Tracheal Intubation MorbidityANI_LARYNGONCT04354311
Prediction of Hemodynamic Response to Intubation by ANI Variation During Standardized Stimulation
A study testing ANI in people with Tracheal Intubation Morbidity and Pain, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tracheal Intubation Morbidity, Pain
- What is being tested?
- ANI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tracheal Intubation Morbidity, Pain
- Being tested
- ANI
- Keywords
- ANI, hemodynamic responses, tracheal intubation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ANI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: measurement during intubation, an average 40 seconds and 5 minutes
Secondary outcomes (1)
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
Measured: observation during intubation, an average between 40 seconds and 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start2 Feb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tracheal Intubation MorbidityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, interventional, analytical, monocentric, piloted study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elsa Jozefowicz, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354311
- Sponsor's protocol ID
- 2012_34
- Other IDs
- 2013-A01127-38
- Acronym
- ANI_LARYNGO
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33387153
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the ANI Score During Standardized Painful Stimulation and the Nociceptive Response to Laryngoscopy Intubation
- ClinicalTrials.gov ID
- NCT04354311
- Acronym / sponsor ID
- ANI_LARYNGO / 2012_34
- Conditions
- Tracheal Intubation Morbidity, Pain
- Keywords
- ANI, hemodynamic responses, tracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 2 Feb 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, interventional, analytical, monocentric, piloted study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: ANIAnesthetic 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Patient refusing to participate in the study
- Pregnant woman
- Patient with a pace maker (any mode)
- Patient treated with Beta Blocker
- Known Dysautonomia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANIUnder 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. | Device | Experimental |
Primary outcome
predictability of hemodynamic impact during laryngoscopy by tetanus-induced ANI variation,
Time frame: measurement during intubation, an average 40 seconds and 5 minutes
area under the corresponding Receiver Operating Characteristic curve with DeltaTetanus as dependent variable, and Hemodynamic Impact as state variable
1 secondary outcome
predictability of somatic impact during laryngoscopy by tetanus-induced ANI variation,
Time frame: observation during intubation, an average between 40 seconds and 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 33387153Jozefowicz 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.
Related trials for Tracheal Intubation Morbidity
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Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elsa Jozefowicz, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANI in people with Tracheal Intubation Morbidity and Pain, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictability of hemodynamic impact during laryngoscopy by tetanus-induced ANI variation, (time frame: measurement during intubation, an average 40 seconds and 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04354311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.