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Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Difficult airways | Documented history of difficult airways. | ||
| Control (Not difficult airways) | Age matched with normal airways to be used as controls |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15-20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
We will not include:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| J. M Walz, MD | UMASS Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMASS Memorial - Medical School Campus | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9771306 | Background | 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. | |
| 8457045 | Background | Moller 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Difficult Airways | Documented history of difficult airways. |
| FG001 | Control (Not Difficult Airways) | Age matched with normal airways to be used as controls |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Difficult Airways | Documented history of difficult airways. |
| BG001 | Control (Not Difficult Airways) | Age matched with normal airways to be used as controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | 15-20 minutes |
|
Adverse events were collected during study participation of 1 day.
Below minimal risk study and participation of 1 day resulted in no adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Difficult Airways | Documented history of difficult airways. | 0 |
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Due to technical issues, audio recording could not be uploaded or analyzed as anticipated/planned for study, and enrollment did not meet expectations. Therefore, no analysis or results for the study are available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arlene Williams | University of Massachusetts | 508-856-5584 | arlene.williams@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2019 | Nov 23, 2021 | Prot_SAP_000.pdf |
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| 8055603 | Background | Rose 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. |
| 8404173 | Background | Fiz 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. |
| 9349877 | Background | Robb 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Age matched with normal airways to be used as controls |
|
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Control (Not Difficult Airways) | Age matched with normal airways to be used as controls | 0 | 0 | 0 | 0 | 0 | 0 |
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