Prediction of Pre-operative Anxiety by Heart Variability and Pupillometry

Eligible for Day Case Surgery Clinical Trial

— INNOVANX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04154410
• Other study ID #: APHP190697
• Secondary ID: 2019-A01743-54
• Status: Completed
• Start date: June 30, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 Surgical Fear Questionnaire (SFQ) questionnaire of level of anxiety.

A secondary study will consist of connecting a lighting device connected to the heart rate variability to emit a relaxing light in the preoperative waiting room.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Day case surgical patients

Exclusion Criteria:

• <18yo

• psychiatric disorders

• participating refusal

Related Conditions & MeSH terms

• Eligible for Day Case Surgery

Intervention

Other:
• Analgesia Nociception Index
Non invasive finger tip monitoring before during and 5 minutes after cannulation
• 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

Locations

Country	Name	City	State
France	Cochin Hospital, APHP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesia Nociception Index (ANI)	Index from 0 to 100 Variation 5 minutes before during and 5 minutes after cannulation Comparison between anxious and non-anxious patients Measure of anxiety reduction	at Day 0
Secondary	Coefficient of variation of pupillary diameter (CVDP)	Percentage from 0 to 100% Variation 5 minutes before during and 5 minutes after cannulation Comparison between anxious and non-anxious patients	at Day 0
Secondary	Visual Analog Scale (VAS)	Measure of anxiety reduction 30 minutes after the beginnig of the luminous immersion	at Day 0
Secondary	Heart rate variability	comparison between anxious and non-anxious patients Variation 5 minutes before during and 5 minutes after cannulation	at Day 0
Secondary	Analgesia Nociception Index (ANI)	Impact of 30 minutes immersive light intervention on measures of ANI and VAE	at Day 0 - after 30 minutes immersive light intervention
Secondary	Visual Analog Scale (VAS)	Impact of 30 minutes immersive light intervention on measures of ANI and VAS	at Day 0 - after 30 minutes immersive light intervention