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The Role of Ultrasonographic Tracheal Measurements in Predicting Hypoxemia During Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

2026年5月11日 更新者:Ramazan Baldemir、Ankara Ataturk Sanatorium Training and Research Hospital

The Role of Ultrasonographic Tracheal Measurements in Predicting Hypoxemia During Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: A Prospective Observational Study

Bronchoscopic procedures performed under endobronchial ultrasound (EBUS) guidance are widely used minimally invasive diagnostic methods for the evaluation of mediastinal lymph nodes. Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) is an indicated procedure for the diagnosis, staging, and histopathological characterization of primary or metastatic tumors. The procedure is generally performed under moderate or deep sedation to enhance patient comfort and optimize procedural success. Deep sedation has been shown to be a safe and effective approach in terms of respiratory complications in both younger and elderly patients.

However, hypoxemia may develop during EBUS procedures due to mechanisms such as mechanical airway obstruction, sedation-related ventilatory depression, and ventilation-perfusion mismatch. A decrease in oxygen saturation is frequently observed during bronchoscopic procedures, with reported rates of up to 94%. Studies have also reported a hypoxemia rate of approximately 25% during EBUS, even with the use of a nasopharyngeal oxygen cannula. Therefore, maintaining adequate oxygenation throughout the procedure is of critical importance. In patients receiving sedation under spontaneous respiration, oxygen support is typically provided via low-flow systems such as nasal cannulae, which can generally deliver flows of up to 15 L/min.

It has been reported that a fiberoptic bronchoscope occupies approximately 10% of the tracheal cross-sectional area and about 15% at the level of the cricoid ring, leading to partial obstruction. EBUS endoscopes have a larger outer diameter and, in addition, may exert more pronounced negative effects on respiratory mechanics due to the balloon mechanism used. The outer diameter of EBUS bronchoscopes typically ranges between 6.2 and 6.7 mm, mechanically occupying a significant portion of the tracheal lumen. This may restrict tracheal airflow, leading to partial obstruction and consequently predisposing to hypoxemia. Therefore, identifying objective anatomical predictors that can predict the development of hypoxemia is of clinical importance. However, to the best of our knowledge, no study in the literature has statistically investigated the relationship between tracheal measurements and hypoxemia occurring during EBUS.

In this study, the investigators aim to investigate the relationship between pre-procedural tracheal diameter measured by ultrasonography (USG) and the EBUS outer diameter/tracheal diameter ratio (airway occupancy ratio) with the development of hypoxemia during the procedure in patients undergoing EBUS-TBNA. Additionally, it is aimed to determine the optimal tracheal diameter cutoff value that may predict the development of hypoxemia.

Study Design and Patient Population This study will be conducted in accordance with the Declaration of Helsinki and will be carried out at SBÜ Ankara Atatürk Sanatoryum Training and Research Hospital after obtaining approval from the institutional ethics committee. The study is planned as a prospective observational cohort study. Adult patients scheduled to undergo EBUS-TBNA will be included.

The following parameters will be recorded:

  • Age
  • Sex
  • Body mass index (BMI)
  • FEV1 value
  • Baseline SpO₂
  • Lowest recorded SpO₂
  • Systolic/diastolic/mean arterial blood pressure and heart rate measured at 10-minute intervals during the procedure
  • Sedative drug doses
  • Procedure duration
  • Tracheal diameter measured by ultrasonography (USG)
  • Airway occupancy ratio (EBUS outer diameter / narrowest tracheal diameter measured by USG)
  • Duration and total number of hypoxic episodes during the procedure
  • Requirement for airway interventions (jaw thrust, mask ventilation, intubation, etc.)
  • Whether nasal oxygen flow was increased in case of hypoxemia, and if so, by how many L/min
  • Presence of cough, hiccups, secretions requiring aspiration, bronchospasm, and procedure-related bleeding
  • Whether the procedure was interrupted

調査の概要

詳細な説明

H0: There is no significant association between ultrasonographic tracheal measurements and the development of hypoxemia during Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA).

H1: There is a significant association between ultrasonographic tracheal measurements and the development of hypoxemia during Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA).

Ultrasonographic Measurements In this study, tracheal diameter will be measured using a high-frequency linear probe while the patient is in the supine position with the neck in a neutral position. Patients will be instructed to take a deep inspiration, and measurements will be obtained during inspiration at the level just below the cricoid cartilage and at the level of the 2nd-3rd tracheal rings. The narrowest transverse tracheal diameter will be recorded. All ultrasonographic measurements will be performed by the same anesthesiologist.

Sedation Protocol Patients will receive 4 L/min oxygen via nasal cannula along with routine hemodynamic monitoring. Sedation will be administered according to the standard protocol routinely used in our clinic. During the procedure, patients will be maintained under deep sedation corresponding to a Richmond Agitation-Sedation Scale (RASS) score of -4. The total doses of sedative agents used will be recorded.

研究の種類

観察的

入学 (推定)

300

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

研究場所

      • Ankara、トルコ(Türkiye)
        • Ankara Ataturk Sanatorium Training and Research Hospital, Ankara, 06280

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

This study will be conducted in accordance with the Declaration of Helsinki and will be carried out at SBÜ Ankara Atatürk Sanatoryum Training and Research Hospital. In patients aged 18 years and older scheduled to undergo EBUS-TBNA, the narrowest pre-procedural tracheal diameter will be determined. The relationship between tracheal diameter and the development of hypoxemia will be analyzed.

説明

Inclusion Criteria:

  • Patients scheduled for elective EBUS-TBNA
  • Patients who provide written informed consent
  • Patients with ASA physical status I-III
  • Patients aged ≥18 years

Exclusion Criteria:

  • Tracheal stenosis or significant airway obstruction
  • History of tracheostomy
  • Use of home oxygen therapy
  • Pre-procedural SpO₂ < 90% on room air
  • History of prior thoracic surgery
  • Diagnosis of congestive heart failure
  • Presence of pleural effusion
  • FEV1 < 40%
  • COPD patients classified as GOLD stage 3-4
  • Restrictive lung disease (FVC < 50%)
  • Advanced pulmonary hypertension
  • History of surgery affecting neck anatomy
  • Tracheal deviation due to large thyroid or mediastinal mass
  • ASA physical status IV
  • Pregnancy
  • EBUS performed under general anesthesia (with endotracheal intubation or laryngeal mask airway)
  • Hemodynamic instability

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
Adult patients scheduled to undergo EBUS-TBNA
"In patients aged 18 years and older scheduled to undergo EBUS-TBNA, the narrowest pre-procedural tracheal diameter will be determined. The relationship between tracheal diameter and the development of hypoxemia will be analyzed.
"In patients aged 18 years and older scheduled to undergo EBUS-TBNA, the narrowest pre-procedural tracheal diameter will be determined. The relationship between tracheal diameter and the development of hypoxemia will be analyzed.

Hypoxemia will be defined as the presence of at least one of the following criteria:

  • SpO₂ < 90% for at least 10 seconds, or
  • A decrease in SpO₂ of ≥5% from baseline

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
時間枠
Hypoxemia
時間枠:Periprocedural
Periprocedural

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

  • 主任研究者:Ramazan BALDEMİR、Ankara Ataturk Sanatorium Training and Research Hospital

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5月20日

一次修了 (推定)

2027年5月1日

研究の完了 (推定)

2027年5月1日

試験登録日

最初に提出

2026年4月27日

QC基準を満たした最初の提出物

2026年5月11日

最初の投稿 (実際)

2026年5月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月14日

QC基準を満たした最後の更新が送信されました

2026年5月11日

最終確認日

2026年5月1日

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