The Ratio Of Femoral Vein Diameter To Femoral Artery Diameter With Pulse Pressure Variation As A Diagnostic Tool

NCT05588180 | Completed

• 1 other identifier: M 600
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In assessing critically ill patients, an accurate assessment of a patient's volume status and whether they will respond to a fluid challenge with an increase in cardiac output is vital. 1 When hypovolemia is detected, volume expansion is utilized to enhance hemodynamics and restore normal blood pressure. 2 Hemodynamic tests (right atrial pressure, pulmonary artery occlusion pressure, and cardiac output ) are used to assess preload in critically ill patients, although these indexes are not necessarily reliable predictors of fluid status. According to the Starling law, fluid administration is hypothesized to boost cardiac output by raising preload, which describes a positive relationship between cardiac muscle fiber length and contractility. However, the Starling curve hits a plateau beyond its ascending leg, and additional fluid administration can be hazardous, leading to right ventricular overload and pulmonary edema Invasive or noninvasive techniques can be used to determine blood volume status. Assessments such as central venous pressure (CVP) and mean pulmonary artery pressure (mPAP) are both invasive procedures. Various factors influence CVP (including thoracic, pericardial, abdominal pressures, etc.). CVP can be used as a fluid management indication, although It can be misused to estimate blood volume or mislead methods for treatment. Dynamic indices such as stroke volume variation (SVV) and pulse pressure variation (PPV) are superior to static indices for assessing volume status. However, these dynamic indices are unreliable when a patient is ventilated with low tidal volume, such as acute respiratory distress syndrome (ARDS); the tidal volume is insufficient to change intrathoracic pressure significantly. Ultrasound (US) evaluation of the inferior vena cava (IVC) may help determine fluid status.

Conditions

Mechanically Ventilated Patients

Keywords

mechanically ventilated patients; FVD / FAD

Outcome Measures

Primary Outcomes (1)

• MAP

  mean arterial blood pressure

  the first 48 hours postoperative

Secondary Outcomes (2)

• the cutoff value of FVD/FAD reflecting FR

  the first 48 hours postoperative

• PPV

  the first 48 hours postoperative

Study Arms (2)

Group (P)

ACTIVE COMPARATOR

Group (P) PPV guided group

Procedure: PPV

Group (F)

ACTIVE COMPARATOR

Group (F) FVD/FAD ratio guided

Procedure: FVD/FAD ratio guided

Interventions

FVD/FAD ratio guided PROCEDURE

Ultrasound-guided ratio

Group (F)

PPV PROCEDURE

PPV

Group (P)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients on mechanical ventilation

You may not qualify if:

• cardiac arrhythmias
• previously known significant valvular disease or intracardiac shunt
• air leakage through chest drains
• increasing intraabdominal pressure
• norepinephrine infusion as it decreases PPV and SVV
• peripheral vascular diseases
• ARDS

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location

Related Publications (2)

• Kalantari K, Chang JN, Ronco C, Rosner MH. Assessment of intravascular volume status and volume responsiveness in critically ill patients. Kidney Int. 2013 Jun;83(6):1017-28. doi: 10.1038/ki.2012.424. Epub 2013 Jan 9.

  PMID: 23302716 RESULT

• Monnet X, Marik PE, Teboul JL. Prediction of fluid responsiveness: an update. Ann Intensive Care. 2016 Dec;6(1):111. doi: 10.1186/s13613-016-0216-7. Epub 2016 Nov 17.

  PMID: 27858374 RESULT

Study Officials

• Mohamed Hamed, M D

  Fayoum University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR OF ANESTHESIA

Model Details: group (F) FVD/FAD ratio guided

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 20, 2022
• Study Start: October 18, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 20, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)