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出境医 / 临床实验 / 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

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

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
End Tidal Carbon Dioxide Cardiometry Fluid Responsiveness Shock Device: end tidal carbon dioxide by capnography

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : January 1, 2021
Actual Study Completion Date : January 31, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
fluid responders Device: end tidal carbon dioxide by capnography

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 Device: end tidal carbon dioxide by capnography

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.
Outcome Measures
Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Tanta University Hospital at surgical intensive care unit (SICU).
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Egypt
Tanta University Hospitals
Tanta, ElGharbiaa, Egypt
Sponsors and Collaborators
Tanta University
Tracking Information
First Submitted Date April 28, 2019
First Posted Date May 1, 2019
Last Update Posted Date February 21, 2021
Actual Study Start Date June 1, 2019
Actual Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2019) 		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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title 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
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Tanta University Hospital at surgical intensive care unit (SICU).
Condition
  • End Tidal Carbon Dioxide
  • Cardiometry
  • Fluid Responsiveness
  • Shock
Intervention Device: end tidal carbon dioxide by capnography

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.
Study Groups/Cohorts
  • fluid responders
    Intervention: Device: end tidal carbon dioxide by capnography
  • fluid non responders
    Intervention: Device: end tidal carbon dioxide by capnography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 29, 2019) 		60
Original Estimated Enrollment Same as current
Actual Study Completion Date January 31, 2021
Actual Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03932617
Other Study ID Numbers 32880/01/19
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Responsible Party Ahmed Elbaiomy Abo-elkhier, Tanta University
Study Sponsor Tanta University
Collaborators Not Provided
Investigators Not Provided
PRS Account Tanta University
Verification Date February 2021

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