- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05346471
Infra- and Supratentorial Neuromonitoring (DUAL-ICP)
Infra- and Supratentorial Neuromonitoring in Patients With Posterior Fossa Lesions: DUAL-ICP Trial
Invasive neuromonitoring of intracranial pressure (ICP) is an important element of neurosurgical critical care that is used primarily as an indicator of adequate cerebral perfusion in patients, when clinical observation is not an option. Due to the constraint in size and the critical structures within the posterior fossa, detection of intracranial pressure particularly in the postoperative phase has been deemed desirable in patients with surgery in this region, particularly in those subjected to prolonged procedures and critical care.
The posterior fossa is an anatomically constricted compartment with narrow spaces and intracranial hypertension quickly leads to brainstem damage and neurological dysfunction. ICP in the supratentorial space not necessarily correlates with ICP in the infratentorial space. Some authors claim that it would be beneficial to measure ICP in infratentorial space after posterior fossa surgery in some cases.
The relationship between the intracranial pressure profiles in the supratentorial and infratentorial compartments remain unclear. After a neurosurgical operation in the posterior fossa there are most likely pressure differences between supra- and infratentorial spaces. It is well known that the pressure within the skull is unevenly distributed, with appreciable ICP gradients.
Thus, the investigators intend to apply the intracranial multimodal monitoring in both infratentorial and supratentorial compartments simultaneously. Such coincident measurements most likely will be the most sensitive way to assess focal swelling, ischemia and tissue perfusion, or other relevant complications in the posterior fossa structures.
The goal of this study is to test whether direct infratentorial monitoring is a more efficacious method for detecting dynamic changes in the operative compartment and whether it is safe, in view of the critical structures within the region.
연구 개요
상세 설명
Invasive neuromonitoring of intracranial pressure (ICP) is an important element of neurosurgical critical care that is used primarily as an indicator of adequate cerebral perfusion in patients, when clinical observation is not an option. Due to the constraint in size and the critical structures within the posterior fossa, continuous detection of postoperative pressures has been deemed desirable in patients with surgery in this region, particularly in those subjected to prolonged procedures and critical care.
The posterior fossa is an anatomically constricted compartment with narrow spaces and intracranial hypertension quickly leads to brainstem damage and neurological dysfunction. ICP in the supratentorial space not necessarily correlates with ICP in the infratentorial space. Some authors claim that it would be beneficial to measure ICP in infratentorial space after posterior fossa surgery in some cases.
In patients whose neurological examination results may be inconclusive or limited, it is valuable to have a reliable alternative method of evaluation. It is generally accepted that continuous ICP monitoring is very important to determine the timing of surgery and to prevent secondary brain damage caused by increased ICP.
There have been few clinical studies in which simultaneous pressures were recorded above and below the tentorium in patients with intracranial pathology. Yet, the relevance of infratentorial neuromonitoring remains largely unclear. So far, the placement of ICP probes in the posterior fossa seems to carry very low morbidity. Furthermore, to rely on autonomic changes, neurological deterioration, or measurements of only the supratentorial compartment as a sign of relevant complications in the posterior fossa highly narrows the temporal margin of safety for the institution of treatment. Comprehensive evaluation of possible risks of posterior fossa lesions and their treatments is crucial. Of note, immediate detection of treatment-related complications is often challenging, still being able to avoid permanent neurological sequelae. The application of the advanced neuromonitoring in the posterior fossa may be supportive in achieving this difficult goal and may provide objective assessments of procedure-related complications.
Therefore, the data generated by our prospective trial can be expected to be beneficial in individualized treatment plans. It is a relatively novel approach to intracranial multimodal neuromonitoring. The application of infratentorial probes offers potential for better understanding of lesion maturation and progression, clinical deterioration, and monitoring the effect of treatments.
