Anesthesia, Difficult Airway Intubation, Difficult Intubation, Speech Dysfunction, Surgery
Conditions
Keywords
Difficult Intubation, Preoperative Surgical Assessment, Speech Dysfunction, Difficult Airway
Brief summary
To investigate if signal processing can detect subtle changes in speech production clinically relevant to oropharynx anatomy that may provide an objective measure in the assessment of the presumed difficulty of intubation.
Detailed description
The purpose of this study is to investigate whether changes in phonation (sounds coming from vocal cords that occur when a person speaks) can be used as a reliable measure to predict airways that may be difficult to manage in the operating room. One of the reasons the Preoperative Surgical Assessment (PSE) is performed is to assess subjects for signs of a difficult airway. At this time, none of the assessments have proven to be both highly sensitive and specific. Multiple studies have shown that specific characteristics of a subject's speech can suggest that they may have an issue with the anatomy of the oropharynx (the area consisting of the back of the throat to the vocal cords). Prior research has shown that studying velar vowel sounds, those vowels that require the use of the back of the tongue to pronounce, can be used to predict a disorder called obstructive sleep apnea (a disease associated with difficulty breathing). The Investigators are trying to determine whether the development of a simple voice study conducted during the PSE visit could alert the Anesthesiologist caring for the subject in the operating room to use the extra precautions provided for people who have a documented history of a difficult airway. It is hoped that the voice analysis test being developed in this study will have the ability to objectively predict a difficult airway for future patients.
Interventions
None listed
Sponsors
J. Matthias Walz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Able to provide informed consent * A known documented history of having a difficult airway * An age-matched control subject with normal airways.
Exclusion criteria
* Unable to consent for themselves * Non-English speaking subjects * Pregnant Subjects * Previous Vocal Cord Surgery * Previous Head and neck surgery that would alter anatomy of hypopharynx We will not include: * Prisoners * Pregnant women * Individuals who are not yet adults (infants, children, teenagers) * Adults unable to consent * Adults who cannot speak English We will not be enrolling subjects who cannot speak English. The subjects must be able to understand the research team member who is testing them as well as the research paradigm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Audio Samples to Predict Difficult Intubation | 15-20 minutes | An audio sample from each participant will be broken down into its signal components using signal-processing methods to evaluate whether there are differences between the two participant groups which may correlate to difficult intubation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Difficult Airways Documented history of difficult airways. | 13 |
| Control (Not Difficult Airways) Age matched with normal airways to be used as controls | 0 |
| Total | 13 |
Baseline characteristics
| Characteristic | Difficult Airways | Total | Control (Not Difficult Airways) |
|---|---|---|---|
| Age, Continuous | 59 years | 59 years | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants | 13 Participants | 0 Participants |
| Region of Enrollment United States | 13 Participants | 13 Participants | — |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 0 |
| other Total, other adverse events | 0 / 13 | 0 / 0 |
| serious Total, serious adverse events | 0 / 13 | 0 / 0 |
Outcome results
Primary
Audio Samples to Predict Difficult Intubation
An audio sample from each participant will be broken down into its signal components using signal-processing methods to evaluate whether there are differences between the two participant groups which may correlate to difficult intubation.
Time frame: 15-20 minutes
Population: Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Signal processing of the audio samples did not work as anticipated and could not be abstracted or analyzed. Additionally, not enough participants were enrolled, including lack of enrollment to the control group, to analyze data.