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NCT Number: NCT03337386

Subclavian Versus Inferior Vena Cava Collapsibility Indices.

Traditional methods for intravascular volume status assessment include physical examination, raised leg test, central venous pressure (CVP) and pulmonary artery catheters occlusion pressure (PAWP). Central venous pressure and pulmonary artery occlusion pressure are invasive and associated with significant complications. More recently, a number of less invasive techniques have been introduced, but they lack standardization and reliability. Ultrasonically, inferior vena cava collapsibility can detect hypovolemia non-invasively.

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Key information

Conditions

Hemodynamic Instability

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oncolgy Center, Mansoura University,

Al Mansurah, DK, Egypt

About this study

The aim of this study is that measurement of subclavian vein collapsibility index(SCV-CI) could be potential adjunct to IVC-CI where the IVC visualization is impaired or not possible .

-Finding a non-invasive reliable accurate method for evaluation of intravascular volume and response to volume resuscitation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. American society of anaesthesiologists physical status grade I and grade II .
  • Elective laparotomy. 3. Supine position

Exclusion criteria

  • Patient refusal .
  • Portal hypertension .
  • Severe peripheral vascular diseases.
  • Obstructive lung diseases .
  • Right sided heart failure , arrhythmia and valvular heart heart diseases .
  • Body mass index >35 kg/m2

Treatment and study plan

inferior vena cava collapsibility

Diagnostic Test

inferior vena cava diameters is obtained in the supine position with a convex probe .The probe is placed in the subxiphoid region or the right anterior midaxillary plane.The sagittal section of IVC is imaged. M-mode probe is used to identify the measurement of minimum and maximum venous dimensions over the respiratory cycle using the 3.5-5 MHz phased array probe. To standardize the measurements, measuring of the IVC diameter is performed at 2 cm caudal of the junction point of the right atrium and IVC. The difference between the maximum (D max) and minimum (D min)diameters of the target vein is normalized according to the standard formula to yield the collapsibility index (CI).

subclavian vein collapsibility

Diagnostic Test

Right SCV diameters is checked in the supine position using a high frequency linear array probe (6-13 MHz) and M-mode. To standardize the measurements, the probe is placed beneath the proximal part of the middle part of the clavicle perpendicular to long-axis of the SCV to obtain the best cross-sectional view of the vien. After the target vein is localized , the dynamic diameter change is recorded using M-mode to identify and measure the minimum and maximum venous diameters.To calculate SCV collapsibility index, the standard formula is used.

central venous pressure

Diagnostic Test

ultrasound guided 7.5-F central venous catheter is introduced via right internal jugular vein under local analgesia with 2% lidocaine for measuring the CVP.

Primary outcomes

  1. inferior vena cava collapsibility index changes

    Time frame: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after10 ml/kg ringers preload, 4th 5 minutes before extubation.

    ultrasound M mode maximum minus minimum over maximum then multiply by 100

Secondary outcomes

  1. subclavian vein collapsibility index changes

    Time frame: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after 10 ml/kg ringers preload, 4th 5 minutes before extubation.

    ultrasound M mode maximum minus minimum over the maximum then multiply by 100

  2. central venous pressure changes

    Time frame: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after 10 ml/kg ringers preload, 4th 5 minutes before extubation.

    centimeter water

  3. heart rate changes

    Time frame: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after 10 ml/kg ringers preload, 4th 5 minutes before extubation.

    beat per minute

  4. mean blood pressure changes

    Time frame: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after 10 ml/kg ringers preload, 4th 5 minutes before extubation.

    millimeter mercury

  5. fluid administration

    Time frame: Intraoperative

    milliliter

  6. blood loss

    Time frame: intraoperative

    milliliter

  7. urine output

    Time frame: intraoperative

    milliliter

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Reliability of Subclavian Vein Versus Inferior Vena Cava Collapsibility Indices for Preload Assessment.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 9, 2017
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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