CClinicalTrials.gg
CompletedNCT06908109Updated Apr 4, 2025

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

An interventional study of Yankauer Suction Device and Bronchoscopy in Bronchoscopy, sponsored by American University of Beirut Medical Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by American University of Beirut Medical Center · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 9 years after the study started (first participant enrolled Mar 2016, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Bronchoscopy
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In context

Lead sponsor

American University of Beirut Medical Center is the lead sponsor of 152 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
120 participants (actual)

Study arms

  • Sham comparator
    Sham Group

    The control group: included another 60 patients, who underwent the regular FB procedure with a blinded defective Yankauer suction device (Sham) attached to the oral cavity of the patient and present throughout the procedure.

    Procedure: Bronchoscopy

  • Active comparator
    Yankauer group

    The intervention group: included 60 patients, who underwent the regular FB procedure with a functional standard Yankauer suction device attached to the oral cavity of the patient and present throughout all the procedure.

    Device: Yankauer Suction Device · Procedure: Bronchoscopy

Interventions

  • DeviceYankauer Suction 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.

  • ProcedureBronchoscopy

    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

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What researchers measure

Primary outcomes

  1. Mean doses of Midazolam and Fentanyl

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

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06908109
Lead sponsor
American University of Beirut Medical Center
Responsible party
Rayan Mohamad (Clinical Associate, American University of Beirut Medical Center) — Principal investigator
First posted
Apr 3, 2025
Start date
Mar 4, 2016
Primary completion
Oct 14, 2022
Completion
Oct 14, 2022
Last update
Apr 4, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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