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Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight

29 juni 2026 uppdaterad av: Ling-Qun Hu, Ohio State University

Comparative Analysis of the Predictive Performance of Noninvasive Beat-by-Beat Blood Pressure and Flow Measurements at the Lower Extremity Versus the Upper Extremity for Neonatal Outcomes Under Spinal Anesthesia for Elective Cesarean Delivery

This is a single-center, prospective observational study in patients undergoing cesarean delivery under spinal or combined spinal-epidural anesthesia. It compares whether continuous noninvasive hemodynamic measurements from the lower extremity (toe) better predict neonatal outcomes than upper extremity (arm/finger) measurements during spinal-induced hypotension.

Participants receive standard spinal anesthesia and routine blood pressure management, with additional monitoring using the ClearSight™ system at both upper and lower extremities from before spinal anesthesia through delivery.

The primary outcome is a composite of neonatal outcomes (APGAR scores, need for respiratory support, cord gases, and NICU admission). Secondary outcomes include maternal side effects and comfort.

Overall, the study evaluates whether lower-extremity hemodynamic monitoring improves detection of clinically relevant hypotension and prediction of neonatal outcomes compared to traditional arm measurements.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Enrolled parturients undergoing elective cesarean delivery under spinal anesthesia will participate in this prospective, observational study following informed consent. Standard perioperative care will be maintained, including administration of spinal anesthesia (1.6 mL of 0.75% hyperbaric bupivacaine with fentanyl 10 mcg and morphine 100 mcg), crystalloid co-loading, and a prophylactic phenylephrine infusion. For study purposes, the ClearSight™ system will be applied noninvasively to both the upper and lower extremities, with a finger cuff placed on the ring finger of the arm opposite the intravenous line and a toe cuff placed on the left foot, while a standard oscillometric blood pressure cuff will be placed on the same arm. Continuous beat-by-beat blood pressure and flow measurements will be recorded from 3 minutes prior to spinal anesthesia placement until 3 minutes after neonatal delivery, alongside routine intermittent arm cuff measurements. Intraoperative maternal events and hemodynamic parameters will be documented, and neonatal outcome data-including Apgar scores, need for airway support, and NICU admission-will be extracted from the electronic medical record. No additional interventions beyond standard care will be performed, and all data collected will be used to compare the predictive performance of upper versus lower extremity hemodynamic measurements for neonatal outcomes.

Studietyp

Observationell

Inskrivning (Beräknad)

327

Kontakter och platser

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Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Sannolikhetsprov

Studera befolkning

The study includes adults, children, English- or Spanish-speaking individuals, and pregnant women (and their fetuses). It excludes adults with impaired decision-making capacity, nonviable neonates, neonates of uncertain viability, and prisoners. Eligible participants must be ≥18 years old, able to provide consent in English or Spanish, and have a singleton pregnancy at ≥37 weeks gestation. Exclusion criteria include documented fetal anomalies, congenital malformations, or genetic conditions; unstable cardiac disease (other than hypertensive disorders of pregnancy) that may affect blood pressure; and intrauterine growth restriction. Prisoners and other vulnerable populations are excluded.

Beskrivning

Inclusion Criteria:

  • Age ≥ 18 years old
  • Singleton pregnancy
  • Gestational age ≥ 37 weeks
  • Women undergoing CD under SAB or Combined Spinal-Epidural (CSE) electively.
  • Ability to consent in English and in Spanish language

Exclusion Criteria:

  • CD under or converted to general anesthesia
  • CD under epidural anesthesia or converted to epidural anesthesia
  • Diabetes Mellitus (DM)/Gestational Diabetes Mellitus (GDM)
  • Evidence of unstable cardiac disease other than HDP (including chronic hypertension, gestational hypertension, preeclampsia-eclampsia, and chronic hypertension with superimposed preeclampsia) judged by the investigator to have any impact on BP will make the subject unsuitable for participation in the study
  • Documented fetal anomaly/ congenital malformations and genetic syndromes
  • Intrauterine growth retardation
  • Unable to consent in English/Spanish.
  • Prisoners

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Pregnant Women undergoing Cesarean Delivery
Enhet: ClearSight
The ClearSight system provides continuous blood pressure and advanced hemodynamic parameters from a noninvasive finger cuff sensor. Therefore, placing both cuff sensors in different arms will ensure no interference with the ClearSight readings due to the conventional blood pressure cuff inflation.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidences of FAAAN composite poor neonatal outcomes
Tidsram: 24 Hours after delivery
FAAAN is a composite neonatal outcome measure used in this study to capture clinically relevant indicators of neonatal well-being and immediate post-delivery support needs. It includes abnormal fetal heart rate patterns, Apgar scores at 1 and 5 minutes, requirement for fetal airway support (mask ventilation, supplemental oxygen, CPAP, or intubation), and NICU admission. The primary outcome is the incidence of a composite of poor neonatal outcomes, referred to as FAAAN. This composite includes abnormal fetal heart rate patterns, Apgar scores at 1 and 5 minutes, requirement for fetal airway support (mask ventilation, supplemental oxygen, CPAP, or intubation), NICU admission, cord blood gas abnormalities, and delayed cord clamping.
24 Hours after delivery

Sekundära resultatmått

Resultatmått
Tidsram
Maternal nausea/vomiting, arm, finger, and toe comfort, and shivering
Tidsram: 24 Hours after delivery
24 Hours after delivery

Samarbetspartners och utredare

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Sponsor

Ohio State University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 februari 2025

Primärt slutförande (Beräknad)

6 februari 2029

Avslutad studie (Beräknad)

6 augusti 2029

Studieregistreringsdatum

Först inskickad

29 juni 2026

Först inskickad som uppfyllde QC-kriterierna

29 juni 2026

Första postat (Faktisk)

6 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2024H0319

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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