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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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04238234
Enrollment
90
Registered
2020-01-23
Start date
2021-08-05
Completion date
2021-11-01
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension on Induction

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.

Detailed description

Prospective cohort study. Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied, intravenous line will be secured and routine premedications (ranitidine 50 mg and ondansteron 4mg) will be administrated. Then inferior vena cava ultrasonography will be performed. Maximum and minimum IVC diameters over a single respiratory cycle will be measured using built-in software. The CI will be calculated as: CI = (dIVCmax - dIVCmin)/dIVCmax , it will be expressed as a percentage. Plethysmographic variability index and a perfusion index readings will be taken preinduction in the form of three readings on one-minute interval. Induction of anaesthesia will be achieved using propofol (2 mg/Kg) and atracurium (0.5 mg/Kg). Endotracheal tube will be inserted after 3 minutes of mask ventilation. Anaesthesia will be maintained by isoflurane (1-1.5%) and atracurium 10 mg increments every 20 minutes. Ringer lactate solution will be infused at a rate of 2 mL/Kg/hour. Any episode of hypotension (defined as mean arterial pressure \< 80% of the baseline reading) will be managed by 5mcg norepinephrine.

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.

DEVICEPlethysmographic variability index (PVI) and perfusion index readings (PI)

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

Inclusion criteria

* Adult patients (\>18years) * ASA I-II-III * Patients scheduled for elective surgeries under general anaesthesia.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the accuracy (Area under receiver operating characteristic curves) of PVI and IVC variation in prediction of post-induction hypotension10 minutes before general anesthesiaMaximum 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

Secondary

MeasureTime frameDescription
Plethysmographic variability index (PVI) and a perfusion index readings (PI)3 minutesThree readings, on one-minute interval before general anesthesia induction
Maximum and minimum IVC diameters10 minutesMaximum and minimum IVC diameters over a single respiratory cycle will be measured using built-in software. The CI will be calculated as: CI = (dIVCmax - dIVCmin)/dIVCmax , it will be expressed as a percentage.
Mean arterial blood pressure20 minutesmeasured at 1-minute intervals starting from the baseline preoperative reading until skin incision as follows: preinduction reading - 1-minute postinduction reading - 2-minute postinduction reading - preintubation reading - one-minute postintubation reading until skin incision
Heart rate20 minutesmeasured at 1-minute intervals starting from the baseline preoperative reading until skin incision as follows: preinduction reading - 1-minute postinduction reading - 2-minute postinduction reading - preintubation reading - one-minute postintubation reading until skin incision

Countries

Egypt

Contacts

Primary ContactBassant abdelhamid, M.D.
bassantmohamed197@yahoo.com01224254012
Backup ContactAkram Yassin, MS
Akram.yassin90@gmail.com010 95 91 71 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026