Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness
- Conditions
- Hemodynamic Instability
- Registration Number
- NCT05185141
- Lead Sponsor
- Johannes Gutenberg University Mainz
- Brief Summary
The purpose of this study is to assess respiratory variation of carotid doppler peak velocity (∆CDPV) for prediction of fluid responsiveness during major abdominal surgery.
- Detailed Description
Investigating hemodynamic parameters in a group of 19 ICU-patients with septic shock, respiratory variation of carotid doppler peak velocity (∆CDPV) has been shown to be able to predict fluid responsiveness. For patients receiving so called lung protective ventilation with a tidal volume of 6ml/kg ∆CDPV was superior for prediction of fluid responsiveness when compared to other well established parameters such as pulse pressure variation (∆PP).
Likewise in another study ∆CDPV has been shown to be superior to stroke volume variation (∆SV) for prediction of fluid responsiveness in patients with septic shock when ventilated with a tidal volume of ≥8ml/ kg.
All in all respiratory variation of carotid doppler peak velocity (∆CDPV) seems to be a promising parameter for prediction of fluid responsiveness (Yao et al., BMC Anesthesiology 2018). However, so far clinical studies have been conducted only under a small number of patients mainly in the intensive care unit and/ or under highly specific conditions (e.g. cardiac surgery).
If ∆CDPV is able to predict fluid responsiveness with high accuracy intraoperatively remains unknown. The investigators are therefore conducting this prospective monocentric observational trial to evaluate the performance of ∆CDPV during major abdominal surgery and compare it to validated fluid responsiveness monitoring parameters ∆PP and corrected flow time (fTc).
Following IRB-approval and written informed consent 84 patients scheduled for major abdominal surgery will be enrolled in the study. Stroke volume will be monitored by Esophageal Doppler Monitoring (CardioQ-ODM®, Deltex Medical Ltd, Chichester, UK). In case of hypovolemia a fluid bolus of 7 ml/kg ideal body weight will be administered at the discretion of the attending anesthesiologist. Respiratory variation of carotid doppler peak velocity (∆CDPV) will be monitored before and 1 minute after completion of each fluid bolus using an ultrasound device with a common linear array transducer (Philips ClearVue 350, Philips Medizin Systeme GmbH, Boeblingen, Germany).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- Age 18-80 years
- written informed consent
- scheduled major abdominal surgery
- Age <18 or >80 years
- pregnancy
- SIRS or sepsis
- any kind of cardiac arrhythmia
- known valve disease
- known heart failure
- any kind of known carotid stenosis
- carotid doppler peak velocity >182 cm/s before baseline measurement (expected stenosis)
- missing indication for invasive arterial blood pressure monitoring (IBP) not related to the study
- peripheral artery disease (PAD)
- BMI > 35 kg/m2
- intraabdominal hypertension
- ASA-PSC of 4
- severe lung disease (e.g. COPD grade 3, fibrosis)
- esophageal disease of any kind
- participation in another clinical study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in stroke volume following a fluid bolus. Immediately before and 1 minute after completion of each fluid bolus. A rise in stroke volume of ≥10% following a fluid bolus of 7ml/kg Ideal Body Weight is considered to reflect fluid responsiveness. Measurements will be assessed through esophageal doppler monitoring.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Anesthesiology, Johannes-Gutenberg University Medical Center
🇩🇪Mainz, Rhineland-Palatinate, Germany