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Prediction of Pre-operative Anxiety by Heart Variability and Pupillometry (INNOVANX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154410
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to determine whether heart rate variability levels and pupillometric measures are effective objective predictors of anxiety among patients before surgery.

Condition or disease Intervention/treatment
Eligible for Day Case Surgery Other: Analgesia Nociception Index Other: algiscan

Detailed Description:

The prevalence of preoperative anxiety in adults is estimated between 60 and 80% and prevents a good integration of the information delivered, while seeking more attention from caregivers. In addition, anxious patients require the administration of higher doses of hypnotics at anesthetic induction. The pain expressed in the postoperative period is proportional to preoperative anxiety, with a slower recovery kinetics responsible for prolonged stay in the recovery room. Finally, the incidence of chronic pain is correlated with the intensity of preoperative anxiety.

While the recommendations of the European Anesthesia Society (ESA) emphasize the importance of managing preoperative anxiety, this dimension is often overlooked and existing methods of assessment are time consuming and sometime inaccurate.

Objective screening with dynamic monitoring of the level of anxiety in real time is the necessary step to ensure accurate detection and personalized management of the emotional state of patients before performing an invasive procedure.

Anxiety is an emotional state reflecting an imbalance of cortico-frontal regulation on the limbic system. The interaction between these two neuronal systems is expressed in particular by the intensity of the vagal tone and the autonomic nervous system. Exploring the balance between sympathetic and parasympathetic systems is a promising avenue of exploration for identifying, predicting, and treating anxiety.

Two reliable and easy-to-use devices analyzing the expression of the autonomic nervous system validated in the analysis of nociception in the awake patient or under general anesthesia are marketed:

A. Analgesia Nociception Index (ANI) (MDoloris Medical Systems) analyzing oscillatory changes in heart rate as a function of respiratory time, namely the heart rate variability (HRV) B. Algiscan (IDMed) analyzing pupil responsiveness to nociception

The use of these devices in conscious pre-operative patients could allow a reliable and objective detection of anxiety while following its kinetic evolution over time. The purpose of this project is to evaluate the validity of these two devices in the context of preoperative anxiety. After receiving clear information and giving their written agreement, patients will be included in the study by the anesthetist physician. During the anesthesia consultation, the included patients will be subjected to a self-assessment Hospital Anxiety Depression Scale (HADS) questionnaire of level of anxiety.

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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of the Non Invasive Objective Assessment of Pre-operative Anxiety Using the Heart Rate Variability and the Pupillary Reflex Measurement
Estimated Study Start Date : December 10, 2019
Estimated Primary Completion Date : June 10, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety


Intervention Details:
  • Other: Analgesia Nociception Index
    Non invasive finger tip monitoring before during and 5 minutes after cannulation
    Other Name: Heart rate variability measures
  • Other: algiscan
    Portable videopupillometer to measure pupillary light reflex (PLR), variation coefficient of pupillary diameter (VCPD), pupillary diameter (PD) fluctuations before, during and 5 minutes after cannulation
    Other Name: Pupillometric measures


Primary Outcome Measures :
  1. Heart rate variability comparison between anxious and non-anxious patients [ Time Frame: at Day 0 ]
    Variation before during and 5 minutes after cannulation


Secondary Outcome Measures :
  1. Comparison of pupillary light reflex between anxious and non-anxious patients [ Time Frame: at Day 0 ]
    Variation before during and 5 minutes after cannulation

  2. Comparison of variation coefficient of pupillary diameter between anxious and non-anxious patients [ Time Frame: at Day 0 ]
    Variation before during and 5 minutes after cannulation

  3. Comparison of pupillary diameter between anxious and non-anxious patients [ Time Frame: at Day 0 ]
    Variation before during and 5 minutes after cannulation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elective patients for day-case surgical procedure
Criteria

Inclusion Criteria:

-Day case surgical patients

Exclusion Criteria:

  • <18yo
  • psychiatric disorders
  • participating refusal

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): NCT04154410


Contacts
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Contact: Gilles GUERRIER, MD (33)+158414141 gilles.guerrier@aphp.fr
Contact: Caroline TOURTE (33)+1158411190 caroline.tourte@aphp.fr

Locations
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France
Cochin Hospital, APHP
Paris, France, 75014
Contact: Gilles GUERRIER, MD    (33)+1158414141    gilles.guerrier@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Gilles GUERRIER, MD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04154410    
Other Study ID Numbers: APHP190697
2019-A01743-54 ( Other Identifier: ID-RCB )
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pre-operative anxiety
pupillometry
heart rate variability
cardiac coherence state
ambulatory surgery
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders