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

NCT06908109 | Completed DMC

• 1 other identifier: IM.IBA.03
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Sham Group

SHAM COMPARATOR

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

Yankauer group

ACTIVE COMPARATOR

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

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.

Yankauer group

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

Sham Group; Yankauer group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 3, 2025
• Study Start: March 4, 2016
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share