Correlation Between Changes in End-Tidal Carbon Dioxide and Stroke Volume Variation Detected by Electrical Cardiometry as A Predictor of Fluid Volume Responsiveness in Hemodynamically Unstable Patients in the Intensive Care

February 19, 2021 updated by: Ahmed Elbaiomy Abo-elkhier, Tanta University
This study will be conducted to assess the role of end-tidal carbon dioxide (PETCO2) monitoring to predict the fluid volume responsiveness in correlation with stroke volume variation detected by electrical cardiometry in patients with hemodynamic instability.

Study Overview

Study Type

Observational

Enrollment (Actual)

60

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

    • ElGharbiaa
      • Tanta, ElGharbiaa, Egypt
        • Tanta University Hospitals

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Tanta University Hospital at surgical intensive care unit (SICU).

Description

Inclusion criteria:

  • Patients who will be 18 years or older.
  • Patients on mechanical ventilation in the intensive care.
  • Patients developing hypotension (MABP) <65 mmHg.

Exclusion Criteria:

  • Patients with organ/s failure at presentation.
  • Patients with deep venous thrombosis.
  • Patients with limb and pelvic fractures.
  • Pregnant patients

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
fluid responders

Moreover, since PETCO2 is mainly determined by tissue CO2 production (VCO2), alveolar ventilation and CO, when stable metabolic conditions are assumed and minute ventilation is kept constant, acute changes in PETCO2 have been shown to correlate strongly with changes in CO.

Thus, PETCO2 has been suggested as a simple economic and noninvasive alternative for continuous assessment of CO in different shock states.

fluid non responders

Moreover, since PETCO2 is mainly determined by tissue CO2 production (VCO2), alveolar ventilation and CO, when stable metabolic conditions are assumed and minute ventilation is kept constant, acute changes in PETCO2 have been shown to correlate strongly with changes in CO.

Thus, PETCO2 has been suggested as a simple economic and noninvasive alternative for continuous assessment of CO in different shock states.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of sensitivity and specificity of end tidal carbon dioxide monitoring in predicting fluid responsiveness in correlation with stoke volume variation detected by cardiometry
Time Frame: 24 hour
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 1, 2019

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

April 28, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 19, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 32880/01/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

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