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気管内カフ膨張における喉頭浮腫に対する 2 つの方法の効果の比較

2026年9月17日 更新者:Mustafa Berkehan Nizamlıoğlu、Fatih Sultan Mehmet Training and Research Hospital

USGによる腰椎安定化手術を受けた患者の周術期喉頭浮腫の評価における従来の測定方法とマノメトリー測定方法の比較

In this study, the investigators aimed to evaluate perioperative laryngeal edema in patients undergoing lumbar stabilization surgery in the pron position, which the investigators use in our routine anesthesia practice, by using conventional and manometry measurement methods and ultrasonography, which the investigators also use frequently in our routine, and to evaluate complications related to laryngeal edema in postoperative service follow-up.

調査の概要

詳細な説明

Lumbar spine surgery is commonly performed in the prone position. Although the prone position provides optimal surgical exposure, it may be associated with several physiological and position-related complications. Increased intra-abdominal and intrathoracic pressures may affect venous return and hemodynamics, while compression of the face, neck, and upper airway may contribute to facial and laryngeal edema. In addition, displacement, obstruction, or kinking of the endotracheal tube may occur after positioning.

Endotracheal tube cuff pressure represents another potential contributor to airway morbidity. The recommended cuff pressure is generally 25-30 cmH₂O. Excessive cuff pressure may impair tracheal mucosal perfusion and contribute to mucosal injury and postoperative airway symptoms. In conventional clinical practice, cuff inflation is often performed by manual palpation of the pilot balloon, whereas cuff manometry allows objective measurement and adjustment of cuff pressure.

Ultrasonographic measurement of laryngeal air column width (ACW) provides a non-invasive method for assessing peri-extubation changes in the upper airway. In this study, ACW is measured after tracheal intubation and again before extubation, and the pre-extubation/post-intubation ACW ratio is used to assess perioperative changes suggestive of laryngeal edema.

This prospective observational study evaluates peri-extubation laryngeal edema in adult patients undergoing elective lumbar stabilization surgery in the prone position at Fatih Sultan Mehmet Training and Research Hospital. Participants are categorized according to the endotracheal tube cuff inflation technique used as part of routine anesthetic care: conventional pilot balloon palpation (Conventional group) or manometer-guided cuff inflation (Manometer group). No study-specific random allocation is performed, and the cuff inflation technique is determined as part of routine anesthetic practice rather than by the research protocol.

After standard monitoring and induction of general anesthesia, patients are intubated by direct laryngoscopy using an appropriately sized reinforced orotracheal tube. In the Conventional group, the endotracheal tube cuff is inflated manually according to the attending anesthesiologist's routine clinical practice, after which cuff pressure is measured using a cuff manometer and recorded. In the Manometer group, cuff pressure is adjusted to 25-30 cmH₂O using a cuff manometer. Thereafter, cuff pressure is measured and recorded at 30-minute intervals throughout the operation in both groups. In the Conventional group, cuff pressure is measured and recorded at these intervals without protocol-driven adjustment, whereas in the Manometer group, cuff pressure is readjusted to 25-30 cmH₂O when necessary.

Following intubation, laryngeal ACW is measured ultrasonographically in the transverse plane at the level of the cricothyroid membrane using a linear transducer. Patients are subsequently positioned prone with particular attention to avoiding pressure on the eyes, face, and neck. Mechanical ventilation is provided using volume-controlled ventilation with a tidal volume of 8 mL/kg, positive end-expiratory pressure of 5 cmH₂O, and a respiratory rate adjusted to maintain end-tidal carbon dioxide between 35 and 40 mmHg. General anesthesia is maintained with desflurane and remifentanil, with anesthetic agents titrated according to hemodynamic parameters and Patient State Index values. Routine hemodynamic and respiratory parameters are monitored and recorded throughout the procedure.

At the end of surgery, patients are returned to the supine position. Before extubation, laryngeal ACW is measured again using the same ultrasonographic technique. For ACW measurements, oral secretions are aspirated and the endotracheal tube cuff is deflated. After measurement, the cuff is reinflated to the appropriate pressure using a cuff manometer. The ACW ratio is calculated as the pre-extubation ACW divided by the post-intubation ACW.

