Subclavian Versus Inferior Vena Cava Collapsibility Indices.

Not Applicable

Completed

• Conditions: Hemodynamic Instability

• 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

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