Preoperative Ultrasound Guided Evaluation of SVC-CI and IVC -CI as Predictors of Hypotension After Induction of Anaesthesia in Major Onco-surgery (SVC IVC CI)

Preoperative Ultrasound Guided Evaluation of Subclavian Vein Collapsibility Index and Inferior Vena Cava Collapsibility Index as Predictors of Hypotension After Induction of General Anesthesia in Major Onco-surgery

Patients undergoing major Oncosurgeries are fluid deficit due to preoperative fasting , inadequate intake due to disease hence prone to development of hypotension after induction of general anaesthesia owing to vasodilatory effects of anesthetic induction agents. Investigators plan study to measure ultrasound guided Superior Vena Cava and Inferior Vena Cava collapsibility Index as predictors of hypotension after induction of General anaesthesia.

Study Overview

• Status: Completed
• Conditions: Total Fluid Volume Decreased
• Intervention / Treatment: Other: Ultrasound guided Superior Vena Cava Collapsibility Index; Other: Inferior Vena Cava Collapsibility Index

Detailed Description

Investigators plan prospective study , written informed will be taken from all included patients. In the OR 5 lead ECG, NIBP,SPO2 monitors will be attached , patients will be explained about Ultrasound imaging . Preinduction using SONOSITE EDGE II ultrasonography machine and placing high frequency linear array probe (6-13 Hz) beneath the middle of the clavicle aligned in deltopectoral groove to obtain short axis view of Subclavian/Infraclavicular axillary vein in B-Mode (2-D imaging). Doppler pulse waveform and minimum and maximum diameter measurements of SVC will be obtained in M-mode , both during spontaneous breathing and after deep inspiration, using digital calipers after freezing the image. The collapsibility index CI will be calculated using the following equation SCV AV CI = (dSCV max- dSCV min)/ dSCV max ×100.

A phased array or cardiac ultrasound probe (1-5Hz) will be placed in the subxiphoid window to view IVC at the junction of IVC with right atrium .Then the transducer will be adjusted to obtain the long axis view of IVC. Doppler pulse waveform will be obtained to ensure imaging of IVC and then in the M mode the minimum and maximum diameter measurements of IVC will be obtained both during spontaneous breathing and after deep inspiration, using digital calipers after freezing the image. The collapsibility index CI will calculated using the following equation:IVC CI = (dIVCmax- dIVCmin )/ dIVCmax ×100 . In all the patients both SVC and IVC -CI will be calculated.

All patients will receive standard General Anesthesia with IV Fentanyl 1-2 mcg/kg , Sleeping dose propofol , Atracurium 0.5mg/kg and orally placed Endotracheal tube.The heart rate (HR) and mean arterial pressure (MAP) will be recorded in two phases .Intraoperative hypotension (IOH) been defined as MAP<60mmHg or >30%decrease in MAP from baseline.

1. Post induction phase: Readings will be taken at 1 min intervals from the start of induction till intubation (upto 5 minutes) and
2. Post intubation phase: Readings will be taken at 2 min intervals upto 10 min and at 5 min intervals up to 30 mins or till incision . Each hypotensive episode encountered will be treated with leg lifting first (lifting both lower extremities for 2 minutes by technical staff) , if hypotension persists then IV Ephedrine 6 mg boluses will be given . All patients will receive preloading 200ml crystalloids prior to induction of anesthesia .

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110085
      • Rajiv Gandhi Cancer Institute And Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing major Onco-surgeries.

Description

Inclusion Criteria:

• Patients belonging to ASA Grade I,II,III
• For major Oncosurgery under general anaesthesia

Exclusion Criteria:

• Patient refusal
• BMI>30
• Emergency surgery
• Preoperative Hypotension MAP < 70 mmHg
• LVEF<40%
• Difficult Airway
• Nasal Intubation
• Inability to obtain good ultrasound images of SCV and IVC .

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ultrasound guided Superior Vena Cava Collapsibility Index (SVC - CI); Preoperative ultrasound guided Superior Vena Cava collapsibility Index will be measured with patient breathing spontaneously and on deep inspiration.	Other: Ultrasound guided Superior Vena Cava Collapsibility Index; Preoperative Ultrasound guided Superior Vena Cava Collapsibility Index will be measured
Ultrasound Guided Inferior Vena Cava Collapsibility Index (IVC -CI); Preoperative Ultrasound guided Inferior Vena Cava collapsibility Index will be measured with patient breathing spontaneously and on deep inspiration.	Other: Inferior Vena Cava Collapsibility Index; Preoperative Inferior Vena Cava Collapsibility Index will be measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare Subclavian Vein Collapsibility Index in percentage with Inferior Vena Cava Collapsibility Index in percentage as predictor of hypotension after induction of General anaesthesia	Preoperative Ultrasound guided Subclavian / Infraclavicular Axillary Vein Collapsibility Index and Inferior Vena Cava Collapsibility Index was measured with spontaneous breathing and on deep inspiration.	30 minutes prior to induction of anaesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the sensitivity of SVC -CI and IVC -CI as a predictor of hypotension after induction of General anesthesia .	Preoperative US Guided SVC-CI in percentage and IVC -CI in percentage values will be obtained and statistical analysis will be done	30 minutes prior to induction of anaesthesia

Collaborators and Investigators

• Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
• Investigators: Principal Investigator: Anita C Kulkarni, MD, Senior consultant

Publications and helpful links

General Publications

• Choi MH, Chae JS, Lee HJ, Woo JH. Pre-anaesthesia ultrasonography of the subclavian/infraclavicular axillary vein for predicting hypotension after inducing general anaesthesia: A prospective observational study. Eur J Anaesthesiol. 2020 Jun;37(6):474-481. doi: 10.1097/EJA.0000000000001192.
• Kaptein YE, Kaptein EM. Comparison of subclavian vein to inferior vena cava collapsibility by ultrasound in acute heart failure: A pilot study. Clin Cardiol. 2022 Jan;45(1):51-59. doi: 10.1002/clc.23758. Epub 2021 Dec 21.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2021
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: SCV IVC Collapsibility

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No