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OpenTrials
Completed

NCT Number: NCT03525743

Cardiac Output Monitoring in Critically Ill Patient Undergoing Intubation

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

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NICOM (Non invasive cardiac output monitor)

Device

Non invasive hemodynamic device utilizing bioreactance

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 16, 2018
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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