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Trendelenburg Angle and Upper Airway Ultrasound Findings in Laparoscopic Hysterectomy (TAU-LH)

2026年8月27日 更新者:Izmir City Hospital

Evaluation of the Effect of Trendelenburg Position on Upper Airway Edema by Ultrasonography and Its Relationship With Postoperative Clinical Airway Findings in Patients Undergoing Laparoscopic Hysterectomy

This observational study was designed to evaluate whether the Trendelenburg position used during laparoscopic hysterectomy is associated with swelling of the upper airway.

Women scheduled for elective laparoscopic hysterectomy under general anesthesia were included. During surgery, the angle of the operating table in the Trendelenburg position was measured. The upper airway was assessed with bedside ultrasound by measuring the distance from the skin to the epiglottis and the thickness of the tongue at different time points before and during surgery.

The study did not assign participants to any treatment or intervention. All participants received standard surgical and anesthetic care. After surgery, participants were monitored for early airway-related findings such as noisy breathing after extubation, need for extra oxygen, low oxygen saturation, or need for reintubation.

調査の概要

詳細な説明

Laparoscopic hysterectomy often requires carbon dioxide pneumoperitoneum and Trendelenburg positioning to improve surgical exposure. This position may shift fluid toward the head and neck region and may contribute to swelling of upper airway soft tissues.

This single-center prospective observational study included adult female participants scheduled for elective laparoscopic hysterectomy under general anesthesia. No study-related intervention was assigned. The Trendelenburg angle was determined by the surgical team according to routine clinical need and was recorded using a digital inclinometer.

Upper airway ultrasound measurements were performed at three perioperative time points: before anesthesia induction in the supine position, after Trendelenburg positioning, and at the end of surgery before return to the supine position. The measured ultrasound parameters were distance from skin to epiglottis and tongue thickness.

After extubation, participants were monitored in the post-anesthesia care unit and during the first 24 postoperative hours for clinical airway findings, including postextubation stridor, supplemental oxygen requirement, oxygen saturation below 94% on room air, and reintubation. The study aimed to assess the relationship between Trendelenburg angle, ultrasound-measured upper airway soft tissue changes, and early postoperative clinical airway findings.

研究の種類

観察的

入学 (実際)

68

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

  • 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 female patients scheduled for elective laparoscopic hysterectomy under general anesthesia at Izmir City Hospital, University of Health Sciences, Izmir, Turkey.

説明

Inclusion Criteria:

  • Female patients aged 18 to 65 years
  • Scheduled for elective laparoscopic hysterectomy
  • Planned surgery under general anesthesia
  • American Society of Anesthesiologists physical status I to III
  • Body mass index 35 kg/m² or lower
  • Provided written informed consent for study participation

Exclusion Criteria:

  • Known history of difficult airway or expected difficult airway on preoperative evaluation
  • Mallampati class III or IV
  • Congenital or acquired upper airway pathology
  • Neck mass or previous neck surgery
  • Body mass index greater than 35 kg/m²
  • Pregnancy
  • Emergency surgery
  • Known chronic respiratory disease, such as chronic obstructive pulmonary disease or advanced asthma
  • Upper respiratory tract infection within the previous three weeks
  • Inability to communicate in Turkish
  • Lack of cooperation
  • Conversion to open surgery
  • Requirement for blood transfusion or additional fluid resuscitation beyond the standard protocol
  • Significant hypotension requiring vasopressor support
  • Persistent high peak airway pressures with ventilatory difficulty
  • More than two intubation attempts
  • Withdrawal from the study

Exclusion Criteria:

-

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

コホートと介入

グループ/コホート
介入・治療
Laparoscopic Hysterectomy Cohort
Adult female participants scheduled for elective laparoscopic hysterectomy under general anesthesia. Participants received standard surgical and anesthetic care. No study-related intervention was assigned. Trendelenburg angle was determined according to routine surgical need and recorded during surgery. Upper airway ultrasound measurements were obtained perioperatively, and participants were monitored for postoperative clinical airway findings during the first 24 hours.
Participants underwent elective laparoscopic hysterectomy under general anesthesia as part of standard clinical care. Trendelenburg positioning was applied according to routine surgical need and was not assigned by the study protocol. The Trendelenburg angle was measured and recorded during surgery. Upper airway ultrasound measurements were obtained before and during surgery, and participants were monitored for postoperative clinical airway findings during the first 24 hours.

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
Change in distance from skin to epiglottis
時間枠:From before anesthesia induction to the end of surgery before return to the supine position
Distance from skin to epiglottis was measured using point-of-care upper airway ultrasonography before anesthesia induction, after Trendelenburg positioning, and at the end of surgery before return to the supine position. The outcome was the change from baseline to the end of surgery, expressed in centimeters.
From before anesthesia induction to the end of surgery before return to the supine position

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in tongue thickness
時間枠:From before anesthesia induction to the end of surgery before return to the supine position
Tongue thickness was measured using point-of-care upper airway ultrasonography before anesthesia induction, after Trendelenburg positioning, and at the end of surgery before return to the supine position. The outcome was the change in tongue thickness from baseline to the end of surgery, expressed in centimeters.
From before anesthesia induction to the end of surgery before return to the supine position

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

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2月5日

一次修了 (実際)

2026年5月5日

研究の完了 (実際)

2026年5月5日

試験登録日

最初に提出

2026年8月27日

QC基準を満たした最初の提出物

2026年8月27日

最初の投稿 (実際)

2026年8月31日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月31日

QC基準を満たした最後の更新が送信されました

2026年8月27日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IZMIR-USG-TREND-2026-57
  • 2026/57 (レジストリ識別子:Izmir City Hospital Non-Interventional Clinical Research Ethics Committee)

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?

はい

IPD プランの説明

De-identified individual participant data underlying the results reported in this study may be shared upon reasonable request. Shared data will not include any direct personal identifiers. Access will be subject to approval by the corresponding author and applicable institutional and ethics committee requirements.

IPD 共有時間枠

Data may become available after publication of the main study results and may be available for 5 years after publication.

IPD 共有アクセス基準

Data may be made available to qualified researchers who submit a methodologically sound proposal for scientific purposes related to perioperative airway management, airway ultrasonography, or postoperative airway outcomes. Requests should be directed to the corresponding author. Data sharing will require appropriate institutional and ethics committee approval when applicable.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL

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いいえ

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