After recovery from neuromuscular blockade and fulfillment of standard extubation criteria, patients are extubated and transferred to the post-anesthesia care unit. Postoperative airway-related symptoms, including cough, dyspnea, dysphagia, dysphonia, sore throat, and facial edema, are assessed during postoperative follow-up at 4, 8, and 24 hours after surgery.

研究の種類

観察的

入学 (実際)

62

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

    • Atasehir
      • Istanbul、Atasehir、トルコ(Türkiye)、34752
        • Fatih Sultan Mehmet Training and Research Hospital

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~65年 (大人、高齢者)

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

サンプリング方法

非確率サンプル

調査対象母集団

Adult patients aged 18-65 years with ASA physical status I-III undergoing elective lumbar stabilization surgery under general anesthesia in the prone position at Fatih Sultan Mehmet Training and Research Hospital. Eligible patients were prospectively enrolled according to the predefined inclusion and exclusion criteria. Participants were categorized according to the endotracheal tube cuff management technique used as part of routine anesthetic care (conventional pilot balloon palpation or manometer-guided cuff management); no study-specific random allocation was performed.

説明

Inclusion Criteria:

  • Patients who will undergo lumbar spinal surgery under general anesthesia under elective conditions
  • Patients aged 18-65 years, included in the ASA I-III group
  • Patients whose consent has been obtained

Exclusion Criteria:

  • Patients under 18 years of age, over 65 years of age, included in the ASA IV-V group
  • Patients with a history of surgery in the oral cavity, including direct laryngoscopy and biopsy, microlaryngoscopic surgery, tonsillectomy, adenoidectomy, soft palate, oropharynx, hypopharynx, larynx and trachea,
  • Patients with a history of allergies, asthma, reflux, upper respiratory viral or fungal infections and cancer surgeries,
  • Patients receiving radiotherapy to the neck who had multiple intubation attempts in the previous year,
  • Patients undergoing emergency surgery,
  • Patients with advanced cardiac, renal, pulmonary and hepatic failure,
  • Patients who did not give consent to participate in the study.

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

  • 観測モデル:COHORT
  • 時間の展望:PROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
Conventional

The endotracheal tube cuff was manually inflated according to the attending anesthesiologist's routine clinical practice. The initial cuff pressure was subsequently measured using a cuff manometer and recorded. During surgery, cuff pressure was measured and recorded at 30-minute intervals without protocol-driven adjustment.

The endotracheal tube cuff was manually inflated according to the attending anesthesiologist's routine clinical practice. The initial cuff pressure was subsequently measured using a cuff manometer and recorded. During surgery, cuff pressure was measured and recorded at 30-minute intervals without protocol-driven adjustment. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol.

Manometer

The endotracheal tube cuff pressure was initially adjusted to 25-30 cmH₂O using a cuff manometer. During surgery, cuff pressure was measured and recorded at 30-minute intervals and was readjusted to 25-30 cmH₂O when necessary. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol.

The endotracheal tube cuff pressure was initially adjusted to 25-30 cmH₂O using a cuff manometer. During surgery, cuff pressure was measured and recorded at 30-minute intervals and was readjusted to 25-30 cmH₂O when necessary. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol.

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
Measurement of airway column width
時間枠:through study completion, an average of 6 months

Measurement of the effect of conventional and manometry methods on air column width by ultrasonography. With ultrasonography, laryngeal edema development can be observed in patients by measuring the air column width after intubation and before extubation in the transverse axis with a linear probe over the patient's cricothyroid membrane

through study completion, an average of 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Detection of complications due to postoperative laryngeal edema
時間枠:It will be evaluated at PACU 5th minute and postoperative 4, 8, 24th hours

Detection of cough, dyspnea, dysphagia, dysphonia, dysphonia, facial edema that may occur after surgery for laryngeal edema.

It will be evaluated at PACU 5th minute and postoperative 4, 8, 24th hours

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • スタディディレクター:Arzu Yildirim Ar, As Prof、Fatih Sultan Mehmet Training and Research Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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)

2025年2月1日

一次修了 (実際)

2025年6月30日

研究の完了 (実際)

2025年7月10日

試験登録日

最初に提出

2024年12月28日

QC基準を満たした最初の提出物

2025年1月7日

最初の投稿 (実際)

2025年1月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月22日

QC基準を満たした最後の更新が送信されました

2026年9月17日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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