Early Detection of Intra Operative Hypotension (IOH) During the Induction of General Anaesthesia

November 27, 2018 updated by: Joaquim MATEO, Hopital Lariboisière

Non-invasive and Continuous Detection of Arterial Hypotension Using Photoplethysmographic Signal During Induction of Anaesthesia: Proof of Concept

During general anaesthesia, intraoperative hypotension (IOH), defined as a mean arterial pressure (MAP) drop of more than 20%, is frequent with potential deleterious effects for patients. Pulse oximeter is mandatory in the operating room making photoplethysmographic (PPG) signal and parameters such as the relative dicrotic notch height (Dicpleth) or the perfusion index (PI) readily available. The purpose of this study is to investigate whether Dicpleth and PI could detect IOH during anaesthesia induction and follow their variations during vasopressor boluses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

Main objective Haemodynamic stability is a major issue in the management of patients during general anaesthesia. Anaesthetic drugs induce rapid and deep systemic arterial blood pressure (ABP) drop which leads to intra operative hypotension (IOH) episodes. IOH can cause deleterious consequences such as myocardial infraction, cerebral hypoperfusion or acute kidney injury.

The major drawback of the oscillometric cuff is to measure ABP only at intermittent intervals. As ABP may vary quickly, especially during induction of anaesthesia, IOH should be detected in real time as even a short period of IOH may have deleterious consequences on vital organs.

Digital photoplethysmography (PPG) is a non-invasive signal produced by light absorption variations due to pulsatile blood volume variations. Indices derived from PPG signals have been used successfully to characterize cardiovascular state in patients.

Dicrotic notch height (Dicpleth), representing the relative height of the dicrotic wave compared to the maximum peak of the waveform, has been described as the amount of reflected wave, dependent of the vascular tone. Reduction in Dicpleth has been shown to be related to reduction of vascular tone due to vasodilator drugs such as salbutamol or glyceryl Trinitrate.

Perfusion Index (PI) represents the ratio of the pulsatile light absorption (i.e the amount of blood ejected at each systole) on the continuous absorption (corresponding to the non-pulsatile vessels, bones and soft tissues). PI has been described as a reliable tool for vascular tone assessment and monitoring

Primary Evaluation Criteria As Dicpleth and PI are both related to vascular tone and are easily derived from the PPG signal, Investigators aimed to explore whether the combined analysis of Dicpleth and PI variations would allow for early detection of IOH during the during a standardized propofol-remifentanil anesthesia induction.

Estimate the correlations between variations of Dicpleth and MAP, and PI and MAP during induction of anaesthesia and during bolus of vasopressors.

Estimate if a combined analysis of these two parameters enhanced diagnostic performance for detecting IOH under actions of vasoactive effect of anaesthetics.

Experimental design This is a single-center, interventional, category II prospective study (minimal risks and constraints) Population concerned The study involves major patients who beneficiate from intraoperative hemodynamic optimization with norepinephrine (as noradrenaline tartrate) for maintaining blood pressure under general anaesthesia in interventional neuroradiology in adults.

Research Proceedings Hemodynamic parameters (heart rate, systolic arterial pressure [SAP], mean arterial pressure [MAP] and diastolic arterial pressure [DAP]), and PPG parameters (Dicpleth, PI and SpO2) will be retrospectively sampled every minute during induction. All monitoring parameters and curves displayed on the monitor will be recorded on a computer with ixTrend© software (ixellence, Wildau, Germany). Investigators defined "pre-pressor" values as the measures prior to the vasopressor bolus during IOH episodes. "Peak-pressor" values is defined as the maximum effects of vasopressor bolus, when the highest MAP is reached. In agreement with most studies, IOH is defined as a MAP drop of more than 20% from baseline MAP.

