Value of Non Invasive Hemodynamic Monitoring in Patients Admitted to Respiratory Intensive Care Unit

NCT06110013 | Unknown FDA Device

• 1 other identifier: Hemodynamic monitoring
• Study Type: observational
• Target: 177
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate clinical application of electrical cardiometry EC in patients admitted to respiratory ICU. It will evaluate the reliability of EC in assessment of hemodynamic changes in these patients. It will estimate the effect of mechanical ventilation either invasive or non invasive hemodynamic parameters in patients admitted to ICU with respirator disorders

Conditions

Non-invasive Hemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

• Effectiveness of non invasive hemodynamic monitoring

  Effectiveness of clinical application of non invasive hemodynamic monitoring using electrical cardiometer in patients admitted to respiratory intensive care unit

  Baseline

Study Arms (3)

A

Patients on invasive mechanical ventilation

Device: Electrical cardiometry

B

Patients on Non invasive mechanical ventilation

Device: Electrical cardiometry

C

Patients Not on mechanical ventilation

Device: Electrical cardiometry

Interventions

Electrical cardiometry DEVICE

All included patients will be connected to Electrical cardiometry device. The electrodes will be placed over the bare skin of patients at the following sites: A. on the left neck below the ear B. directly superior to the midpoint of the left clavicle C. along the left mid-axillary line at the level of the xiphoid process D. two inches below the third electrode. High frequency signals pass through 2 acting electrodes, the other 2 measuring electrodes detect changes in bioimpedance resistance to allow continuous hemodynamic monitoring, then data will be analysed to give comprehensive picture of the hemodynamic circulatory system, allowing differential diagnosis for a patient management

Also known as: ICON

A; B; C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to respiratory intensive care unit (ICU)

You may qualify if:

• All patients admitted to respiratory intensive care unit (ICU) among both sexes Age \>18 years Old.

You may not qualify if:

• Patients less than 18 years old .
• Pregnant women.
• Patients with injuries, burns, or wounds which precluded the proper application of the device electrodes will be also excluded from the study.
• those with uncontrollable fits.
• Patients who need electrical direct current (DC) shock.
• Patients who refuse to participate in the study.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Masip J. Non-invasive ventilation. Heart Fail Rev. 2007 Jun;12(2):119-24. doi: 10.1007/s10741-007-9012-7.

  PMID: 17492379 RESULT

• Russell A, Rivers EP, Giri PC, Jaehne AK, Nguyen HB. A Physiologic Approach to Hemodynamic Monitoring and Optimizing Oxygen Delivery in Shock Resuscitation. J Clin Med. 2020 Jun 30;9(7):2052. doi: 10.3390/jcm9072052.

  PMID: 32629778 RESULT

• Nagel JH, Shyu LY, Reddy SP, Hurwitz BE, McCabe PM, Schneiderman N. New signal processing techniques for improved precision of noninvasive impedance cardiography. Ann Biomed Eng. 1989;17(5):517-34. doi: 10.1007/BF02368071.

  PMID: 2610423 RESULT

Central Study Contacts

Fatma S Ahmed

CONTACT

0201126921373; fatmasayed389@gmail.com

Mohamed G Abdelrahman

CONTACT

+201026600071; dr.mga2011@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 31, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10