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Clinical Trials/NCT03139929
NCT03139929
Unknown
Not Applicable

Measurement of Mean Systemic Filling Pressure & Stressed Volume With CardioQ+® Oesophageal Doppler Measurement

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country42 target enrollmentMay 9, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
42
Locations
1
Primary Endpoint
MSFPhold
Last Updated
6 years ago

Overview

Brief Summary

To study the reliablity of MSFP and stressed volume to follow volume loading and to predict fload loading responsiveness in patients after elective coronary artery bypass grafting (CABG) surgery.

Detailed Description

In this study the oesophageal Doppler monitor (CardioQ+), arterial pulse wave analysis (via the CardioQ+ and Flotrac device) and central venous pressure (CVP) will be used to estimate mean systemic filling pressure (MSFP) with the inspiratory hold method. Furthermore the MSFParm will be determined using a rapid cuff inflator. From MSFP vascular compliance (Csys) and stressed volume (Vs) will be calculated. The accuracy of Vs to follow a 500 increase in volume will be studied. The accuracy of MSFP and Vs to to predict fluid loading responsiveness will be assessed in 42 patients after elective coronary artery bypass grafting (CABG) surgery. The effect of a standardised fluid loading on parameters of intrinsic contractility and afterload will be determined. The effect of fluid loading on inertia, resistance and elastance will be assessed

Registry
clinicaltrials.gov
Start Date
May 9, 2017
End Date
March 1, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

D.P.Veelo

MD PhD

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility Criteria

Inclusion Criteria

  • Patients 18 years and older planned for CABG

Exclusion Criteria

  • Contraindication for fluid loading
  • Pregnancy, morbid obesity
  • Hemodynamic instability with a mean arterial pressure (MAP) \< 55 mm Hg and/ or a cardiac index \< 1.5 L•min-1
  • Severe arrhythmias
  • Intra-cardiac shunts
  • Symptomatic peripheral vascular disease
  • Symptomatic pulmonary disease
  • Significant valvular regurgitation
  • Poor pre-operative left or right ventricular function
  • Core temperature \< 36 °C

Outcomes

Primary Outcomes

MSFPhold

Time Frame: Before and after fluid administration (2 minutes and 10 minutes)

Mean systemic filling pressure

MSFParm

Time Frame: Before and after fluid administration (2 minutes and 10 minutes)

Mean systemic filling pressure

Secondary Outcomes

  • Stressed volume(Before and after fluid administration (2 minutes and 10 minutes))

Study Sites (1)

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