In patients presenting a hypotensive episode, all parameters are collected before and at the peak effect of a 10µg bolus of norepinephrine

Individual benefit:

There is no benefit for the patient

Collective benefit:

As ABP may vary quickly, especially during induction of anaesthesia, IOH should be detected in real time as even a short period of IOH may have deleterious consequences on vital organs. The non-invasive combined analysis of Dicpleth and PI variations would allow for early detection of IOH during the induction of general anaesthesia.

Risks and minimal constraints added by the research No added risk This clinical research work is "non-interventional" on adult patients who benefit from a neuroradiological intervention. All measures are obtained non-invasively.

During their interventional neuroradiology procedure, all patients' routine monitoring will consist of electrocardiogram, pulsated oxygen saturation, end-tidal CO2, respiratory rate, tidal volume and monitoring of neuromuscular function.

For all patients whatever the comorbidities, anesthesia induction will be performed using a target-controlled infusion (Orchestra® Base Primea - Fresenius Kabi France).

In agreement with most studies, IOH is defined as a MAP drop of more than 20% from baseline MAP.

Hemodynamic parameters (heart rate, systolic arterial pressure [SAP], mean arterial pressure [MAP] and diastolic arterial pressure [DAP]), and PPG parameters (Dicpleth, PI and SpO2) will be retrospectively sampled every minute during induction.

In patients presenting a hypotensive episode, all parameters are collected before and at the peak effect of a 10µg bolus of norepinephrine.

Number of selected subjects The primary aim of the study is to estimate the AUC of the ROC curve of both ΔDicpleth and ΔPI to track IOH during induction. Sample size was determined with an expected AUC at 0.85, an expected incidence of hypotension of 80% and the width of the confidence interval of 1. With a power of 80%, the number of patients to include was then 62.15 Secondary objective is to evaluate AUC of the ROC curve for combination of ΔDicpleth and ΔPI.

Statistics Changes of the parameters are analysed using Wilcoxon rank test. Correlation tests between ΔDicpleth and ΔMAP in one hand, and ΔPI and ΔMAP are performed by using Spearman test. Areas under the curve (AUC) of Receiver Operating Characteristic (ROC) curve (with 95% confidence interval) of ΔDicpleth and ΔPI to detect IOH episode will be estimated and eventually compared using DeLong test. Youden method is used to determine the optimal ΔDicpleth and ΔPI cut-off values to detect IOH episodes. Values are expressed as median and interquartile range [25th;75th percentiles]. P<0.05 is considered as statistically significant. Statistical analysis is performed using Prism 6.00© (Graphpad Software, Inc, La Jolla, CA, USA) and R 3.3.0 software (R foundation for Statistical Computing, Vienna, Austria).

Patients who have non-measurable Dicpleth at baseline before induction of anaesthesia will be excluded from the analysis

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with scheduled an elective interventional neuroradiology procedure requiring general anesthesia

Description

Inclusion Criteria:

  • patients > 18 years, scheduled an elective interventional neuroradiology procedure requiring general anesthesia
  • oral agreement obtained from each patient before anesthesia

Exclusion Criteria:

  • age <18 years
  • an emergency procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Continuous measure of mean arterial pressure (MAP in mmHg)
Time Frame: Time Frame: duration of the interventional neuroradiology procedure: 1 day
We calculated the variation of MAP during the induction period from the relative variations (in percent) from their baseline values. During vasopressor boluses, respective parameter's variations are calculated between "pre-pressor" and "peak-pressor" measurements.
Time Frame: duration of the interventional neuroradiology procedure: 1 day
Continuous measure of SpO2 in % by photoplethysmography
Time Frame: Time Frame: duration of the interventional neuroradiology procedure: 1 day
We calculated variations of Dicpleth, and perfusion index (PI) during the induction period from the relative variations (in percent) from their baseline values. During vasopressor boluses, respective parameter's variations are calculated between "pre-pressor" and "peak-pressor" measurements.
Time Frame: duration of the interventional neuroradiology procedure: 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hopital Lariboisière

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
INSERM UMR-942, Paris, France
M3DISIM

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joaquim MATEO, MD, Hopital Lariboisiere

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 23, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JMATEO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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