Cardiac Output Monitoring in Critically Ill Patient Undergoing Intubation

NCT ID: NCT03525743

Last Updated: 2022-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-27

Study Completion Date

2019-03-29

Brief Summary

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

Detailed Description

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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

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Hypotension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

NICOM (Non invasive cardiac output monitor)

Intervention Type DEVICE

Non invasive hemodynamic device utilizing bioreactance

Interventions

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NICOM (Non invasive cardiac output monitor)

Non invasive hemodynamic device utilizing bioreactance

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Nathan J. Smischney

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nathan Smischney, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

New York University Tisch Hospital

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26117220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24424005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26831818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22743378 (View on PubMed)

Smischney 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.

Reference Type DERIVED
PMID: 37322892 (View on PubMed)

Related Links

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Other Identifiers

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16-006354

Identifier Type: -

Identifier Source: org_study_id

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