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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04217226
Collaborator
(none)
93
1
6.2
14.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Perfusion index derived parameters

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 Design

Study Type:
Observational
Actual Enrollment :
93 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Perfusion Index-derived Parameters as Predictors of Hypotension After Induction of General Anaesthesia: a Prospective Cohort Study.
Actual Study Start Date :
Jan 20, 2020
Actual Primary Completion Date :
Jun 5, 2020
Actual Study Completion Date :
Jul 28, 2020

Arms and Interventions

Arm Intervention/Treatment
study group

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

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Plethysmographic variability index [10 minutes]

    The area under receiver operating characteristic (AUROC) curve for Plethysmographic variability index to predict hypotension after induction of anesthesia.

  3. 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.

  4. 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.

  5. Heart rate [5 minutes]

    preoperative baseline readings

  6. systolic arterial blood pressure [5 minutes]

    preoperative baseline readings

  7. diastolic arterial blood pressure [5 minutes]

    preoperative baseline readings

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anesthesia Department Cairo Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Bassant abdelhamid, M.D., Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bassant M. Abdelhamid, associate professor, Cairo University
ClinicalTrials.gov Identifier:
NCT04217226
Other Study ID Numbers:
  • MD-245-2019
First Posted:
Jan 3, 2020
Last Update Posted:
Jul 30, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 30, 2020