このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。英語版ソーステキスト用。

Direct Versus Video Laryngoscopy in Patients With Acromegaly (ACRO-VL)

2026年6月17日更新者：Muzaffer GENCER

Determination of the Appropriate Intubation Method in Patients With Acromegaly: Comparison of Direct Laryngoscopy and Video Laryngoscopy

Acromegaly is associated with craniofacial skeletal changes and upper airway soft tissue hypertrophy, which may increase the risk of difficult laryngoscopy and tracheal intubation. This prospective observational study aims to evaluate airway and intubation characteristics in patients with acromegaly undergoing surgery under general anesthesia and to compare direct laryngoscopy and video laryngoscopy findings.

Adult patients with acromegaly and patients with nonfunctioning pituitary adenomas scheduled for surgery under general anesthesia will be prospectively enrolled between July 1, 2026, and August 31, 2026. Preoperative airway assessment parameters, hormonal data including growth hormone and insulin-like growth factor-1 levels, Mallampati score, modified Cormack-Lehane grade, intubation-related variables, and peri-intubation complications will be recorded.

調査の概要

状態

まだ募集していません

条件

詳細な説明

This prospective observational study will be conducted at Basaksehir Cam and Sakura City Hospital between July 1, 2026, and August 31, 2026. The study population will include adult patients with acromegaly and adult patients with nonfunctioning pituitary adenomas who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.

Eligible patients will undergo routine preoperative airway assessment. Recorded variables will include age, sex, height, body weight, body mass index, history of obstructive sleep apnea syndrome, comorbid diseases, previous operations, presence of hypopituitarism, preoperative growth hormone level, preoperative insulin-like growth factor-1 level, IGF-1 index, Mallampati score, and other airway-related clinical parameters.

During airway management, laryngoscopic findings obtained with direct laryngoscopy and video laryngoscopy will be recorded. The modified Cormack-Lehane classification will be used to assess glottic visualization. Intubation-related variables, including first-attempt success, time to successful intubation, number of intubation attempts, need for adjunct airway maneuvers or devices, oxygen desaturation, and airway trauma, will also be documented.

The primary objective of the study is to compare laryngoscopic findings and intubation characteristics in patients with acromegaly and to evaluate whether video laryngoscopy provides advantages over direct laryngoscopy in this patient group. The secondary objective is to identify clinical, hormonal, and airway-related predictors of difficult laryngoscopy or difficult intubation in patients with acromegaly.

研究の種類

観察的

入学 (推定)

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。

研究連絡先

名前：Muzaffer Gencer, associate professor
電話番号：+90 212 909 60 00
メール：dr.m.gencer07@gmail.com

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

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

Adult patients with acromegaly or nonfunctioning pituitary adenoma who are evaluated by the institutional pituitary diseases council and scheduled for elective surgery under general anesthesia requiring endotracheal intubation at Basaksehir Cam and Sakura City Hospital.

説明

Inclusion Criteria:

Age 18 years or older
Diagnosis of acromegaly and scheduled for surgery after evaluation by the institutional pituitary diseases council
Diagnosis of nonfunctioning pituitary adenoma and scheduled for surgery after evaluation by the institutional pituitary diseases council
Requirement for general anesthesia with endotracheal intubation
Ability and willingness to provide written informed consent

Exclusion Criteria:

Age younger than 18 years
Refusal to participate in the study
Presence of extrapituitary malignancy
Emergency surgery
Previous tracheostomy or major laryngeal/tracheal surgery
Severe limitation of mouth opening preventing standard laryngoscopic evaluation
Cervical spine instability or severe restriction of neck extension
Patients requiring awake fiberoptic intubation according to preoperative airway assessment
Patients for whom participation is considered unsafe by the responsible anesthesiologist

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

グループ/コホートの数

コホートと介入

グループ/コホート
Acromegaly Group Adult patients diagnosed with acromegaly who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.
Nonfunctioning Pituitary Adenoma Group Adult patients diagnosed with nonfunctioning pituitary adenoma who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.

