Evaluation of the Relationship Between Airway Measurements and Laryngoscopic View in Newborn and Infants
Evaluation of the Relationship Between Airway Measurements With Ultrasonography and Laryngoscopic View in Newborn and Infants
Background and Aim: The overall incidence of difficult laryngoscopy in pediatric anesthesia is lower than in adults, but this risk is higher in patients younger than one year of age. In the last decade, different measurements have been used to obtain difficult laryngoscopy markers in children. In this study, we aimed to evaluate the relationship between the airway measurements (some performed by using ultrasonography (USG)) and the difficult laryngoscopic view in neonates and infants.
Design: This is a prospective, single blinded, observational study. The number of patients was calculated as follows: A sample of 12 from the positive group (difficult laryngoscopy group) and 96 from the negative group (easy laryngoscopy group) achieve 80% power to detect a difference of 0.25 between the area under the ROC curve (AUC) under the null hypothesis of 0.50 and an AUC under the alternative hypothesis of 0,75 using a two-sided z-test at a significance level of 0.05.
Methods: All patients which is newborn and infant age group undergoing elective surgery requiring intubation under general anesthesia are assessed. Patients' age, body mass index (BMI), thyromental distance, mandibula length, the distance between the lip corner and ipsilateral ear tragus, and the transverse length (measured by hand sign-middle-ring fingers adjacent side by side) measurements are recorded. In thyromental distance measurement, "thyroid notch" are determined by USG.
The laryngoscopic view is graded by a different experienced anaesthetist who is blinded to the airway measurements.
Statistical analysis:
Receiver operating characteristic (ROC) curves are used to determine the best cut-off point for distance variables in the separation of difficult and easy laryngoscopy groups. Sensitivity, selectivity, positive predictive value and negative predictive values of lengths are calculated according to determined cut point.The difference between the two groups in terms of qualitative variables are evaluated by chi-square or Fisher's exact test. The normal distribution of the numerical variables are examined with the Shapiro-Wilk test. The difference between the two groups in terms of numerical variables are investigated by Mann Whitney U test. Values of p <0.05 are considered as statistically significant.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Ankara、七面鳥、06110
- Ankara Childrens' Health and Diseases Hematology Oncology Training and Research Hospital
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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:
- Newborn and infant age group
- Undergoing elective surgery requiring intubation under general anesthesia
Exclusion Criteria:
- History of congenital maxillofacial defect,
- History of upper airway pathology (tumor, cleft palate-lips, etc.)
- History of head and neck trauma (fracture, swelling, scar )
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 |
介入・治療 |
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Difficult laryngoscopy (Group D)
Glottic structures appearing during laryngoscopy are graded according to Cormack-Lehane (CL) Classification.
According to this classification, patients are divided into two groups, patients with grade 3-4 are classified as difficult laryngoscopy ( Group D).
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According to Cormack-Lehane (CL) Classification; laryngoscopic view grade 3-4 is defined as Group D
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Easy laryngoscopy (Group E)
Glottic structures appearing during laryngoscopy are graded according to Cormack-Lehane (CL) Classification.
According to this classification, patients are divided into two groups, patients with grade 1-2 are classified as easy laryngoscopy ( Group E).
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According to Cormack-Lehane (CL) Classification; laryngoscopic view grade 1-2 is defined as Group E
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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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Thyromental distance (TMD)
時間枠:1 hour
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The thyromental distance, unit of measure cm, is detected using a US linear probe with the transducer placed in the transverse plane.
Thyromental distance is measured in cm as straight line from thyroid notch to lower border of mentum with head extended in all patients.
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1 hour
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Other airway measurements
時間枠:1 hour
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The other primary objective of this study is to identify if any preanesthetic airway assessment maneuvers (such as mandibula length, the distance between the lip corner and ipsilateral ear tragus, and the transverse length (measured by hand sign-middle-ring fingers adjacent side by side) measurements) would be associated with difficult laryngoscopy in newborn and infants.
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1 hour
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Demographic data
時間枠:1 hour
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The secondary objective of this study is to identify if factors such as age, sex, bady mass index (BMI) and physical status grade would be associated with grade III and IV laryngoscope views in newborn and infants.
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1 hour
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協力者と研究者
捜査官
- 主任研究者:Feyza Sever、Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
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
- 2018105
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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