Cardiac Output Monitoring in Critically Ill Patient Undergoing Intubation
Non-invasive Cardiac Output Monitoring (NICOM) in Critically Ill Patient Undergoing Endotracheal Intubation in ICU
1 other identifier
observational
28
1 country
2
Brief Summary
Collect hemodynamic data, such as heart rate, blood pressure, and cardiac output to help understand the effect of pre and post intubation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2018
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2018
CompletedFirst Posted
Study publicly available on registry
May 16, 2018
CompletedStudy Start
First participant enrolled
June 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2019
CompletedSeptember 1, 2022
August 1, 2022
9 months
May 3, 2018
August 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in cardiac output in critically ill patients undergoing endotracheal intubation
change in cardiac output as measured in liters/minute
10 minutes pre intubation,10 minutes post intubation
Study Arms (1)
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.
Interventions
Non invasive hemodynamic device utilizing bioreactance
Eligibility Criteria
Patients in the intensive care unit.
You may qualify if:
- Patients requiring endotracheal intubation in the intensive care unit.
You may not qualify if:
- Patients previously enrolled in this study.
- Patients requiring intubation outside of the intensive care unit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
Mayo Clinic
Rochester, Minnesota, 55905, United States
New York University Tisch Hospital
New York, New York, 10016, United States
Related Publications (5)
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.
PMID: 26117220BACKGROUNDGreen 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.
PMID: 24424005BACKGROUNDSmischney 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.
PMID: 26831818BACKGROUNDSmischney 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.
PMID: 22743378BACKGROUNDSmischney NJ, Stoltenberg AD, Schroeder DR, DeAngelis JL, Kaufman DA. Noninvasive Cardiac Output Monitoring (NICOM) in the Critically Ill Patient Undergoing Endotracheal Intubation: A Prospective Observational Study. J Intensive Care Med. 2023 Dec;38(12):1108-1120. doi: 10.1177/08850666231183401. Epub 2023 Jun 15.
PMID: 37322892DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Smischney, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 3, 2018
First Posted
May 16, 2018
Study Start
June 27, 2018
Primary Completion
March 29, 2019
Study Completion
March 29, 2019
Last Updated
September 1, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share