Subclavian Versus Inferior Vena Cava Collapsibility Indices.

Not Applicable

Completed

• Conditions: Hemodynamic Instability
• Interventions: Diagnostic Test: central venous pressure; Diagnostic Test: inferior vena cava collapsibility; Diagnostic Test: subclavian vein collapsibility

• Registration Number: NCT03337386
• Lead Sponsor: Mansoura University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-09
• Study Start: 2017-11-12
• Primary Completion: 2018-04-10
• Study Completion: 2018-05-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
central venous pressure	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.
Inferior Vena Cava Collapsibility	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	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.

Primary Outcome Measures

Name	Time	Method
inferior vena cava collapsibility index changes	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 Outcome Measures

Name	Time	Method
subclavian vein collapsibility index changes	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
fluid administration	Intraoperative	milliliter
blood loss	intraoperative	milliliter
central venous pressure changes	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
heart rate changes	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
mean blood pressure changes	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
urine output	intraoperative	milliliter

Trial Locations

Locations (1)

Oncolgy Center, Mansoura University,; 🇪🇬 Mansourah, DK, Egypt