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

11 de maio de 2026 atualizado por: 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

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

300

Contactos e Locais

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Contato de estudo

Locais de estudo

      • Ankara, Turquia (Türkiye)
        • Ankara Ataturk Sanatorium Training and Research Hospital, Ankara, 06280

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Hypoxemia
Prazo: Periprocedural
Periprocedural

Colaboradores e Investigadores

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Investigadores

  • Investigador principal: Ramazan BALDEMİR, Ankara Ataturk Sanatorium Training and Research Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

20 de maio de 2026

Conclusão Primária (Estimado)

1 de maio de 2027

Conclusão do estudo (Estimado)

1 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

27 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de maio de 2026

Primeira postagem (Real)

14 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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