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

NCT ID: NCT04217226

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-20

Study Completion Date

2020-07-28

Brief Summary

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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.

Detailed Description

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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

Conditions

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Hypotension General Anesthesia Induced Hypotension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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study group

adult patients (18-59 years), ASA I-II-III, scheduled for elective surgeries under general anaesthesia.

Perfusion index derived parameters

Intervention Type DEVICE

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.

Interventions

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Perfusion index derived parameters

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Bassant M. Abdelhamid

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bassant abdelhamid, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Anesthesia Department

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Tsuchiya 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.

Reference Type BACKGROUND
PMID: 20236098 (View on PubMed)

Mehandale SG, Rajasekhar P. Perfusion index as a predictor of hypotension following propofol induction - A prospective observational study. Indian J Anaesth. 2017 Dec;61(12):990-995. doi: 10.4103/ija.IJA_352_17.

Reference Type BACKGROUND
PMID: 29307905 (View on PubMed)

Abdelhamid B, Yassin A, Ahmed A, Amin S, Abougabal A. Perfusion index-derived parameters as predictors of hypotension after induction of general anaesthesia: a prospective cohort study. Anaesthesiol Intensive Ther. 2022;54(1):34-41. doi: 10.5114/ait.2022.113956.

Reference Type DERIVED
PMID: 35359139 (View on PubMed)

Other Identifiers

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MD-245-2019

Identifier Type: -

Identifier Source: org_study_id

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