Voice Analysis as a Predictor for Difficult Intubations
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Massachusetts
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Worcester、Massachusetts、アメリカ、01655
- UMASS Memorial - Medical School Campus
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Difficult airways
Documented history of difficult airways.
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Control (Not difficult airways)
Age matched with normal airways to be used as controls
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Audio Samples to Predict Difficult Intubation
時間枠:15-20 minutes
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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.
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15-20 minutes
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協力者と研究者
スポンサー
捜査官
- 主任研究者:J. M Walz, MD、UMass Medical School
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- H00012814
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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