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Clinical Trials/NCT03525743
NCT03525743
Completed
N/A

Non-invasive Cardiac Output Monitoring (NICOM) in Critically Ill Patient Undergoing Endotracheal Intubation in ICU

Mayo Clinic2 sites in 1 country28 target enrollmentJune 27, 2018
ConditionsHypotension

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hypotension
Sponsor
Mayo Clinic
Enrollment
28
Locations
2
Primary Endpoint
Change in cardiac output in critically ill patients undergoing endotracheal intubation
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Collect hemodynamic data, such as heart rate, blood pressure, and cardiac output to help understand the effect of pre and post intubation.

Detailed Description

A Non-invasive physiologic monitor, Non-Invasive Cardiac Output Monitor (NICOM), will be utilized for this study. This is the first completely non-invasive hemodynamic device approved by the FDA and available for clinical use produced by Cheetah Medical and utilizes Bioreactance (Tel Aviv, Israel). It performs accurately and with precision in all patient's studied and requires only 4 adhesive gel pads on the skin to measure continuous cardiac output and to calculate Stroke Volume Variation (SVV). Other physiologic data (blood pressure, total peripheral resistance (TPR), stroke volume (SV), and heart rate) will be analyzed in real time and recorded on the device and downloaded into an excel database. The data on the device will be downloaded weekly onto the excel database and deleted on the device. The Study personnel will be trained in its use prior to study initiation.

Registry
clinicaltrials.gov
Start Date
June 27, 2018
End Date
March 29, 2019
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nathan J. Smischney

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Patients requiring endotracheal intubation in the intensive care unit.

Exclusion Criteria

  • Patients previously enrolled in this study.
  • Patients requiring intubation outside of the intensive care unit.

Outcomes

Primary Outcomes

Change in cardiac output in critically ill patients undergoing endotracheal intubation

Time Frame: 10 minutes pre intubation,10 minutes post intubation

change in cardiac output as measured in liters/minute

Study Sites (2)

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