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CompletedNCT03525743Updated Sep 1, 2022

Cardiac Output Monitoring in Critically Ill Patient Undergoing Intubation

An observational study in Hypotension, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-01.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
28
Ages
18 Years and older
Sex
All
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Study summary

Collect hemodynamic data, such as heart rate, blood pressure, and cardiac output to help understand the effect of pre and post intubation.

Read the 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.

02

Conditions studied

  • Hypotension

Browse trials for

Keywords

  • Intubation
03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 28 is below the median of 84 across 294 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients in the intensive care unit.

Inclusion criteria

  • Patients requiring endotracheal intubation in the intensive care unit.

Exclusion criteria

Exclusion Criteria:

  • Patients previously enrolled in this study.
  • Patients requiring intubation outside of the intensive care unit.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
28 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Device: NICOM (Non invasive cardiac output monitor)

Interventions

  • DeviceNICOM (Non invasive cardiac output monitor)

    Non invasive hemodynamic device utilizing bioreactance

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What researchers measure

Primary outcomes

  1. Change in cardiac output in critically ill patients undergoing endotracheal intubation

    change in cardiac output as measured in liters/minute

    Time frame: 10 minutes pre intubation,10 minutes post intubation

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Study locations

2 sites
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • New York University Tisch Hospital
    New York, New York 10016, United States
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References and documents

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. PubMed 26117220 ↗
  • 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. PubMed 24424005 ↗
  • 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. PubMed 26831818 ↗
  • 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. PubMed 22743378 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03525743
Lead sponsor
Mayo Clinic
Responsible party
Nathan J. Smischney (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
May 16, 2018
Start date
Jun 27, 2018
Primary completion
Mar 29, 2019
Completion
Mar 29, 2019
Last update
Sep 1, 2022

Study contacts

Nathan Smischney, MD
principal investigator · Mayo Clinic

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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