IVC Ultrasonography Versus Plethysmographic Variability Index for Prediction of General Anesthesia Induction Hypotension
Comparison of Ultrasound-based Measures of Inferior Vena Cava and Plethysmographic Variability Index for Prediction of Hypotension During Induction of General Anesthesia; Prospective Cohort Study.
1 other identifier
observational
90
1 country
2
Brief Summary
This thesis aims to evaluate the ability of preoperative plethysmographic variability index to predict post-induction hypotension in comparison with ultrasound measurements of inferior vena cava (IVC) diameter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2021
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2020
CompletedFirst Posted
Study publicly available on registry
January 23, 2020
CompletedStudy Start
First participant enrolled
August 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedOctober 6, 2021
October 1, 2021
3 months
January 20, 2020
October 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of the accuracy (Area under receiver operating characteristic curves) of PVI and IVC variation in prediction of post-induction hypotension
Maximum and minimum IVC diameters over a single respiratory cycle will be measured using a built-in software. The CI will be calculated as: CI = (dIVCmax - dIVCmin)/dIVCmax CI will be expressed as a percentage
10 minutes before general anesthesia
Secondary Outcomes (4)
Plethysmographic variability index (PVI) and a perfusion index readings (PI)
3 minutes
Maximum and minimum IVC diameters
10 minutes
Mean arterial blood pressure
20 minutes
Heart rate
20 minutes
Study Arms (1)
study group
Participants will be adult patients (above 18 years), ASA I-II-III, scheduled for elective surgeries under general anesthesia.
Interventions
Ultrasound measurements will be performed using a curved transducer set to abdominal mode (1-5 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea). IVC variation will be assessed using ultrasound in the long-axis (sagittal) view. IVC diameter will be measured 1 cm distal to its junction with hepatic vein either by 2-D or M modes via a subcostal approach according to the methodology described by the American Society of Echocardiography . A two-dimensional image of the IVC as it enters the right atrium will be first obtained.
The PVI and PI will be recorded in the supine position by an anaesthesiologist who was not involved in the further intraoperative monitoring of the patient using Masimo SET ("MightySat 9900, Masimo Corporation, Irvine, CA, USA). PVI (%) is a measure of the dynamic change in PI that occurs during one or more complete respiratory cycles, calculated as: PVI= \[(PImax-PImin)/PImax\] x100
Eligibility Criteria
Participants will be adult patients (above 18 years), ASA I-II-III, scheduled for elective surgeries under general anaesthesia.
You may qualify if:
- Adult patients (\>18years)
- ASA I-II-III
- Patients scheduled for elective surgeries under general anaesthesia.
You may not qualify if:
- Operations which will last for less than 15 minutes.
- Patients with cardiac morbidities (impaired contractility with ejection fraction \< 40% and tight valvular lesions, unstable angina).
- Patients with heart block and arrhythmia (atrial fibrillation and frequent ventricular or supraventricular premature beat).
- Patient with decompansted respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation \< 90% on room air).
- Patients with increased intraabdominal pressure (intrabdominal mass compressing IVC).
- Patients with peripheral vascular disease or long standing DM affecting PVI readings.
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (2)
Kasr alainy
Cairo, 1772, Egypt
Almaza Militrary Hospital
Cairo, Egypt
Related Publications (3)
Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
PMID: 30236233BACKGROUNDZhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.
PMID: 26771910BACKGROUNDTsuchiya M, Yamada T, Asada A. Pleth variability index predicts hypotension during anesthesia induction. Acta Anaesthesiol Scand. 2010 May;54(5):596-602. doi: 10.1111/j.1399-6576.2010.02225.x. Epub 2010 Mar 10.
PMID: 20236098BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Bassant abdelhamid, M.D.
Cairo University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
January 20, 2020
First Posted
January 23, 2020
Study Start
August 5, 2021
Primary Completion
October 30, 2021
Study Completion
November 1, 2021
Last Updated
October 6, 2021
Record last verified: 2021-10