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Cardiac Output Monitoring in Critically Ill Patient Undergoing Intubation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03525743
Enrollment
28
Registered
2018-05-16
Start date
2018-06-27
Completion date
2019-03-29
Last updated
2022-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

Intubation

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.

Interventions

DEVICENICOM (Non invasive cardiac output monitor)

Non invasive hemodynamic device utilizing bioreactance

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in cardiac output in critically ill patients undergoing endotracheal intubation10 minutes pre intubation,10 minutes post intubationchange in cardiac output as measured in liters/minute

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026