Patient State Index at Laryngoscopy and Tracheal Intubation Conditions

Condition(s) studied

Investigational drug(s) / intervention(s)

Depth of anesthesia at laryngoscopy (Patient State Index): Exposure of interest, not an assigned intervention. The Patient State Index is measured with routinely used SedLine processed-EEG monitoring at the moment of laryngoscopy. The display is kept out of view of the intubating anesthesiologist until intubation conditions have been graded. No aspect of anesthetic management is directed by the protocol.

Study summary

The goal of this observational study is to learn whether the depth of anesthesia at the moment the breathing tube is placed is related to how easily the tube can be placed, in adult women (18 to 65 years) having planned surgery under general anesthesia. Depth of anesthesia is measured with the Patient State Index (PSI), a number from 0 to 100 shown by a brain-activity monitor (SedLine) with a sensor placed on the forehead; lower numbers mean deeper anesthesia.

The main questions it aims to answer are:

* Is the PSI at the moment of tube placement related to the quality of intubation conditions: how relaxed the jaw is, how open the vocal cords are, and whether the patient coughs or moves?
* Does the PSI tell the anesthesia team something about these conditions beyond what they already know from the anesthetic dose, the timing of the muscle relaxant, and the patient's age?

There is no comparison group; all participants are in one group.

Participants will:

* Receive their usual anesthesia care. The study does not change any drug, dose or timing, and all decisions stay with their anesthesiologist.
* Have their depth of anesthesia and muscle relaxation recorded with monitors that are already part of routine care at this hospital. While the breathing tube is being placed, the brain-activity monitor screen is turned away from the anesthesiologist placing the tube, and a second doctor watches it the whole time.
* Answer a few short questions on the day after surgery about sore throat, hoarseness, and whether they remember anything from the operation.

Eligibility

Primary outcome measure(s)

• Composite Intubation Condition Score — At laryngoscopy (T2), typically within 10 minutes of the start of induction of anesthesia
  Composite intubation condition score (range 0-6; higher scores indicate better conditions): the sum of the three Good Clinical Research Practice (GCRP) 2023 components (ease of laryngoscopy, vocal cord position, reaction to intubation), each scored excellent 2, good 1, or poor 0, graded by the intubating anesthesiologist blinded to the Patient State Index (PSI). Analyzed as the odds ratio (95% CI) per 10-unit increase in PSI at laryngoscopy, from a proportional odds ordinal logistic regression adjusted for predicted propofol effect-site concentration, interval from neuromuscular blocking agent to laryngoscopy, and age.

Trial sites (1)

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