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
Modified Cormack-Lehane Grade With Direct and Video Laryngoscopy 時間枠：During tracheal intubation procedure	The modified Cormack-Lehane grade obtained during direct laryngoscopy and video laryngoscopy will be recorded and compared to evaluate glottic visualization and the degree of laryngoscopic difficulty.	During tracheal intubation procedure

二次結果の測定

結果測定	メジャーの説明	時間枠
Mallampati Classification Score 時間枠：Preoperative airway assessment before induction of anesthesia	The preoperative Mallampati Classification score will be recorded as part of the routine airway assessment and evaluated for its association with difficult laryngoscopy or difficult intubation. The Mallampati Classification ranges from Class I to Class IV, with a minimum value of Class I and a maximum value of Class IV. Higher scores indicate poorer visualization of the oropharyngeal structures and a worse airway assessment, reflecting a greater likelihood of difficult laryngoscopy or difficult intubation.	Preoperative airway assessment before induction of anesthesia
Time to Successful Intubation 時間枠：During tracheal intubation procedure	Time to successful intubation will be defined as the time, measured in seconds, from insertion of the laryngoscope into the oral cavity to confirmation of endotracheal tube placement by capnography.	During tracheal intubation procedure
Number of Intubation Attempts 時間枠：During tracheal intubation procedure	The total number of laryngoscopy attempts required for successful endotracheal intubation will be recorded. An intubation attempt will be defined as each insertion of the laryngoscope into the oral cavity with the intention of endotracheal tube placement.	During tracheal intubation procedure
Need for Adjunct Airway Maneuvers or Devices 時間枠：From induction of anesthesia until confirmation of successful endotracheal tube placement by capnography during the airway management procedure	The need for adjunct airway maneuvers or devices will be recorded as a binary outcome, defined as whether any additional airway maneuver or device is required to achieve successful endotracheal intubation. Adjuncts may include external laryngeal manipulation, stylet, bougie, change of laryngoscope, supraglottic airway device, or fiberoptic bronchoscopy.	From induction of anesthesia until confirmation of successful endotracheal tube placement by capnography during the airway management procedure
Peri-Intubation Oxygen Desaturation 時間枠：From anesthesia induction to 5 minutes after intubation	Peri-intubation oxygen desaturation will be defined as a decrease in peripheral oxygen saturation below 90% during airway management.	From anesthesia induction to 5 minutes after intubation
Airway Trauma 時間枠：Immediately after intubation	Airway trauma will be assessed by the presence of mucosal bleeding, dental trauma, lip injury, or other visible airway-related injury after intubation.	Immediately after intubation
Association Between Growth Hormone Level and Difficult Laryngoscopy 時間枠：Baseline preoperative assessment and during the tracheal intubation procedure	Preoperative growth hormone levels will be recorded and analyzed for their association with the modified Cormack-Lehane grade and difficult laryngoscopy. Difficult laryngoscopy will be assessed during tracheal intubation based on the modified Cormack-Lehane grade.	Baseline preoperative assessment and during the tracheal intubation procedure
Association Between Insulin-Like Growth Factor 1 Level and Difficult Laryngoscopy 時間枠：Preoperative baseline assessment and during the tracheal intubation procedure	Preoperative insulin-like growth factor 1 levels and insulin-like growth factor 1 index will be recorded and analyzed for their association with the modified Cormack-Lehane grade and difficult laryngoscopy. Difficult laryngoscopy will be assessed during tracheal intubation based on the modified Cormack-Lehane grade.	Preoperative baseline assessment and during the tracheal intubation procedure

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。

スポンサー

Muzaffer GENCER

協力者

Başakşehir Çam & Sakura City 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 (推定)

2026年7月1日

一次修了 (推定)

2026年8月31日

研究の完了 (推定)

2026年8月31日

試験登録日

最初に提出

2026年6月13日

QC基準を満たした最初の提出物

2026年6月17日

最初の投稿 (実際)

2026年6月22日

学習記録の更新

投稿された最後の更新 (実際)