Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness

Sponsor

Johannes Gutenberg University Mainz (Other)

Overall Status

Recruiting

CT.gov ID

NCT05185141

Collaborator

(none)

Enrollment

Location

18.6

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

84 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessing Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness During Abdominal Surgery: a Prospective Observational Trial

Actual Study Start Date :

Jan 11, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-80 years
written informed consent
scheduled major abdominal surgery

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology, Johannes-Gutenberg University Medical Center	Mainz	Rhineland-Palatinate	Germany	55131

Sponsors and Collaborators

Johannes Gutenberg University Mainz

Investigators

Study Chair: Gunther J Pestel, M.D., Ph.D., Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology
Study Director: Kimiko Fukui-Dunkel, M.D., Ph.D., Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology