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

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

Study Overview

• Status: Completed
• Conditions: Bronchoscopy
• Intervention / Treatment: Device: Yankauer Suction Device; Procedure: Bronchoscopy

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Procedure: Bronchoscopy; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean doses of Midazolam and Fentanyl	From the time of enrollment (pre-bronchoscopy) to the end of the bronchoscopic procedure	From enrollment (pre-bronchoscopy) to the end of the bronchoscopic procedure (up to 30 minutes)

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2016
• Primary Completion (Actual): October 14, 2022
• Study Completion (Actual): October 14, 2022

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IM.IBA.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No