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Clinical Trials/NCT01516697
NCT01516697
Withdrawn
Phase 4

Using Thoracic Electrical Bioimpedance to Measure Stroke Volume and Cardiac Output in Patients Under Spinal Anesthesia for Cesarean Section

Massachusetts General Hospital1 site in 1 countryOctober 2011

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Complications; Cesarean Section
Sponsor
Massachusetts General Hospital
Locations
1
Primary Endpoint
Maximum percentage changes in mean blood pressure after spinal anesthesia
Status
Withdrawn
Last Updated
9 years ago

Overview

Brief Summary

The investigators hypothesize that continuously measuring stroke volume (SV) and cardiac output (CO) will 1) reveal hemodynamic instability in a timely manner and alert the physician promptly, 2) provide information for the physician to make the differential diagnosis as to whether the hemodynamic instability was due to vasodilatation or reduction of venous blood return, and 3) lead to appropriate and prompt treatment to improve patient outcome.

-determine the SV and CO and their kinetic change using ICON® to establish a hemodynamic profile of the patient under spinal anesthesia for cesarean section. To determine if using instantaneous measurements of SV and CO to guide patient management improves hemodynamic stability.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
September 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yandong Jiang

Assistant professor

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • age 18-45;
  • receiving spinal anesthesia or combined spinal and epidural anesthesia to undergo cesarean section

Exclusion Criteria

  • Patients who have major cardiovascular disease,preexisting of hypertension or gestational hypertension, preeclampsia and body mass index greater than 35kg/m2;
  • Patients who have skin lesion at the place where the electrode is supposed to be applied;
  • Emergency cesarean section patients.

Outcomes

Primary Outcomes

Maximum percentage changes in mean blood pressure after spinal anesthesia

Time Frame: baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia

Study Sites (1)

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