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

Hemodynamic Instability Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05185141
• Other study ID #: 21-02546
• Status: Recruiting
• Start date: January 11, 2022
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Johannes Gutenberg University Mainz
• Contact: Johannes M Wirkus, M.D.
• Phone: 0049 6131 17- 7175
• Email: johannes.wirkus[@]unimedizin-mainz.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, Johannes-Gutenberg University Medical Center	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Ibarra-Estrada MA, Lopez-Pulgarin JA, Mijangos-Mendez JC, Diaz-Gomez JL, Aguirre-Avalos G. Respiratory variation in carotid peak systolic velocity predicts volume responsiveness in mechanically ventilated patients with septic shock: a prospective cohort study. Crit Ultrasound J. 2015 Dec;7(1):29. doi: 10.1186/s13089-015-0029-1. Epub 2015 Jun 26. — View Citation

Lu N, Xi X, Jiang L, Yang D, Yin K. Exploring the best predictors of fluid responsiveness in patients with septic shock. Am J Emerg Med. 2017 Sep;35(9):1258-1261. doi: 10.1016/j.ajem.2017.03.052. Epub 2017 Mar 22. — View Citation

Yao B, Liu JY, Sun YB. Respiratory variation in peripheral arterial blood flow peak velocity to predict fluid responsiveness in mechanically ventilated patients: a systematic review and meta-analysis. BMC Anesthesiol. 2018 Nov 13;18(1):168. doi: 10.1186/s12871-018-0635-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in stroke volume following a 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.	Immediately before and 1 minute after completion of each fluid bolus.