Clinical trial NCT03337386: Subclavian Versus Inferior Vena Cava Collapsibility Indices.
Official title: Reliability of Subclavian Vein Versus Inferior Vena Cava Collapsibility Indices for Preload Assessment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: inferior vena cava collapsibility index changes
timeFrame: 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 outcomes:
measure: subclavian vein collapsibility index changes
timeFrame: 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.
measure: central venous pressure changes
timeFrame: 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.
measure: heart rate changes
timeFrame: 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.
measure: mean blood pressure changes
timeFrame: 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.
measure: fluid administration
timeFrame: Intraoperative
measure: blood loss
timeFrame: intraoperative
measure: urine output
timeFrame: intraoperative
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Oncolgy Center, Mansoura University,
state: DK
Study officials:
References: