Prediction of Hemodynamic Response to Intubation by ANI Variation During Standardized Stimulation (ANI_LARYNGO)

Relationship Between the ANI Score During Standardized Painful Stimulation and the Nociceptive Response to Laryngoscopy Intubation

The objective : to investigate a correlation between ANI following a standardized nociceptive stimulus and hemodynamic or somatic reactions during orotracheal intubation.

Piloted study. ANI and hemodynamic and somatic parameters response associated tetanus stimulation followed by orotracheal intubation were collected.

Study Overview

• Status: Completed
• Conditions: Pain; Tracheal Intubation Morbidity
• Intervention / Treatment: Device: ANI

Detailed Description

Background: The Analgesia Nociception Index reflects the balance between analgesia and nociception and allows early detection of a defect in analgesia. Orotracheal intubation is responsible for a sometimes deleterious hemodynamic reaction. The Analgesia Nociception Index could allow an individual adjustment of the investigator's anesthetic inductions during this period.

Objective: The objective of this study is to investigate if there is a correlation between variations in the ANI following a standardized nociceptive stimulus and the occurrence of hemodynamic or somatic reactions during orotracheal intubation without muscle relaxation.

Materials and Methods: Prospective, interventional, analytical, monocentric, piloted study carried out in the operating theatre after obtaining patient's informed consent between January 2014 and November 2014. Under steady state total intravenous anaesthesia with propofol and remifentanil at constant dosage (entropy between 40 and 60) tetanus stimulation of the ulnar nerve was performed followed by orotracheal intubation. The variation of ANI and hemodynamic parameters as well as the somatic response associated with both maneuvers were collected.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hopital Roger Salengro, CHU Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any patient requiring general anaesthesia with tracheal intubation by direct laryngoscopy
• Intubation Difficulty Assessment Score < 7
• BMI between 17 and 30 Kg/m2
• Socially insured patient
• Patient 18 years of age or older
• Patient with signed consent
• Patient with a sinus heart rhythm

Exclusion Criteria:

• Patient refusing to participate in the study
• Pregnant woman
• Patient with a pace maker (any mode)
• Patient treated with Beta Blocker
• Known Dysautonomia
• Diabetes
• Spontaneous ventilation anaesthesia
• Allergy to any of the required medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental; Anesthetic induction : total target-controlled intravenous anesthesia d was used with propofol and remifentanil. The effect site was then gradually increased to obtain a satisfaction depth of anesthesia. Assisted ventilation was then started by facemask ventilation (Sat O2>95% and expired CO2 fraction normal, tidal volume of 8 mL/kg, a respiratory rate of 12 cycles per minute, with an FiO2 100% with no positive end expiratory pressure. After stabilisation period of 2 minutes and record of the patient's parameters, a standardized nociceptive stimulation was applied at the level of the ulnar nerve (PTC of 50 Hz at 70 mA). The variation of ANI score and hemodynamic parameters were collected during the 2 following minutes. After stabilization of ANI, orotracheal intubation was attempted. Maximal variation of heart rate (HR), blood pressure and the occurrence of somatic manifestations (intense cough, movement, tears) were recorded.

Device: ANI; Under steady state total intravenous anaesthesia with propofol and remifentanil at constant dosage, tetanus stimulation of the ulnar nerve was performed followed by orotracheal intubation. The variation of ANI and hemodynamic parameters as well as the somatic response associated with both maneuvers were collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
predictability of hemodynamic impact during laryngoscopy by tetanus-induced ANI variation,	area under the corresponding Receiver Operating Characteristic curve with DeltaTetanus as dependent variable, and Hemodynamic Impact as state variable	measurement during intubation, an average 40 seconds and 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
predictability of somatic impact during laryngoscopy by tetanus-induced ANI variation,	area under the corresponding Receiver Operating Characteristic curve with DeltaTetanus as dependent variable, and Somatic Impact as state	observation during intubation, an average between 40 seconds and 5 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Elsa Jozefowicz, MD, University Hospital, Lille

Publications and helpful links

General Publications

• Jozefowicz E, Sabourdin N, Fontaine V, Lambelin V, Lejeune V, Menu H, Bourai M, Tavernier B. Prediction of reactivity during tracheal intubation by pre-laryngoscopy tetanus-induced ANI variation. J Clin Monit Comput. 2022 Feb;36(1):93-101. doi: 10.1007/s10877-020-00624-6. Epub 2021 Jan 2.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: tracheal intubation; ANI; hemodynamic responses
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 2012_34; 2013-A01127-38 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No