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

December 12, 2007
July 29, 2009
November 2007
January 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00573274 on ClinicalTrials.gov Archive Site
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Measuring Cardiac Output and Stroke Volume Using the Physioflow Impedance Device in Pregnant Patients
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Healthy volunteers having an elective cesarean section.

Hypotension
Device: Physioflow Impedance
6 ECG leads applied to the neck and thorax for the duration of surgery (approximately 1 hour).
1
Elective cesarean section patients
Intervention: Device: Physioflow Impedance
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00573274
07-09, 07-0225-E
No
Dr. Eric Kong You-Ten, Mount Sinai Hospital
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Not Provided
Principal Investigator: Kong Eric You-Ten, MD Mount Sinai Hospital, New York
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP