Prediction of Pre-operative Anxiety by Heart Variability and Pupillometry (INNOVANX)
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|ClinicalTrials.gov Identifier: NCT04154410|
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment|
|Eligible for Day Case Surgery||Other: Analgesia Nociception Index Other: algiscan|
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.
|Study Type :||Observational|
|Estimated Enrollment :||72 participants|
|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|
- Other: Analgesia Nociception Index
Non invasive finger tip monitoring before during and 5 minutes after cannulationOther 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 cannulationOther Name: Pupillometric measures
- Heart rate variability comparison between anxious and non-anxious patients [ Time Frame: at Day 0 ]Variation before during and 5 minutes after cannulation
- Comparison of pupillary light reflex between anxious and non-anxious patients [ Time Frame: at Day 0 ]Variation before during and 5 minutes after cannulation
- 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
- Comparison of pupillary diameter between anxious and non-anxious patients [ Time Frame: at Day 0 ]Variation before during and 5 minutes after cannulation
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
|Contact: Gilles GUERRIER, MD||(33)+email@example.com|
|Contact: Caroline TOURTE||(33)+firstname.lastname@example.org|
|Cochin Hospital, APHP|
|Paris, France, 75014|
|Contact: Gilles GUERRIER, MD (33)+1158414141 email@example.com|
|Principal Investigator:||Gilles GUERRIER, MD||Assistance Publique - Hôpitaux de Paris|