Clinical Trials Directory

Trials / Unknown

UnknownNCT04238234

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
Phase
Study type
Observational
Enrollment
90 (estimated)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
DEVICEIVC UltrasonographyUltrasound 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

Timeline

Start date
2021-08-05
Primary completion
2021-10-30
Completion
2021-11-01
First posted
2020-01-23
Last updated
2021-10-06

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04238234. Inclusion in this directory is not an endorsement.