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Undetectable Hypotension Episodes in Cesarean Section

NCT05440695 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 53

Last updated 2022-07-01

No results posted yet for this study

Summary

In order to evaluate the efficacy and necessity of continuous non-invasive arterial pressure (CNAP) by comparing it with non-invasive blood pressure (NIBP) in order to understand whether it has advantages over oscillometric technique for detection of hypotensive episodes in healthy pregnant women who underwent cesarean section (C/S) under neuraxial anesthesia. This prospective study will evaluate healthy pregnant women at term, who were scheduled for elective C/S under spinal anesthesia. Subjects were randomly assigned into 2 groups to receive either CNAP and NIBP or only NIBP. A thirty percent decrease in systolic blood pressure from either baseline or the measured values in the first two minutes, or if the systolic blood pressure was less than 90mmHg, is considered hypotension. Pre-, peri- and post-operative specifications, newborn characteristics, and complications were recorded and compared.

Conditions

  • Pregnancy Related
  • Anesthesia
  • Blood Pressure

Interventions

DEVICE

Continuous non-invasive arterial pressure (Infinity® CNAPTM, Dräger)

The basic working principle of CNAP is to keep the blood volume of the finger arteries constant by applying an exterior pressure to the vessel wall, that is done by an electronic system controlling the pressure inside a cuff around the finger. The pressure in the cuff, which is needed to keep the volume constant during arterial pulsation, corresponds to the AP.

Sponsors & Collaborators

  • Asude AYHANt

    lead OTHER

Principal Investigators

  • Aynur C FIRAT, M.D. · Baskent University School of Medicine, Department of Anaesthesiology and Reanimation

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-01
Primary Completion
2014-08-01
Completion
2015-02-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05440695 on ClinicalTrials.gov