AzTrials
AzTrials

HypotensionNCT04217226

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

An observational study of Hypotension and General Anesthesia Induced Hypotension, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 59 years
What is being tested?
Perfusion index derived parameters
Type of treatment
Medical device
How many people
93 participants
Where
1 siteEgypt
Study dates
20 Jan 2020to 28 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Adult

Study population: Participants will be adult patients (above 18 years), ASA I-II-III, scheduled for elective surgeries under general anaesthesia.

Who may be able to join

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

Who cannot join

  • • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Anesthesia Department

    Cairo

Other trials in Egypt

About this study

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

This study aims to evaluate the ability of preoperative plethysmographic variability index, perfusion index and the Dicrotic Plethysmography to predict post-induction hypotension.

Read the 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

Being tested
Perfusion index derived parameters
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perfusion index derived parametersDevice

    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 groups in NCT04217226
Study groupRoleWhat they receive
study groupadult patients (18-59 years), ASA I-II-III, scheduled for elective surgeries under general anaesthesia.
Receives: Device: Perfusion index derived parameters

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 10 minutes

Secondary outcomes (7)

  1. Mean arterial blood pressure

    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.

    Measured: 15 minutes

  2. Plethysmographic variability index

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

    Measured: 10 minutes

  3. Dicrotic Plethysmography

    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.

    Measured: 10 minutes

  4. Incidence of post-induction hypotension

    defined as mean arterial pressure < 75% of the baseline reading during the period from induction of anesthesia until skin incision.

    Measured: 15 minutes after induction of anesthesia

  5. Heart rate

    preoperative baseline readings

    Measured: 5 minutes

  6. systolic arterial blood pressure

    preoperative baseline readings

    Measured: 5 minutes

  7. diastolic arterial blood pressure

    preoperative baseline readings

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2020
  2. Study start20 Jan 2020
  3. Primary completion5 Jun 2020
  4. Study completion28 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04217226
Sponsor's protocol ID
MD-245-2019
Status last verified
Jul 2020
First submitted
2 Jan 2020
Last updated
30 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20236098

  • 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.

    PubMed 29307905

  • 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.

    PubMed 35359139

Questions about this trial

What is this clinical trial studying?

An observational study of Hypotension and General Anesthesia Induced Hypotension, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The area under receiver operating characteristic (AUROC) curve for perfusion index to predict hypotension after induction of anesthesia (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04217226, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in