AnesthesiaNCT04105738
Voice Analysis as a Predictor for Difficult Intubations
An observational study of Anesthesia and Difficult Intubation, run by J. Matthias Walz at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Difficult Intubation, Difficult Airway Intubation
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2017to 22 Feb 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with a documented history of difficult airways and subjects of the same age (matched for age) with normal airways to be used as controls. Patient are labeled as a difficult airway during their hospitalization, they are given a copy of the difficult airway documentation so the patient should be aware already that they are labeled as a difficult airway.
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMASS Memorial - Medical School Campus
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Conditions
- Anesthesia, Difficult Intubation, Difficult Airway Intubation, Speech Dysfunction, Surgery
- Keywords
- Difficult Intubation, Preoperative Surgical Assessment, Speech Dysfunction, Difficult Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Difficult airways | Documented history of difficult airways. | |
| Control (Not difficult airways) | Age matched with normal airways to be used as controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start28 Mar 2017
- Primary completion19 Feb 2021
- Study completion22 Feb 2021
Why it stopped: Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- J. Matthias Walz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, J. Matthias Walz, University of Massachusetts, Worcester
- Investigators
- J. M Walz, MD, Principal investigator, UMASS Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105738
- Sponsor's protocol ID
- H00012814
- Status last verified
- Jan 2022
- First submitted
- 24 Aug 2019
- Last updated
- 15 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Asai T, Koga K, Vaughan RS. Respiratory complications associated with tracheal intubation and extubation. Br J Anaesth. 1998 Jun;80(6):767-75. doi: 10.1093/bja/80.6.767.
PubMed 9771306Moller JT, Johannessen NW, Espersen K, Ravlo O, Pedersen BD, Jensen PF, Rasmussen NH, Rasmussen LS, Pedersen T, Cooper JB, et al. Randomized evaluation of pulse oximetry in 20,802 patients: II. Perioperative events and postoperative complications. Anesthesiology. 1993 Mar;78(3):445-53. doi: 10.1097/00000542-199303000-00007.
PubMed 8457045Rose DK, Cohen MM. The airway: problems and predictions in 18,500 patients. Can J Anaesth. 1994 May;41(5 Pt 1):372-83. doi: 10.1007/BF03009858.
PubMed 8055603Fiz JA, Morera J, Abad J, Belsunces A, Haro M, Fiz JI, Jane R, Caminal P, Rodenstein D. Acoustic analysis of vowel emission in obstructive sleep apnea. Chest. 1993 Oct;104(4):1093-6. doi: 10.1378/chest.104.4.1093.
PubMed 8404173Robb MP, Yates J, Morgan EJ. Vocal tract resonance characteristics of adults with obstructive sleep apnea. Acta Otolaryngol. 1997 Sep;117(5):760-3. doi: 10.3109/00016489709113474.
PubMed 9349877
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Analysis as a Predictor for Difficult Intubations
- ClinicalTrials.gov ID
- NCT04105738
- Acronym / sponsor ID
- H00012814
- Conditions
- Anesthesia, Difficult Intubation, Difficult Airway Intubation, Speech Dysfunction, Surgery
- Keywords
- Difficult Intubation, Preoperative Surgical Assessment, Speech Dysfunction, Difficult Airway
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- J. Matthias WalzUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Posted 15 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difficult airways | – | –Documented history of difficult airways. |
| Control (Not difficult airways) | – | –Age matched with normal airways to be used as controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a documented history of difficult airways and subjects of the same age (matched for age) with normal airways to be used as controls. Patient are labeled as a difficult airway during their hospitalization, they are given a copy of the difficult airway documentation so the patient should be aware already that they are labeled as a difficult airway.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Audio Samples to Predict Difficult Intubation
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9771306Asai T, Koga K, Vaughan RS. Respiratory complications associated with tracheal intubation and extubation. Br J Anaesth. 1998 Jun;80(6):767-75. doi: 10.1093/bja/80.6.767.
- Background: PubMed 8457045Moller JT, Johannessen NW, Espersen K, Ravlo O, Pedersen BD, Jensen PF, Rasmussen NH, Rasmussen LS, Pedersen T, Cooper JB, et al. Randomized evaluation of pulse oximetry in 20,802 patients: II. Perioperative events and postoperative complications. Anesthesiology. 1993 Mar;78(3):445-53. doi: 10.1097/00000542-199303000-00007.
- Background: PubMed 8055603Rose DK, Cohen MM. The airway: problems and predictions in 18,500 patients. Can J Anaesth. 1994 May;41(5 Pt 1):372-83. doi: 10.1007/BF03009858.
- Background: PubMed 8404173Fiz JA, Morera J, Abad J, Belsunces A, Haro M, Fiz JI, Jane R, Caminal P, Rodenstein D. Acoustic analysis of vowel emission in obstructive sleep apnea. Chest. 1993 Oct;104(4):1093-6. doi: 10.1378/chest.104.4.1093.
- Background: PubMed 9349877Robb MP, Yates J, Morgan EJ. Vocal tract resonance characteristics of adults with obstructive sleep apnea. Acta Otolaryngol. 1997 Sep;117(5):760-3. doi: 10.3109/00016489709113474.
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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.
J. M Walz, MD principal investigator
UMASS Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Difficult Intubation, run by J. Matthias Walz at 1 site in United States.
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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 15 Mar 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Audio Samples to Predict Difficult Intubation (time frame: 15-20 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 NCT04105738, which also lists 5 linked publications.
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 15 Mar 2022.