Cardiac Output Monitoring in Critically Ill Patient Undergoing Intubation

Completed

• Conditions: Hypotension
• Interventions: Device: NICOM (Non invasive cardiac output monitor)

• Registration Number: NCT03525743
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-16
• Study Start: 2018-06-27
• Primary Completion: 2019-03-29
• Study Completion: 2019-03-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing intubation	NICOM (Non invasive cardiac output monitor)	Adhesive gel pads will be placed on patient to measure continuous cardiac output and to calculate stroke volume variation. Other physiologic data will be analyzed in real time using the NICOM (Non invasive cardiac output monitor) device.

Primary Outcome Measures

Name	Time	Method
Change in cardiac output in critically ill patients undergoing endotracheal intubation	10 minutes pre intubation,10 minutes post intubation	change in cardiac output as measured in liters/minute

Trial Locations

Locations (2)

New York University Tisch Hospital; 🇺🇸 New York, New York, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States