Cardiac Output Monitoring in Critically Ill Patient Undergoing Intubation
August 30, 2022 updated by: Nathan J. Smischney, Mayo Clinic
Non-invasive Cardiac Output Monitoring (NICOM) in Critically Ill Patient Undergoing Endotracheal Intubation in ICU
Collect hemodynamic data, such as heart rate, blood pressure, and cardiac output to help understand the effect of pre and post intubation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
New York
-
New York, New York, United States, 10016
- New York University Tisch Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients in the intensive care unit.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients undergoing intubation
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.
|
Non invasive hemodynamic device utilizing bioreactance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
10 minutes pre intubation,10 minutes post intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nathan Smischney, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Green RS, Turgeon AF, McIntyre LA, Fox-Robichaud AE, Fergusson DA, Doucette S, Butler MB, Erdogan M; Canadian Critical Care Trials Group (CCCTG). Postintubation hypotension in intensive care unit patients: A multicenter cohort study. J Crit Care. 2015 Oct;30(5):1055-60. doi: 10.1016/j.jcrc.2015.06.007. Epub 2015 Jun 16.
- Green R, Hutton B, Lorette J, Bleskie D, McIntyre L, Fergusson D. Incidence of postintubation hemodynamic instability associated with emergent intubations performed outside the operating room: a systematic review. CJEM. 2014 Jan;16(1):69-79. doi: 10.2310/8000.2013.131004.
- Smischney NJ, Demirci O, Diedrich DA, Barbara DW, Sandefur BJ, Trivedi S, McGarry S, Kashyap R. Incidence of and Risk Factors For Post-Intubation Hypotension in the Critically Ill. Med Sci Monit. 2016 Feb 2;22:346-55. doi: 10.12659/msm.895919.
- Smischney NJ, Beach ML, Loftus RW, Dodds TM, Koff MD. Ketamine/propofol admixture (ketofol) is associated with improved hemodynamics as an induction agent: a randomized, controlled trial. J Trauma Acute Care Surg. 2012 Jul;73(1):94-101. doi: 10.1097/TA.0b013e318250cdb8.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2018
Primary Completion (Actual)
March 29, 2019
Study Completion (Actual)
March 29, 2019
Study Registration Dates
First Submitted
May 3, 2018
First Submitted That Met QC Criteria
May 3, 2018
First Posted (Actual)
May 16, 2018
Study Record Updates
Last Update Posted (Actual)
September 1, 2022
Last Update Submitted That Met QC Criteria
August 30, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-006354
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.