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

American University of Beirut Medical Center

Status: Completed

Conditions: Bronchoscopy

Treatments: Device: Yankauer Suction Device; Procedure: Bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06908109

IM.IBA.03

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Sham Group

Sham Comparator group

Description:

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.

Treatment:

Procedure: Bronchoscopy

Yankauer group

Active Comparator group

Description:

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.

Treatment:

Procedure: Bronchoscopy

Device: Yankauer Suction Device