Finger Plethysmography to Predict Fluid Responsiveness in Healthy Pregnancy and Severe Preeclampsia

N/ANot Yet RecruitingNCT07430254

Stanford University88 enrolled

Overview

The goal of this observational study is to determine whether noninvasive finger plethysmographic cardiac output monitoring can help predict fluid responsiveness in pregnant women, including those with preeclampsia with severe features. The main questions it aims to answer are : * Can changes in cardiac output measured by finger plethysmography predict fluid responsiveness? * How does this method perform compared with standard echocardiographic assessment? Participants will provide consent and undergo noninvasive hemodynamic monitoring and a brief reversible physiological challenge.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pre-Eclampsia, Severe Pregnancy

Interventions

Noninvasive finger plethysmographic cardiac output monitoringDIAGNOSTIC_TEST

Noninvasive hemodynamic monitoring used to assess changes in cardiac output for prediction of fluid responsiveneness

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women diagnosed with preeclampsia with severe features following ACOG recommendations (systolic/diastolic BP \>160/110 mmHg, proteinuria, or other severe features like headaches, visual disturbances, kidney/liver impairment, thrombocytopenia). * Healthy pregnant women at term (for comparison group, e.g., scheduled for elective Cesarean delivery). Exclusion Criteria: * Patients who can not provide written consent to participate in the study * BMI greater than 40 kg/m² * Multiple pregnancy (twins, triplets, etc.) * Non-reassuring fetal heart tracing * ≤ 22 weeks gestation * History of chronic arterial hypertension * Chronic kidney disease * Congenital or known acquired heart disease * Chronic obstructive pulmonary disease * Diabetes * History of stroke * Not tolerating passive leg raising (unable to be placed in the required study position) * No TTE-windows * Withdrawing consent * Emergency cesarean delivery

Outcomes

Primary Outcomes

Prediction Accuracy for Change in Cardiac Output for Fluid Responsiveness

Prediction accuracy (ROC-AUC) of percent change in cardiac output measured by noninvasive finger plethysmographic device during passive leg raising to identify fluid responsiveness (TTE reference)

Time frame: Baseline (semi-recumbent) and 1 minute after passive leg raising

Secondary Outcomes

Prediction Accuracy for Change in Pulsatility Index for Fluid Responsiveness

Prediction accuracy (ROC-AUC) of percent change in pulsatility index measured by noninvasive finger plethysmographic device during passive leg raising to identify fluid responsiveness (TTE reference)

Time frame: Baseline (semi-recumbent) and 1 minute after passive leg raising

Prediction Accuracy for Change in Stroke Volume for Fluid Responsiveness

Prediction accuracy (ROC-AUC) of percent change in stroke volume measured by noninvasive finger plethysmographic device during passive leg raising to identify fluid responsiveness (TTE reference)

Time frame: Baseline (semi-recumbent) and 1 minute after passive leg raising

Prediction accuracy for Pulsatility Index at Baseline

Prediction accuracy (ROC-AUC) of baseline pulsatility index measured by noninvasive finger plethysmographic device to identify fluid responsiveness (TTE reference)

Time frame: Baseline (semi-recumbent)

Prediction accuracy for Stroke Volume at Baseline

Prediction accuracy (ROC-AUC) of baseline stroke volume measured by noninvasive finger plethysmographic device to identify fluid responsiveness (TTE reference)

Time frame: Baseline (semi-recumbent)

Prediction accuracy for Cardiac Output at Baseline

Prediction accuracy (ROC-AUC) of baseline cardiac output measured by noninvasive finger plethysmographic device to identify fluid responsiveness (TTE reference)

Time frame: Baseline (semi-recumbent)

Optimal Diagnostic Cut-Off and Operating Characteristics for Device Parameters

Determination of optimal cut-off values and corresponding sensitivity, specificity, positive predictive value and negative predictive value for noninvasive finger plethysmographic device (TTE reference)

Time frame: Baseline (semi-recumbent) and 1 minute after passive leg raising

Inter-observer and Intra-observer Variability for Measurements

Inter-observer and intra-observer variability metrics for noninvasive finger plethysmographic device and for TTE.

Time frame: Baseline (semi-recumbent) and 1 minute after passive leg raising

Finger Plethysmography to Predict Fluid Responsiveness in Healthy Pregnancy and Severe Preeclampsia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts