Carotid Doppler and EEOT for Fluid Responsiveness Prediction

NCT04470856 | Completed DMC

• 1 other identifier: 1677
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Fluid responsiveness prediction prior to fluid challenge administration is a topic of interest, which has been extensively investigated, but remains challenging. In clinical practice, functional hemodynamic tests (FHT) consisting of maneuvers that affect cardiac function and/or heart-lung interaction, have been introduced in order to identify fluid responders and non-responders without fluid challenge administration. Changes in cardiac output induced by the Passive Leg Raising (PLR) test reliably predicted the increase in cardiac output to volume expansion. New approaches have been recently developed based on changes in respiratory dynamics, such as a transient increase in tidal volume, or a lung recruitment maneuver or an end-expiratory occlusion (EEO) test. The EEO leaded to an increase in venous return, cardiac preload and stroke volume in preload-responsive patients. The authors found that an increase in cardiac output ≥ 5% during a 15-s EEO reliably predicted its response to a 500-ml saline infusion. However, in order to identify the rapid and transient increase in cardiac index during the EEO, continuous and instantaneous cardiac output monitoring is necessary. Pulse contour analysis methods provide a beat-to-beat estimation of cardiac output and had been used in most of studies validating the EEO test. Carotid doppler is a non-invasive, bedside, easy to use ultrasound technique that measuring blood flow peak velocity (CDPV) and duration of systolic component of each cardiac cycle (from the onset to dicrotic notch- Flow time - FT) allows a reliable estimation of fluid status and could be an interesting alternative to track changes in SV and cardiac output.

Conditions

Septic Shock

Keywords

end-expiratory occlusion test; septic shock; carotid doppler

Outcome Measures

Primary Outcomes (1)

• Fluid responsiveness

  Evaluation of changes in systolic peak velocity (ΔV peak-CA) and in flow time (ΔFT) using carotid artery Doppler during an end-expiratory occlusion test and after fluid-challenge (500 ml)

  during EEOT

Study Arms (1)

septic shock patients

EXPERIMENTAL

Intubated patients with septic shock receive an end-expiratory occlusion test (EEOT) and, after the test, they receive a 500 ml-fluid challenge. During these phases the carotid doppler changes will be recorded.

Diagnostic Test: End-expiratory occlusion test (EEOT)

Interventions

End-expiratory occlusion test (EEOT) DIAGNOSTIC_TEST

An occlusion manoeuvre during the end of expiration for 20 seconds

septic shock patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• sedated and mechanically ventilated patients
• need a fluid challenge
• hypotension defined as a systolic arterial pressure ≤90 mmHg
• tachycardia ≥100 beats/min
• urinary flow ≤0.5 mL/kg/min for 2 hrs

You may not qualify if:

• age\< 18 y old
• significant valvular heart diseases
• cardiac arrhythmia
• peripheral arterial disease
• common carotid artery stenosis greater than 50%
• spontaneous breathing.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

Location

Related Publications (10)

• Pinsky MR. Functional hemodynamic monitoring. Crit Care Clin. 2015 Jan;31(1):89-111. doi: 10.1016/j.ccc.2014.08.005.

  PMID: 25435480 BACKGROUND

• Monnet X, Osman D, Ridel C, Lamia B, Richard C, Teboul JL. Predicting volume responsiveness by using the end-expiratory occlusion in mechanically ventilated intensive care unit patients. Crit Care Med. 2009 Mar;37(3):951-6. doi: 10.1097/CCM.0b013e3181968fe1.

  PMID: 19237902 BACKGROUND

• Myatra SN, Prabu NR, Divatia JV, Monnet X, Kulkarni AP, Teboul JL. The Changes in Pulse Pressure Variation or Stroke Volume Variation After a "Tidal Volume Challenge" Reliably Predict Fluid Responsiveness During Low Tidal Volume Ventilation. Crit Care Med. 2017 Mar;45(3):415-421. doi: 10.1097/CCM.0000000000002183.

  PMID: 27922879 BACKGROUND

• Blehar DJ, Glazier S, Gaspari RJ. Correlation of corrected flow time in the carotid artery with changes in intravascular volume status. J Crit Care. 2014 Aug;29(4):486-8. doi: 10.1016/j.jcrc.2014.03.025. Epub 2014 Apr 2.

  PMID: 24930363 BACKGROUND

• Mackenzie DC, Khan NA, Blehar D, Glazier S, Chang Y, Stowell CP, Noble VE, Liteplo AS. Carotid Flow Time Changes With Volume Status in Acute Blood Loss. Ann Emerg Med. 2015 Sep;66(3):277-282.e1. doi: 10.1016/j.annemergmed.2015.04.014. Epub 2015 May 21.

  PMID: 26003002 BACKGROUND

• Hossein-Nejad H, Mohammadinejad P, Lessan-Pezeshki M, Davarani SS, Banaie M. Carotid artery corrected flow time measurement via bedside ultrasonography in monitoring volume status. J Crit Care. 2015 Dec;30(6):1199-203. doi: 10.1016/j.jcrc.2015.08.014. Epub 2015 Aug 22.

  PMID: 26410681 BACKGROUND

• Shokoohi H, Berry GW, Shahkolahi M, King J, King J, Salimian M, Poshtmashad A, Pourmand A. The diagnostic utility of sonographic carotid flow time in determining volume responsiveness. J Crit Care. 2017 Apr;38:231-235. doi: 10.1016/j.jcrc.2016.10.025. Epub 2016 Nov 9.

  PMID: 27987483 BACKGROUND

• 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.

  PMID: 26123610 BACKGROUND

• Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.

  PMID: 25392034 RESULT

• D'Arrigo S, Dell'Anna AM, Sandroni C, Messina A, Cacciola S, Pacini C, Antonelli M. Can carotid artery Doppler variations induced by the end-expiratory occlusion maneuver predict fluid responsiveness in septic shock patients? Crit Care. 2023 Apr 19;27(1):153. doi: 10.1186/s13054-023-04422-9.

  PMID: 37076861 DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Participants receive an 20sec-EEOT at the initial phase of the study, then they receive a fluid challenge during the second phase of the study

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 14, 2020
• Study Start: January 1, 2019
• Primary Completion: July 30, 2020
• Study Completion: December 31, 2020
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)