NCT05548920

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

September 14, 2022

Last Update Submit

January 17, 2023

Conditions

Total Fluid Volume Decreased

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To evaluate the sensitivity of SVC -CI and IVC -CI as a predictor of hypotension after induction of General anesthesia .

    30 minutes prior to induction of anaesthesia

Study Arms (2)

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

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

Interventions

Ultrasound guided Superior Vena Cava Collapsibility IndexOTHER

Preoperative Ultrasound guided Superior Vena Cava Collapsibility Index will be measured

Ultrasound guided Superior Vena Cava Collapsibility Index (SVC - CI)
Inferior Vena Cava Collapsibility IndexOTHER

Preoperative Inferior Vena Cava Collapsibility Index will be measured.

Ultrasound Guided Inferior Vena Cava Collapsibility Index (IVC -CI)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing major Onco-surgeries.

You may qualify if:

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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajiv Gandhi Cancer Institute and Research Centre

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Related Publications (2)

  • 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.

    PMID: 32205573RESULT

  • 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.

    PMID: 34931333RESULT

Study Officials

  • Anita C Kulkarni, MD

    Senior Consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 22, 2022

Study Start

June 26, 2021

Primary Completion

December 30, 2022

Study Completion

January 10, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)