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

NCT04354311 | Completed

• 2 other identifiers: 2012_342013-A01127-38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tracheal Intubation Morbidity; Pain

Keywords

ANI; hemodynamic responses; tracheal intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• predictability of somatic impact during laryngoscopy by tetanus-induced ANI variation,

  observation during intubation, an average between 40 seconds and 5 minutes

Study Arms (1)

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

Interventions

ANI DEVICE

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location

Related Publications (1)

• 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.

  PMID: 33387153 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elsa Jozefowicz, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients under general anesthesia during the procedure
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, interventional, analytical, monocentric, piloted study

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 21, 2020
• Study Start: February 2, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 22, 2025

Record last verified: 2020-04

Locations

FR (1)