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Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods. (TOH-HTIC)

2018年12月20日 更新者:Hospices Civils de Lyon

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.

調査の概要

状態

完了

条件

研究の種類

介入

入学 (実際)

29

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Lyon、フランス、69004
        • Département d'anesthésie réanimation

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:診断
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Patients undergoing liver transplantation

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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Measure of the optic nerve sheath diameter during surgery.
時間枠:at incision
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.
at incision
Measure of the optic nerve sheath diameter during surgery.
時間枠:at anhepatic phase + 30 min
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.
at anhepatic phase + 30 min
Measure of the optic nerve sheath diameter during surgery.
時間枠:at declamping + 5 min
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.
at declamping + 5 min
Measure of the optic nerve sheath diameter during surgery.
時間枠:at declamping + 30 min
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.
at declamping + 30 min

二次結果の測定

結果測定
メジャーの説明
時間枠
Measurement of intracranial hypertension with transcranial Doppler during surgery.
時間枠:at incision

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.

at incision
Measurement of intracranial hypertension with transcranial Doppler during surgery.
時間枠:at anhepatic phase + 30 min

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.

at anhepatic phase + 30 min
Measurement of intracranial hypertension with transcranial Doppler during surgery.
時間枠:at declamping + 5 min

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.

at declamping + 5 min
Measurement of intracranial hypertension with transcranial Doppler during surgery.
時間枠:at declamping + 30 min

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.

at declamping + 30 min
Measurement of intracranial hypertension with transcranial Doppler
時間枠:at 1 day 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)
at 1 day after surgery.
Measure of the optic nerve sheath diameter after surgery.
時間枠:at 1 day 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)
at 1 day after surgery.
Measurement of intracranial hypertension with transcranial Doppler
時間枠:at 5 days 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)
at 5 days after surgery.
Measure of the optic nerve sheath diameter after surgery.
時間枠:at 5 days 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)
at 5 days after surgery.
The early appearance of neurological complications after surgery.
時間枠:During the 5 days following 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).
During the 5 days following surgery

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Mathieu GAZON, MD、Hospices Civils de Lyon

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2015年12月9日

一次修了 (実際)

2017年3月1日

研究の完了 (実際)

2017年3月1日

試験登録日

最初に提出

2016年2月11日

QC基準を満たした最初の提出物

2016年2月29日

最初の投稿 (見積もり)

2016年3月1日

学習記録の更新

投稿された最後の更新 (実際)

2018年12月21日

QC基準を満たした最後の更新が送信されました

2018年12月20日

最終確認日

2018年12月1日

詳しくは

本研究に関する用語

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Ultrasoundの臨床試験

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