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Completed

NCT Number: NCT04217226

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

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases General Anesthesia Induced Hypotension Vascular Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Anesthesia Department

Cairo, Egypt

About this 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. 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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perfusion index derived parameters

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Heart rate

    Time frame: 5 minutes

    preoperative baseline readings

  6. systolic arterial blood pressure

    Time frame: 5 minutes

    preoperative baseline readings

  7. diastolic arterial blood pressure

    Time frame: 5 minutes

    preoperative baseline readings

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 3, 2020
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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