Subclavian Versus Inferior Vena Cava Collapsibility Indices.

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337386
• Other study ID #: MS/17.05.137
• Status: Completed
• Phase: N/A
• Start date: November 12, 2017
• Est. completion date: May 20, 2018

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 20, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• 1. American society of anaesthesiologists physical status grade I and grade II .

2. Elective laparotomy. 3. Supine position

Exclusion Criteria:

1. Patient refusal .

2. Portal hypertension .

3. Severe peripheral vascular diseases.

4. Obstructive lung diseases .

5. Right sided heart failure , arrhythmia and valvular heart heart diseases .

6. Body mass index >35 kg/m2

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Diagnostic Test:
• inferior vena cava collapsibility
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
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
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.

Locations

Country	Name	City	State
Egypt	Oncolgy Center, Mansoura University,	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inferior vena cava collapsibility index changes	ultrasound M mode maximum minus minimum over maximum then multiply by 100	intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after10 ml/kg ringers preload, 4th 5 minutes before extubation.
Secondary	subclavian vein collapsibility index changes	ultrasound M mode maximum minus minimum over the maximum then multiply by 100	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.
Secondary	central venous pressure changes	centimeter water	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.
Secondary	heart rate changes	beat per minute	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.
Secondary	mean blood pressure changes	millimeter mercury	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.
Secondary	fluid administration	milliliter	Intraoperative
Secondary	blood loss	milliliter	intraoperative
Secondary	urine output	milliliter	intraoperative