Perfusion Index-derived Parameters as Predictors Post-induction Hypotension.

July 29, 2020 updated by: Bassant M. Abdelhamid, Cairo University

Evaluation of Perfusion Index-derived Parameters as Predictors of Hypotension After Induction of General Anaesthesia: a Prospective Cohort Study.

The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. PI represents the baseline sympathetic tone which is assumed one of the factors contributing for hypotension. Patients with low PI were reported by Mahendale and Rajasekhar to show greater hypotension after induction of anesthesia. This was explained by the high sympathetic tone in these patients which is suddenly masked by propofol administration leading to profound hypotension.

This study aims to evaluate the ability of preoperative plethysmographic variability index, perfusion index and the Dicrotic Plethysmography to predict post-induction hypotension.

Study Overview

Detailed Description

The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. PI represents the baseline sympathetic tone which is assumed one of the factors contributing for hypotension. Patients with low PI were reported by Mahendale and Rajasekhar to show greater hypotension after induction of anesthesia. This was explained by the high sympathetic tone in these patients which is suddenly masked by propofol administration leading to profound hypotension. Moreover, The PI has been described as a reliable tool for vascular tone assessment and monitoring.

Dicrotic Plethysmography (Dicpleth): is easily derived from the photoplethysmographic signal. It represents the relative height of the dicrotic wave compared with the maximum peak of the waveform, has been described as the amount of reflected wave, dependent on the vascular tone. M.Coutrot et al quantified Dicpleth variations to detect arterial hypotension and mentioned that Dicpleth and PI are both related to vascular tone and are easily derived from the photoplethysmographic signal. Moreover, Chowienczyk PJ et. al. demonstrated that the reduction in Dicpleth is related to the reduction of vascular tone caused by vasodilator drugs, such as salbutamol or glyceryl trinitrate

Study Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Anesthesia Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants will be adult patients (above 18 years), ASA I-II-III, scheduled for elective surgeries under general anaesthesia.

Description

Inclusion Criteria:

  • • Adult patients (18-59 years)

    • ASA I-II
    • 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 peripheral vascular disease or long standing DM affecting PVI readings.
    • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group
adult patients (18-59 years), ASA I-II-III, scheduled for elective surgeries under general anaesthesia.

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). This device allows bluetooth radio for transfer of parameter data to a smart device. The device will be applied on the index finger of the dominant hand of each patient. It will be applied on the hand that neither contains the venous line nor the blood pressure cuff. Three measurements of PVI and PI on one minute interval will be recorded. We will use the average of these readings.

Dicpleth is defined as the ratio of the height of the dicrotic notch to the height of the systolic peak, measured at end-expiratory time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The area under receiver operating characteristic (AUROC) curve for perfusion index to predict hypotension after induction of anesthesia
Time Frame: 10 minutes
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
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial blood pressure
Time Frame: 15 minutes
Mean arterial blood pressure will be measures in supine position in one of the upper limbs in the operating room measured at 1-minute intervals starting from preoperative baseline readings till skin incision.
15 minutes
Plethysmographic variability index
Time Frame: 10 minutes
The area under receiver operating characteristic (AUROC) curve for Plethysmographic variability index to predict hypotension after induction of anesthesia.
10 minutes
Dicrotic Plethysmography
Time Frame: 10 minutes

calculated as a ratio between height of the dicrotic notch to amplitude of the pulsatile component of the digital photoplethysmographic signal. The value will be obtained by averaging the values of three consecutive complexes, at end-expiratory time.

The area under receiver operating characteristic (AUROC) curve for Dicrotic Plethysmography to predict hypotension after induction of anesthesia.

10 minutes
Incidence of post-induction hypotension
Time Frame: 15 minutes after induction of anesthesia
defined as mean arterial pressure < 75% of the baseline reading during the period from induction of anesthesia until skin incision.
15 minutes after induction of anesthesia
Heart rate
Time Frame: 5 minutes
preoperative baseline readings
5 minutes
systolic arterial blood pressure
Time Frame: 5 minutes
preoperative baseline readings
5 minutes
diastolic arterial blood pressure
Time Frame: 5 minutes
preoperative baseline readings
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2020

Primary Completion (Actual)

June 5, 2020

Study Completion (Actual)

July 28, 2020

Study Registration Dates

First Submitted

January 2, 2020

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 3, 2020

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-245-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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