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

NCT04217226 | Completed

• 1 other identifier: MD-245-2019
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; General Anesthesia Induced Hypotension

Outcome Measures

Primary Outcomes (1)

• The area under receiver operating characteristic (AUROC) curve for perfusion index to predict hypotension 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

  10 minutes

Secondary Outcomes (7)

• Mean arterial blood pressure

  15 minutes

• Plethysmographic variability index

  10 minutes

• Dicrotic Plethysmography

  10 minutes

• Incidence of post-induction hypotension

  15 minutes after induction of anesthesia

• Heart rate

  5 minutes

Study Arms (1)

study group

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

Device: Perfusion index derived parameters

Interventions

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.

study group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Adult patients (18-59 years)
• ASA I-II
• Patients scheduled for elective surgeries under general anaesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Anesthesia Department

Cairo, Egypt

Location

Related Publications (3)

• 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.

  PMID: 20236098 BACKGROUND

• 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.

  PMID: 29307905 BACKGROUND

• 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.

  PMID: 35359139 DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bassant abdelhamid, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 3, 2020
• Study Start: January 20, 2020
• Primary Completion: June 5, 2020
• Study Completion: July 28, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

EG (1)