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Completed

NCT Number: NCT04686656

Nasal Versus Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

The purpose of this study is to compare to nasal and buccal oxygen administration in patients undergoing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration .

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Key information

Conditions

Lung Diseases Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Training and Researching Hospital

Antalya, Turkey (Türkiye)

About this study

Anesthesia for Endobronchial Ultrasound (EBUS) may be range from routine bronchoscopy sedation to general anesthesia. During sedation to EBUS increased duration of anesthesia and sedative dosing put patients at increased risk for hypoxic events. To avoid this, oxygen supplementation is mandatory. There are different techniques for oxygen supplementation during the procedure. At this study we will compare to nasal and buccal oxygen supplementations during EBUS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients ≥18 years of age
  • body mass index (BMI) between 20 and 30
  • American Society of Anesthesiologists physical status I-III

Exclusion criteria

  • congestive heart failure
  • ischemic heart disease
  • increased intracranial pressure
  • known allergy or contraindication to study drugs (propofol, fentanyl, or midazolam)
  • an anatomical feature precluding adequate positioning of the buccal device.

Treatment and study plan

nasal oxygen

Other

Nasal cannula will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with nasal cannula.

buccal oxygen

Other

Ring-adair-elwyn (RAE) tube will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with RAE tube.

Primary outcomes

  1. hypoxia-related interruptions

    Time frame: 30 minutes

    the number of hypoxia-related interruptions

Secondary outcomes

  1. duration of procedure

    Time frame: 30 minutes

    Duration of procedure will be defined in minute as the time from starting to insert EBUS device until the time to remove the device

  2. use of propofol

    Time frame: 30 minutes

    The use of amount of propofol will be noted during the procedure.

  3. use of fentanyl

    Time frame: 30 minutes

    The use of amount of fentanyl will be noted during the procedure.

  4. satisfaction of pulmonary specialist

    Time frame: 30 minutes

    satisfaction of pulmonary specialist will be evaluated by 4-points Likert Scale

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

A Randomized Controlled Trial Comparing Nasal With Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2020
Registry last updated
Apr 8, 2021

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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