Subclavian Versus Inferior Vena Cava Collapsibility Indices.

NCT03337386 | Completed

• 1 other identifier: MS/17.05.137
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• fluid administration

  Intraoperative

Study Arms (3)

Inferior Vena Cava Collapsibility

EXPERIMENTAL

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).

Diagnostic Test: inferior vena cava collapsibility

Subclavian Vein Collapsibility

EXPERIMENTAL

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.

Diagnostic Test: subclavian vein collapsibility

central venous pressure

ACTIVE COMPARATOR

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.

Diagnostic Test: central venous pressure

Interventions

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).

Inferior Vena Cava Collapsibility

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.

Subclavian Vein Collapsibility

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.

central venous pressure

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Oncolgy Center, Mansoura University,

Al Mansurah, DK, Egypt

Location

MeSH Terms

Interventions

Central Venous Pressure

Intervention Hierarchy (Ancestors)

Venous Pressure; Blood Pressure; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 9, 2017
• Study Start: November 12, 2017
• Primary Completion: April 10, 2018
• Study Completion: May 20, 2018
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

EG (1)