The investigators hypothesize that additional multimodal infratentorial neuromonitoring will be of high clinical value detecting any relevant complication and giving detailed insight in pathophysiological interactions in posterior fossa lesions.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ondra Petr, MD PhD
- 전화번호: 81286 +43 512 504
- 이메일: ondra.petr@i-med.ac.at
연구 연락처 백업
- 이름: Thomas Petutschnigg
- 이메일: thomas.petutschnigg@student.i-med.ac.at
연구 장소
-
-
Tirol
-
Innsbruck, Tirol, 오스트리아, 6020
- 모병
- Medical University of Innsbruck
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Posterior fossa lesions with anticipated prolonged neurointensive critical care
- Patients older than 18 years
- Informed consent if applicable (unconscious patients will be also enrolled)
- No existing exclusion criteria
Exclusion Criteria:
- Coagulation disorders
- Age < 18 years
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Acute posterior fossa lesions
Subjects will receive additional multimodal infratentorial neuromonitoring
|
Multimodal neuromonitoring accounts for intraparenchymatous ICP probe, brain tissue oxygen probe and/or cerebral microdialysis device
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of device-related events [Safety and Tolerability]
기간: From implementation until removing of infratentorial multimodal neuromonitoring, assessed up to 30 days
|
All device-related events (infections, tissue irritation, haemorrhage along device trajectory, dural leaks etc.) will be noted and reported, even if no clinical consequence will ensue
|
From implementation until removing of infratentorial multimodal neuromonitoring, assessed up to 30 days
|
|
Correlation
기간: As long as neuromonitoring is indicated, assessed up to 30 days
|
Correlation analysis of supra- and infratentorial measures
|
As long as neuromonitoring is indicated, assessed up to 30 days
|
|
Glasgow Outcome Scale (GOS) after 3 months
기간: Assessed 3 months after initial treatment
|
GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome)
|
Assessed 3 months after initial treatment
|
|
Glasgow Outcome Scale (GOS) after 6 months
기간: Assessed 6 months after initial treatment
|
GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome)
|
Assessed 6 months after initial treatment
|
|
Glasgow Outcome Scale (GOS) after 9 months
기간: Assessed 9 months after initial treatment
|
GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome)
|
Assessed 9 months after initial treatment
|
|
modified Ranking Scale (mRS) after 3 months
기간: Assessed 3 months after initial treatment
|
mRS as alternative outcome measure to asses the potential influence of infratentorial monitoring measures on clinical outcome (mRS 0-6; the higher the worse the outcome)
|
Assessed 3 months after initial treatment
|
|
modified Ranking Scale (mRS) after 6 months
기간: Assessed 6 months after initial treatment
|
mRS as alternative outcome measure to asses the potential influence of infratentorial monitoring measures on clinical outcome (mRS 0-6; the higher the worse the outcome)
|
Assessed 6 months after initial treatment
|
|
modified Ranking Scale (mRS) after 9 months
기간: Assessed 9 months after initial treatment
|
mRS as alternative outcome measure to asses the potential influence of infratentorial monitoring measures on clinical outcome (mRS 0-6; the higher the worse the outcome)
|
Assessed 9 months after initial treatment
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ondra Petr, MD PhD, Consultant - Faculty/Staff
간행물 및 유용한 링크
일반 간행물
- Slavin KV, Misra M. Infratentorial intracranial pressure monitoring in neurosurgical intensive care unit. Neurol Res. 2003 Dec;25(8):880-4.
- Khan A, Borg N, Shenouda E. Posterior fossa ICP monitoring: a tale of two compartments. Br J Neurosurg. 2021 Apr;35(2):129-132. doi: 10.1080/02688697.2020.1765974. Epub 2020 May 15.
- Rosenwasser RH, Kleiner LI, Krzeminski JP, Buchheit WA. Intracranial pressure monitoring in the posterior fossa: a preliminary report. J Neurosurg. 1989 Oct;71(4):503-5.
- Moyse E, Ros M, Marhar F, Swider P, Schmidt EA. Characterisation of Supra- and Infratentorial ICP Profiles. Acta Neurochir Suppl. 2016;122:37-40. doi: 10.1007/978-3-319-22533-3_7.
- LANGFITT TW, WEINSTEIN JD, KASSELL NF, SIMEONE FA. TRANSMISSION OF INCREASED INTRACRANIAL PRESSURE. I. WITHIN THE CRANIOSPINAL AXIS. J Neurosurg. 1964 Nov;21:989-97. doi: 10.3171/jns.1964.21.11.0989. No abstract available.
- Wolfla CE, Luerssen TG, Bowman RM, Putty TK. Brain tissue pressure gradients created by expanding frontal epidural mass lesion. J Neurosurg. 1996 Apr;84(4):642-7.
- Vanaclocha V, Saiz-Sapena N, Rivera-Paz M, Herrera JM, Ortiz-Criado JM, Verdu-Lopez F, Vanaclocha L. Can we safely monitor posterior fossa intracranial pressure? A cadaveric study. Br J Neurosurg. 2017 Oct;31(5):557-563. doi: 10.1080/02688697.2017.1332336. Epub 2017 May 25.
- Rosner MJ, Becker DP. ICP monitoring: complications and associated factors. Clin Neurosurg. 1976;23:494-519.
- Maas AI, Schouten JW, Stocchetti N, Bullock R, Ghajar J. Questioning the value of intracranial pressure (ICP) monitoring in patients with brain injuries. J Trauma. 2008 Oct;65(4):966-7. doi: 10.1097/TA.0b013e318184ee7b. No abstract available.
- Saul TG, Ducker TB. Effect of intracranial pressure monitoring and aggressive treatment on mortality in severe head injury. J Neurosurg. 1982 Apr;56(4):498-503. doi: 10.3171/jns.1982.56.4.0498.
- Piek J, Bock WJ. Continuous monitoring of cerebral tissue pressure in neurosurgical practice--experiences with 100 patients. Intensive Care Med. 1990;16(3):184-8. doi: 10.1007/BF01724800.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NCH -11112018
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Multimodal neuromonitoring에 대한 임상 시험
-
Barretos Cancer HospitalM.D. Anderson Cancer Center; William Marsh Rice University; Irmandade Santa Casa de Misericórdia...모병
-
Nova Scotia Health AuthorityCanadian Institutes of Health Research (CIHR); Nova Scotia Health Research Foundation모병
-
Children's Hospital Medical Center, Cincinnati모집하지 않고 적극적으로
-
Istinye University모집하지 않고 적극적으로오스테 오르트 리트 | Eras protokolü | 총 Diz Artroplastisi칠면조
-
Germans Trias i Pujol Hospital완전한
-
Stéphanie ChevalierCanadian Institutes of Health Research (CIHR)모병