Measuring Cardiac Output and Stroke Volume Using the Physioflow Impedance Device in Pregnant Patients

This study has been completed.
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00573274
First received: December 12, 2007
Last updated: July 29, 2009
Last verified: July 2009
  Purpose

Pregnant patients having a cesarean section (CS) under spinal anesthesia experience a variety of hemodynamic changes, such as hypotension due to decreases in cardiac output (CO), stroke volume (SV) and/or systemic vascular resistance (SVR). Measurement of these hemodynamic parameters classically requires insertion of a pulmonary artery catheter (PAC) into the heart. However, this invasive method carries significant complications and its use is now reserved for the more critically ill patients. We hypothesize that the Physioflow Impedance device can be used as a reliable non-invasive monitor to measure hemodynamic parameters during elective CS under spinal anesthesia.


Condition Intervention
Hypotension
Device: Physioflow Impedance

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study Measuring Cardiac Output and Stroke Volume Using Non-Invasive Thoracic Impedance With the Physioflow Impedance Device in Pregnant Patients Undergoing Cesarean Section Under Spinal Anesthesia

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • Continuous measurement of cardiac output (CO), stroke volume (SV) and/or systemic vascular resistance (SVR) changes. [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Elective cesarean section patients
Device: Physioflow Impedance
6 ECG leads applied to the neck and thorax for the duration of surgery (approximately 1 hour).

Detailed Description:

The Physioflow Impedance device employs a continuous non-invasive method of measuring ten cardiac hemodynamic parameters including flow, resistance, contractility and fluid content. It involves the application of electrocardiogram (ECG) leads on the neck and the thorax to measure resistance of pulsatile blood flow. Its benefits are that it is non-invasive, low cost, and easy to operate. Thoracic impedance has been validated against the gold standard method of PAC. Although the Physioflow device has been validated in non-pregnant patients, its use in pregnant patients is very limited.

Moderate to severe hypotension, experienced by these awake patients, can cause significant undesirable symptoms of dizziness, shortness of breath, nausea and vomiting, and also compromise fetal well-being. The etiology of hypotension is multi-factorial,and it is postulated that decreases in cardiac output (CO), stroke volume (SV) and/or systemic vascular resistance (SVR) may precede decreases in blood pressure. Continuous measurement of CO and SV by the Physioflow Impedance device may provide a better understanding of the cause of hypotension so that future management of these patients may include pharmacological interventions used prior to hypotension in order to avoid any undesirable symptoms.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy volunteers having an elective cesarean section.

Criteria

Inclusion Criteria:

  • Women undergoing elective cesarean section
  • Women classified as ASA 1 & 2

Exclusion Criteria:

  • Patients unable to communicate in English
  • Patients with significant cardiac disease
  • Height less than 4 feet or greater than 7 feet
  • Weight less than 67 lbs or greater than 341 lbs
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00573274

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Kong Eric You-Ten, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Dr. Eric Kong You-Ten, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00573274     History of Changes
Other Study ID Numbers: 07-09, 07-0225-E
Study First Received: December 12, 2007
Last Updated: July 29, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Cesarean section
Cardiac Output
Physioflow
Cardiography, Impedance

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014