surgery.
Description
A monitoring with simultaneous collection of clinical, biological and ultrasound parameters, will be done. Neurological complications after surgery will be defined by the presence of at least one of the following criteria: Glasgow score < 14 in a non-sedated patient, behavioral disorders, agitation (evaluation according to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score), epilepsy, imaging or MRI scan. Pathological evolved compared to the preoperative including hemorrhagic or thrombotic cardiovascular event. Various confounding factors will be considered (serum sodium, serum tacrolimus, serum magnesium, ammonia, sedatives).
Time Frame
During the 5 days following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients ≥ 18 years
Patients who underwent orthotopic liver transplantation
Patients who have received clear information and not opposed to participate in the study
Patients affiliated to a social security scheme or similar
Patients not undergoing a measure of legal protection
Exclusion Criteria:
Opposition to participation in the study
Patients < 18 years
Pregnant women or breastfeeding
Deprived of individual liberty
Non-affiliated to a social security scheme
Known ophthalmic pathology: untreated cataracts, glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu GAZON, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département d'anesthésie réanimation
City
Lyon
ZIP/Postal Code
69004
Country
France
12. IPD Sharing Statement
Learn more about this trial
Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods.
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