Voice Analysis as a Predictor for Difficult Intubations

NCT04105738 | Terminated Results

• 1 other identifier: H00012814
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Difficult Intubation; Difficult Airway Intubation; Speech Dysfunction; Surgery

Keywords

Difficult Intubation; Preoperative Surgical Assessment; Speech Dysfunction; Difficult Airway

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Difficult airways

Documented history of difficult airways.

Control (Not difficult airways)

Age matched with normal airways to be used as controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• J. Matthias Walz: lead

Study Sites (1)

UMASS Memorial - Medical School Campus

Worcester, Massachusetts, 01655, United States

Location

Related Publications (5)

• 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.

  PMID: 9771306 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.

  PMID: 8457045 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.

  PMID: 8055603 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.

  PMID: 8404173 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.

  PMID: 9349877 BACKGROUND

Limitations and Caveats

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.

Results Point of Contact

• Title: Arlene Williams
• Organization: University of Massachusetts

arlene.williams@umassmed.edu

508-856-5584

Study Officials

• J. M Walz, MD

  UMASS Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2019
• First Posted: September 26, 2019
• Study Start: March 28, 2017
• Primary Completion: February 19, 2021
• Study Completion: February 22, 2021
• Last Updated: March 15, 2022
• Results First Posted: March 15, 2022

Record last verified: 2022-01

Locations

US (1)