- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00573274
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
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Elective cesarean section patients
|
6 ECG leads applied to the neck and thorax for the duration of surgery (approximately 1 hour).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Continuous measurement of cardiac output (CO), stroke volume (SV) and/or systemic vascular resistance (SVR) changes.
Time Frame: 60 minutes
|
60 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kong Eric You-Ten, MD, Mount Sinai Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-09
- 07-0225-E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypotension
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Edwards LifesciencesCompletedHypotension | Intraoperative Hypotension | Postoperative HypotensionNetherlands
-
James J. Peters Veterans Affairs Medical CenterCompleted
-
Attikon HospitalRecruitingHypotension During Surgery | Prevention of HypotensionGreece
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingHypotension Drug-Induced | Hypotension During Surgery
-
Universitätsklinikum Hamburg-EppendorfCompletedBlood Pressure | Postinduction Hypotension | Perioperative HypotensionGermany
-
University of ParmaUnknownHypotension During Dialysis | Dialysis HypotensionItaly
-
Peking Union Medical College HospitalRecruitingPost-induction Hypotension | Postprandial HypotensionChina
-
H. Lundbeck A/SCompletedSymptomatic Neurogenic Orthostatic HypotensionUnited States
-
Mazovia Regional Hospital in SiedlceRecruitingAnesthesia | Hypotension on Induction | Perioperative Injury | Perioperative HypotensionPoland
-
Acibadem UniversityCompletedHypotension | Intraoperative Hypotension | Post-induction Hypotension | Post Anesthesia RecoveryTurkey
Clinical Trials on Physioflow Impedance
-
University Hospital, Strasbourg, FranceCompletedCardiac Surgery With Extracorporeal CirculationFrance
-
University of California, San DiegoCompletedCongenital Heart DiseaseUnited States
-
University Hospital, LilleCompleted
-
University Hospital, Clermont-FerrandSport Medicine Department, CHU Clermont-Ferrand; Cardiology and Vascular Department...TerminatedCardiac Output | Congenital Heart Diseases | HemodynamicFrance
-
Mayo ClinicWithdrawnGastro-esophageal Reflux Disease (GERD)United States
-
Mayo ClinicWithdrawn
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)TerminatedExtensive Stage Small Cell Lung CancerUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | Adult Acute Myeloid Leukemia With Del(5q) | Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) | Untreated Adult Acute Myeloid... and other conditionsUnited States
-
Mayo ClinicSandhill ScientificCompletedHealthy | Eosinophilic EsophagitisUnited States
-
Ohio State University Comprehensive Cancer CenterNot yet recruitingMalignant Solid Neoplasm | Lymphedema | Hematopoietic and Lymphoid System NeoplasmUnited States