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Evaluation of Perfusion Index-derived Parameters as Predictors of Hypotension After Induction of General Anaesthesia

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ClinicalTrials.gov Identifier: NCT04217226
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Bassant M. Abdelhamid, 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.


Condition or disease Intervention/treatment
Hypotension General Anesthesia Induced Hypotension 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

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Study Type : Observational
Estimated Enrollment : 80 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 : January 20, 2020
Estimated Primary Completion Date : March 5, 2020
Estimated Study Completion Date : May 20, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
study group
adult patients (above 18 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 (from nadir point of the complex to the notch) to the height of the systolic peak (from the same nadir point of the complex to the peak), measured at end-expiratory time.





Primary Outcome Measures :
  1. The area under receiver operating characteristic (AUROC) curve for perfusion index to predict hypotension after induction of anesthesia [ Time Frame: 10 minutes after induction of anesthesia ]
    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 [ 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 the baseline preoperative reading until skin incision as follows: preinduction reading - 1-minute postinduction reading - 2-minute postinduction reading - preintubation reading - one-minute postintubation reading until skin incision).

  2. Heart rate [ Time Frame: 15 minutes ]
    measured at 1-minute intervals starting from the baseline preoperative reading until skin incision as follows: preinduction reading - 1-minute postinduction reading - 2-minute postinduction reading - preintubation reading - one-minute postintubation reading until skin incision

  3. Plethysmographic variability index [ Time Frame: 5 minutes ]
    PVI= [(PImax-PImin)/PImax] x100 PImax : maximum perfusion index PImin : minimum perfusion index PVI : plethysmographic variability index

  4. Dicrotic Plethysmography [ Time Frame: 5 minutes ]
    calculated as a ratio between height of the dicrotic notch (from nadir point of the complex to the notch) to amplitude of the pulsatile component of the digital photoplethysmographic signal(from the same nadir point of the complex to the peak it can also be described as the height of the systolic peak). The value will be obtained by averaging the values of three consecutive complexes, at end-expiratory time.

  5. Incidence of post-induction hypotension [ Time Frame: 15 minutes after induction of anesthesia ]
    defined as mean arterial pressure < 80% of the baseline reading during the period from induction of anesthesia until skin incision



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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.
Criteria

Inclusion Criteria:

  • • Adult patients (>18years)

    • ASA I-II-III
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217226


Contacts
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Contact: Bassant abdelhamid, M.D. 01224254012 bassantmohamed197@yahoo.com
Contact: Akram Yassin, MS 01095917195 Akram.yassin90@gmail.com

Locations
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Egypt
Anesthesia Department Recruiting
Cairo, Egypt
Contact: Hossam Alashmawy, M.D.    01001707493 ext 002    h.elashmawi@kasralainy.edu.eg   
Principal Investigator: bassant abdelhamid, MD         
Sub-Investigator: Akram Yassin, MS         
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Bassant abdelhamid, M.D. Cairo University
Publications:
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Responsible Party: Bassant M. Abdelhamid, associate professor, Cairo University
ClinicalTrials.gov Identifier: NCT04217226    
Other Study ID Numbers: S-245-2019 MD
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases