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New monitor may predict pain during intubation

NCT ID NCT04354311

Knowledge-focused Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a device that measures heart rate patterns (called ANI) can predict pain responses when inserting a breathing tube. Researchers gave 60 patients a mild electric shock to mimic pain, then inserted the tube. They found that changes in the ANI score might help anesthesiologists anticipate pain and adjust medication. The goal is to improve patient comfort and safety during anesthesia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better ways to monitor and manage pain during anesthesia, making intubation safer and more comfortable.
What could go wrong
This is a small, completed pilot study with only 60 participants. Results may not apply to all patients or settings, and the ANI score may not reliably predict pain responses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Feb 2014

Finished

Dec 2014

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain Tracheal intubation morbidity

Contacts and locations

Locations

  • Hopital Roger Salengro, CHU Lille

    Lille, 59037, France

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Other studies related to the condition(s) this trial covers.