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Completed

NCT Number: NCT05425836

HFNC Versus SOT During EBUS

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) is a routine procedure that is performed to sample mediastinal lymph nodes. At author's center the EBUS-TBNA procedure is performed under conscious sedation using midazolam. During the EBUS procedure, oxygen supplementation can either be provided using low flow or high flow through a nasal cannula.

The investigators hypothesize that the use of high flow nasal cannula (HFNC) for oxygen supplementation during EBUS would be associated with lesser incidence of clinically significant hypoxemia (SpO2 ≤90%) when compared to conventional nasal cannula. In this study, the authors plan to assess the efficacy of HFNC in reducing the incidence of hypoxemic events in subjects undergoing EBUS under conscious sedation.

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Key information

Conditions

Endobronchial Ultrasound

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bronchoscopy suite, Chandigarh, India

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About this study

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) is a routine procedure that is performed to sample mediastinal lymph nodes. The procedure is performed either under conscious sedation or using general anaesthesia. At author's center the EBUS-TBNA procedure is performed under conscious sedation using midazolam.During the EBUS procedure, oxygen supplementation is provided to prevent desaturation events. However, despite oxygen supplementation previous studies have reported fall in pulse oximetric saturation (SpO2) below 90%.

The high-flow nasal cannula (HFNC) is a novel device for providing oxygen supplementation. It delivers a flow of 10-70 litres/min of humidified, warmed 100% oxygen through a nasal cannula. The device has been used extensively in intensive care setting in adults with hypoxemic respiratory failure. In a study conducted on patients undergoing EBUS-TBNA, the use of HFNC led to a significant reduction in the number of subjects experiencing clinically significant hypoxemia (SpO2 ≤90%) compared to conventional oxygen supplementation. However, the study conclusions were limited by a small sample size. Another study demonstrated lesser episodes of hypoxemia with HFNC compared to the conventional oxygen supplementation. This study also had a small sample size (n=40). The investigators that the use of HFNC for oxygen supplementation during EBUS would be associated with lesser incidence of clinically significant hypoxemia (SpO2 ≤90%) when compared to conventional nasal cannula. In this study, the authors intend to assess the efficacy of HFNC in reducing the incidence of hypoxemic events in subjects undergoing EBUS under conscious sedation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adult (aged between 18 and 80 years) subjects undergoing the EBUS-TBNA procedure and pulse oximetric SPO2 ≥95% at room air will be eligible for this study

Exclusion criteria

  • oxygen supplementation required to achieve SPO2 >95%;
  • subjects who have altered mentation;
  • pregnancy
  • failure to provide informed consent

Treatment and study plan

Standard oxygen therapy

Device

nasal cannula

HFNC

Device

High flow nasal cannula

Primary outcomes

  1. proportion of subjects experiencing oxygen desaturation events

    Time frame: 1 hour (during the EBUS procedure)

    oxygen desaturation events (defined SpO2 <90% for at least 10 seconds) during the EBUS-TBNA procedure

Secondary outcomes

  1. SPO2 after pre-oxygenation

    Time frame: 1 hour (during the EBUS procedure)

    Pre-oxygenation for 5 minutes before sedation

  2. number of desaturation events (SPO2 <90% for at least 10 seconds) during the procedure

    Time frame: 1 hour (during the EBUS procedure)

    Desaturation events will defined as SPO2 <90% for at least 10 seconds

  3. nadir SPO2 level during the procedure

    Time frame: 1 hour (during the EBUS procedure)

    lowest oxygen saturation

  4. patient comfort and bronchoscopist satisfaction score

    Time frame: 1 hour (during the EBUS procedure)

    assessed on a visual analogue scale (VAS); VAS will be measured on a scale of 0 to 100 mm, 0 being very comfortable or satisfied and 100 being extremely uncomfortable or unsatisfied

  5. number of participants experiencing complications in each group

    Time frame: 1 hour (during the EBUS procedure)

    cardiac arrhythmia, hypotension, escalation of the level of care (hospitalization, airway intubation need for non-invasive or invasive mechanical ventilation), altered mentation, respiratory failure or cardiac arrest

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

A Randomized Controlled Trial to Compare High Flow Nasal Cannula With Standard Nasal Cannula to Prevent Desaturation in Subjects Undergoing Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)

Acronym: NOT-EBUS

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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