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采用非侵入性方法对健康受试者的颅内顺应性进行特征描述——一项多中心前瞻性观察研究的结果。

Characterization of intracranial compliance in healthy subjects using a noninvasive method - results from a multicenter prospective observational study.

机构信息

Braincare Desenvolvimento e Inovação Tecnológica S.A., Bruno Ruggiero Filho Avenue, 971, São Carlos, São Paulo, 13562-420, Brazil.

Health Sciences Postgraduation Program, Federal University of Amazonas, General Rodrigo Octavio Jordão Ramos Avenue, 1200, Manaus, Amazonas, 69067-005, Brazil.

出版信息

J Clin Monit Comput. 2024 Dec;38(6):1249-1261. doi: 10.1007/s10877-024-01191-w. Epub 2024 Jul 20.

DOI:10.1007/s10877-024-01191-w
PMID:39031230
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11604689/
Abstract

PURPOSE

An FDA-approved non-invasive intracranial pressure (ICP) monitoring system enables the assessment of ICP waveforms by revealing and analyzing their morphological variations and parameters associated with intracranial compliance, such as the P2/P1 ratio and time-to-peak (TTP). The aim of this study is to characterize intracranial compliance in healthy volunteers across different age groups.

METHODS

Healthy participants, both sexes, aged from 9 to 74 years old were monitored for 5 min in the supine position at 0º. Age was stratified into 4 groups: children (≤ 7 years); young adults (18 ≤ age ≤ 44 years); middle-aged adults (45 ≤ age ≤ 64 years); older adults (≥ 65 years). The data obtained was the non-invasive ICP waveform, P2/P1 ratio and TTP.

RESULTS

From December 2020 to February 2023, 188 volunteers were assessed, of whom 104 were male, with a median (interquartile range) age of 41 (29-51), and a median (interquartile range) body mass index of 25.09 (22.57-28.04). Men exhibited lower values compared to women for both the P2/P1 ratio and TTP (p < 0.001). There was a relative rise in both P2/P1 and TTP as age increased (p < 0.001).

CONCLUSIONS

The study revealed that the P2/P1 ratio and TTP are influenced by age and sex in healthy individuals, with men displaying lower values than women, and both ratios increasing with age. These findings suggest potential avenues for further research with larger and more diverse samples to establish reference values for comparison in various health conditions.

TRIAL REGISTRATION

Brazilian Registry of Clinical Trials (RBR-9nv2h42), retrospectively registered 05/24/2022. UTN: U1111-1266-8006.

摘要

目的

经美国食品药品监督管理局批准的非侵入性颅内压(ICP)监测系统能够通过揭示和分析其形态变化以及与颅内顺应性相关的参数来评估 ICP 波形,例如 P2/P1 比值和达峰时间(TTP)。本研究旨在描述不同年龄组健康志愿者的颅内顺应性。

方法

本研究纳入了 9 至 74 岁的健康志愿者,在 0°仰卧位监测 5 分钟。将年龄分为 4 组:儿童(≤7 岁);年轻成年人(18≤年龄≤44 岁);中年成年人(45≤年龄≤64 岁);老年人(≥65 岁)。获得的数据为非侵入性 ICP 波形、P2/P1 比值和 TTP。

结果

2020 年 12 月至 2023 年 2 月期间,共评估了 188 名志愿者,其中 104 名为男性,中位(四分位间距)年龄为 41(29-51)岁,中位(四分位间距)体重指数为 25.09(22.57-28.04)。男性的 P2/P1 比值和 TTP 值均低于女性(p<0.001)。随着年龄的增长,P2/P1 和 TTP 均呈相对升高趋势(p<0.001)。

结论

本研究表明,在健康个体中,P2/P1 比值和 TTP 受年龄和性别影响,男性的数值低于女性,且两种比值均随年龄增长而增加。这些发现为进一步研究提供了线索,需要更大、更多样化的样本,以建立各种健康状况下的参考值进行比较。

试验注册

巴西临床试验注册处(RBR-9nv2h42),于 2022 年 5 月 24 日回溯注册。UTN:U1111-1266-8006。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4b1/11604689/7c9471cbd54c/10877_2024_1191_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4b1/11604689/e9dd44eafbd4/10877_2024_1191_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4b1/11604689/4365888bc234/10877_2024_1191_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4b1/11604689/edb8f3406f6b/10877_2024_1191_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4b1/11604689/7c9471cbd54c/10877_2024_1191_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4b1/11604689/e9dd44eafbd4/10877_2024_1191_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4b1/11604689/2bec75bb6290/10877_2024_1191_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4b1/11604689/3bfb2a7fd0a2/10877_2024_1191_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4b1/11604689/4365888bc234/10877_2024_1191_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4b1/11604689/edb8f3406f6b/10877_2024_1191_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4b1/11604689/7c9471cbd54c/10877_2024_1191_Fig6_HTML.jpg

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