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OpenTrials
Completed

NCT Number: NCT06908109

This Study Will Evaluate the Effectiveness of a Simple Intervention Through a Classical Yankauer Oral Suction Tube, in Decreasing the Sedative Medication Doses Needed to Provide Effective Patient Sedation During Bronchoscopy, Along With Its Effect on Both Patient's and Bronchoscopist Satisfaction

The aim of this study is to evaluate the effectiveness of a simple intervention through a classical Yankauer oral suction tube, a device known to have a proven safety profile in multiple healthcare settings, in decreasing the sedative and opioid medication doses needed to provide effective patient sedation during bronchoscopy, along with its effect on both patient's and bronchscopist's satisfaction throughout the procedure.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or above
  • inpatients or outpatients
  • scheduled to have a flexible bronchoscopy for one of multiple indications based on their physician's assessment, including the presence of a lung mass or collapse, persistent pulmonary infiltrates, pulmonary infection in the setting of immunosuppression, hemoptysis, or other rare causes like chronic cough.
  • patients provided a written informed consent.

Exclusion criteria

  • patients with anatomic oro-pharyngeal abnormalities,
  • critically ill patients
  • uncooperative patients or inability to provide signed consent by the patient or their legal representative
  • coagulopathy or bleeding diathesis
  • severe obstructive airway disease
  • recent myocardial infarction
  • uncontrolled or poorly controlled asthma or chronic obstructive pulmonary disease (COPD)
  • pregnancy.

Treatment and study plan

Yankauer Suction Device

Device

The Yankauer suction device is a hollow, curved and flexible tube that has a suction tip surrounded by a bulbous head to allow effective suctioning without damaging the surrounding tissue. It has been frequently used in multiple settings that range from minor dental procedures to large surgeries. It is also frequently used in the intensive care units to suction oropharyngeal secretions and prevent aspiration. Throughout this study, and regardless of the study group (control or intervention group), the Yankauer suction device is attached to a distinct suction port and placed, at the other end, inside the oral cavity of the patient.

Bronchoscopy

Procedure

Flexible bronchoscopy done for the following indications: presence of a lung mass or collapse, persistent pulmonary infiltrates, pulmonary infection in the setting of immunosuppression, hemoptysis, or other rare causes like chronic cough. Flexible bronchoscopy (FB) is a medical procedure that has been used for more than five decades for the diagnostic evaluation and/or therapeutic intervention in a multitude of pulmonary and bronchial diseases

Primary outcomes

  1. Mean doses of Midazolam and Fentanyl

    Time frame: From enrollment (pre-bronchoscopy) to the end of the bronchoscopic procedure (up to 30 minutes)

    From the time of enrollment (pre-bronchoscopy) to the end of the bronchoscopic procedure

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

Continuous Oral Suctioning During Flexible Bronchoscopy: Effect on Sedative Medication Needs and Both Endoscopist's and Patient's Satisfaction

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 3, 2025
Registry last updated
Apr 4, 2025

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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