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Набор скоро начнётся NCT07458893

Prediction of Post-Induction Hypotension Using Plethysmographic Variability Index During Diagnostic Laryngoscopy

— Наблюдательное Post-Induction Hypotension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Plethysmographic Variability Index (PVI) and Perfusion Index (PI) Monitoring.
Кому может быть актуально
Состояния в реестре: Post-Induction Hypotension. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prediction of Post-Induction Hypotension Using the Plethysmographic Variability Index in Patients Undergoing Diagnostic Laryngoscopy Under General Anesthesia

Обзор

This prospective observational study aims to evaluate whether non-invasive hemodynamic parameters, including the plethysmographic variability index (PVI) and perfusion index (PI), can predict post-induction hypotension in patients undergoing diagnostic direct laryngoscopy under general anesthesia. Patients aged 18-75 years with ASA physical status I-III scheduled for elective direct laryngoscopy will be included. PVI and PI values will be recorded before anesthesia induction and in the early post-induction period. The relationship between these indices and the decrease in mean arterial pressure after induction will be analyzed to determine their predictive value for hypotension.

Подробное описание

Post-induction hypotension is a common hemodynamic complication during the early phase of general anesthesia and may lead to adverse perioperative outcomes, particularly in patients with limited physiological reserve. Early identification of patients at risk for hypotension may allow clinicians to implement preventive strategies and optimize perioperative hemodynamic management. Recently, non-invasive perfusion-related parameters derived from pulse oximetry have gained attention as potential indicators of intravascular volume status and cardiovascular responsiveness.

The plethysmographic variability index (PVI) is a dynamic parameter reflecting respiratory variations in the perfusion index and is considered a non-invasive surrogate marker of fluid responsiveness. The perfusion index (PI), which represents the ratio of pulsatile to non-pulsatile blood flow in peripheral tissues, provides information about peripheral perfusion and vascular tone. These indices are continuously and non-invasively obtained using pulse oximetry and may offer clinically useful information regarding hemodynamic status during anesthesia induction.

Direct laryngoscopy performed under general anesthesia may be associated with significant hemodynamic fluctuations during both the induction phase and airway manipulation. Identifying reliable non-invasive predictors of blood pressure reduction during this period may improve intraoperative monitoring and facilitate early intervention.

Вмешательства

  • Устройство Plethysmographic Variability Index (PVI) and Perfusion Index (PI) Monitoring
    Non-invasive monitoring of plethysmographic variability index (PVI) and perfusion index (PI) will be performed using pulse oximetry during the peri-induction period in patients undergoing diagnostic direct laryngoscopy under general anesthesia. These parameters will be recorded before anesthesia induction and during the early post-induction phase to evaluate their association with changes in mean arterial pressure and their predictive value for post-induction hypotension.

Первичные конечные точки

  • Change in Mean Arterial Pressure (ΔMAP) After Anesthesia Induction and Its Association With Plethysmographic Variability Index (PVI) and Perfusion Index (PI) [Срок оценки: From baseline before induction to 5 minutes after anesthesia induction.]

Критерии участия

Критерии включения

  • Scheduled to undergo elective direct laryngoscopy under general anesthesia Body mass index (BMI) between 18 and 40 kg/m² ASA physical status classification I-III Provision of written informed consent after being informed about the study

Критерии исключения

  • Severe arrhythmias Advanced heart failure Severe valvular heart disease Preoperative shock or hemodynamic instability requirement for continuous vasopressor or inotropic infusion Significant peripheral vascular disease affecting peripheral circulation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07458893 · 2026/76

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