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

Completed

• Conditions: Hypotension; General Anesthesia Induced Hypotension
• Interventions: Device: Perfusion index derived parameters

• Registration Number: NCT04217226
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-03
• Study Start: 2020-01-20
• Primary Completion: 2020-06-05
• Status Verified: 2020-07
• Study Completion: 2020-07-28
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	Perfusion index derived parameters	adult patients (18-59 years), ASA I-II-III, scheduled for elective surgeries under general anaesthesia.

Primary Outcome Measures

Name	Time	Method
The area under receiver operating characteristic (AUROC) curve for perfusion index to predict hypotension after induction of anesthesia	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

Secondary Outcome Measures

Name	Time	Method
diastolic arterial blood pressure	5 minutes	preoperative baseline readings
Heart rate	5 minutes	preoperative baseline readings
Mean arterial blood pressure	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.
Dicrotic Plethysmography	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.
systolic arterial blood pressure	5 minutes	preoperative baseline readings
Incidence of post-induction hypotension	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.
Plethysmographic variability index	10 minutes	The area under receiver operating characteristic (AUROC) curve for Plethysmographic variability index to predict hypotension after induction of anesthesia.

Trial Locations

Locations (1)

Anesthesia Department; 🇪🇬 Cairo, Egypt