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Effect of Head and Neck Positioning on Awake Fiberoptic Intubation in Obese Patients

2026年11月4日 更新者:Amr Raafat Mahmoud Seif、Cairo University

Effect of Head and Neck Positioning on Awake Fiberoptic Intubation in Obese Patients: A Randomized Controlled Study

The aim of the study was the assessment and comparison of the time taken for vocal cord visualization with three different head positions: (conventional sniffing position, ramp position and supine position) in obese patients

調査の概要

詳細な説明

Airway management in patients undergoing general anesthesia is a set of actions that result in the creation of a safe and secure airway for ventilation. Failure in airway management and hypoxia can lead to irreversible brain damages within only a few minutes .

The prevalence of obesity is rising worldwide, and this is a challenge for specialists in various fields of medicine. There is an inverse correlation between body weight and pharyngeal space. This association is significant because excess fat in morbid obesity can influence the pharyngeal spaces, and thus, significantly change laryngoscopic grade . Overall, airway management in obese patients can pose numerous challenges as these patients are at a higher risk for difficult airway than normal patients . In fact, patients with morbid obesity have excess fat in the mouth, neck, pharynx, thorax, breast, and abdomen, making access to the airway more problematic in various anesthesia situations such as intubation, tracheostomy, or mask ventilation as compared to normal subjects. In most studies, an increase in neck circumference was associated with difficult intubation, and a neck circumference over 60 cm was linked with a 35% likelihood of difficult intubation. Hence, the possibility of difficult intubation and problems with difficult airways in these patients should be considered, and a solution should be provided. In dealing with difficult airways, assistive devices such as fiberoptic bronchoscope and video-laryngoscope may be used in either awake or anesthetized patients .

Proper positioning before the induction of anesthesia is a key step in successful intubation . Numerous studies have emphasized the significance of head and neck positioning, which can have a significant impact on successful intubation and reduce tracheal injury and post-intubation complications .

The aim of the study was the assessment and comparison of the time taken for vocal cord visualization with three different head positions: (conventional sniffing position, ramp position and supine position) in obese patients

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~60年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Age between 18 to 60 years old
  • Body mass index more than 40 kg/m
  • Potentially difficult intubation defined as mallampatti classification greater than two and neck circumference more than 40 cm

Exclusion Criteria:

  • Age younger than 18 and more than 60 years old
  • American Society of Anesthesiologists clinical status is more than four
  • Sever mental disorder (psychotic or consider incapable of understanding the information)
  • Mouth opening is less than 15 mm
  • Poor dental status
  • Contraindication to any drug used in the study
  • patient refusal.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Group (S) Sniffing position

Group (S) Sniffing position : All patients will be explained the procedure on the day of surgery. Intravenous access will be gained a 16 through gauge cannula under local anesthesia. Standard monitoring (pulse oximeter, electrocardiography, non-invasive blood pressure) will attach to the patients. The patient's airway will be anesthetized using aerosolized lignocaine 2%.

The oral and pharyngeal reflexes will be blunted by anesthetizing oral and pharyngeal mucosa with 10% lignocaine spray and gargles.

Group (S) : patients will be explained the procedure on the day of surgery. Intravenous access will be gained a 16 through gauge cannula under local anesthesia. Standard monitoring (pulse oximeter, electrocardiography, non-invasive blood pressure) will attach to the patients. The patient's airway will be anesthetized using aerosolized lignocaine 2%.

The oral and pharyngeal reflexes will be blunted by anesthetizing oral and pharyngeal mucosa with 10% lignocaine spray and gargles. The sniffing position will be made by placing 8 cm ring pillow under the patient head so that it will be tilted. The external auditory meatus will be aligned the sterna notch in the horizontal plane. The elevation of the operating and position of the anesthesiologist will be adjusted to ensure that the fiber-optic will be kept straight as it entered the patient's nasal cavity. The appropriate-sized endotracheal tube will be loaded over a 5mm external diameter flexible fiberoptic bronchoscope. Preoxygenation w

実験的:Group (R) Ramped position

Group (R) Ramped position: patients will be explained the process. Intravenous access will be gained and standard monitoring will be attached to the patients. The patient's airway will be anesthetized. After this, the patients will be helped to assume a ramped position. Three soft pillows will be positioned beneath the patient's head and upper body so that the external auditory meatus will be in a horizontal plane with a sternal notch.

Group (R) Ramped position On the day of the operation, all Group R patients will be explained the process. Intravenous access will be gained and standard monitoring will be attached to the patients. The patient's airway will be anesthetized. After this, the patients will be helped to assume a ramped position. Three soft pillows will be positioned beneath the patient's head and upper body so that the external auditory meatus will be in a horizontal plane with a sternal notch. The elevation of the operating and position of the anesthesiologist will be adjusted to ensure that the fiber-optic was straight as it entered the patient's nasal cavity. An appropriately sized endotracheal tube will be loaded over a 5mm external diameter flexible fiberoptic bronchoscope. Preoxygenation will be performed with 100% oxygen with tidal volume ventilation for three to five minutes to achieve an end-expiratory oxygen concentration greater than 90%.

実験的:Group (SU) Supine position

Group (SU) Supine position: All Group SU patients were explained the procedure on the day of surgery. Intravenous access was gained through a 16-gauge cannula under local anesthesia. Standard monitoring (pulse oximeter, electrocardiography, non-invasive blood pressure) was attached to the patients. The patient's airway was anesthetized using aerosolized lignocaine 2%. The oral and pharyngeal reflexes were blunted by anesthetizing oral and pharyngeal mucosa with 10% lignocaine spray and gargles.

Group (SU) Supine position: patients were explained the procedure on the day of surgery. Intravenous access was gained through a 16-gauge cannula under local anesthesia. Standard monitoring (pulse oximeter, electrocardiography, non-invasive blood pressure) was attached to the patients. The patient's airway was anesthetized using aerosolized lignocaine 2%. The oral and pharyngeal reflexes were blunted by anesthetizing oral and pharyngeal mucosa with 10% lignocaine spray and gargles. The elevation of the operating and position of the anesthesiologist will be adjusted to ensure that the fiber-optic was kept straight as it entered the patient's nasal cavity. The appropriate-sized endotracheal tube will be loaded over a 5mm external diameter flexible fiberoptic bronchoscope. Preoxygenation will be performed with 100% oxygen with tidal volume ventilation for three to five minutes to achieve an end- expiratory oxygen concentration greater than 90%.

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
comparison of the time taken for vocal cord visualization
時間枠:1 hour

Assessment and comparison of the time taken for vocal cord visualization with three different head positions: (conventional sniffing position, ramp position and supine position) in obese patients.

1 hour

二次結果の測定

結果測定
メジャーの説明
時間枠
Cough score for fiberoptic and for intubation
時間枠:1 hour

Cough score for fiberoptic and for intubation (score range: 0 = none, 1 = slight, 2 = moderate, 3 = severe)

1 hour

協力者と研究者

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年9月30日

一次修了 (推定)

2027年9月30日

研究の完了 (推定)

2027年9月30日

試験登録日

最初に提出

2026年11月4日

QC基準を満たした最初の提出物

2026年11月4日

最初の投稿 (実際)

2026年11月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月10日

QC基準を満たした最後の更新が送信されました

2026年11月4日

最終確認日

2026年9月1日

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IPD プランの説明

It will be available if it needed

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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