NCT03525743

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
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypotension

Interventions

Type	Name	Description
DEVICE	NICOM (Non invasive cardiac output monitor)	Non invasive hemodynamic device utilizing bioreactance

Timeline

• Start date: 2018-06-27
• Primary completion: 2019-03-29
• Completion: 2019-03-29
• First posted: 2018-05-16
• Last updated: 2022-09-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study