NCT04195087

Brief Summary

The aim of this study is to investigate the predictability of hypotension by using PI and PVI in pre-and post-spinal anesthesia periods in cesarean section cases in the sitting position.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 2, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

December 2, 2019

Last Update Submit

July 8, 2020

Conditions

Cesarean Section Complications

Keywords

cesarean sectionperfusion indexPleth variability indexsitting position

Outcome Measures

Primary Outcomes (10)

  • Perfusion index

    Perfusion index will be recorded from the monitor.

    Before spinal anesthesia in supine positon

  • Pleth variability index

    Pleth variability index will be recorded from the monitor.

    Before spinal anesthesia in supine positon

  • Perfusion index

    Perfusion index will be recorded from the monitor.

    Before spinal anesthesia in sitting positon

  • Pleth variability index

    Pleth variability index will be recorded from the monitor.

    Before spinal anesthesia in sitting positon

  • Perfusion index

    Perfusion index will be recorded from the monitor.

    1 minutes after spinal anesthesia in supine positon

  • Pleth variability index

    Pleth variability index will be recorded from the monitor.

    1 minutes after spinal anesthesia in supine positon

  • Perfusion index

    Perfusion index will be recorded from the monitor.

    Start of the surgery

  • Pleth variability index

    Pleth variability index will be recorded from the monitor.

    Start of the surgery

  • Perfusion index

    Perfusion index will be recorded from the monitor.

    1 minutes after the umbilical cord clamping

  • Pleth variability index

    Pleth variability index will be recorded from the monitor.

    1 minutes after the umbilical cord clamping

Study Arms (2)

Non-hypotension

Patients with a mean arterial pressure reduction of less than 20% and/or systolic arterial pressure above 80 mmHg after spinal anesthesia.

Device: Masimo Radical-7® Pulse CO-Oximeter®

Hypotension

Patients with a 20% reduction in mean arterial pressure and/or systolic arterial pressure below 80 mmHg after spinal anesthesia.

Device: Masimo Radical-7® Pulse CO-Oximeter®

Interventions

Masimo Radical-7® Pulse CO-Oximeter®DEVICE

The perfusion index and Pleth variability index will be recorded from the device monitor.

HypotensionNon-hypotension

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women who will undergo elective cesarean section

You may qualify if:

  • Pregnant women who will undergo elective cesarean section

You may not qualify if:

  • Preeclampsia
  • Cardiovascular disorder
  • Fetal abnormality
  • Patients who failed spinal anesthesia or switched to general anesthesia during operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Antalya Training and Research Hospital

Antalya, 07100, Turkey (Türkiye)

Location

Study Officials

  • Erhan OZYURT, MD

    University of Health Sciences, Antalya Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study director

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 11, 2019

Study Start

December 2, 2019

Primary Completion

January 31, 2020

Study Completion

February 28, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

TU(1)