Continuous Oral Suctioning During Flexible Bronchoscopy: Effect on Sedative Medication Needs and Both Endoscopist's and Patient's Satisfaction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Primary Endpoint
- Mean doses of Midazolam and Fentanyl
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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.
Arms & Interventions
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.
Intervention: Bronchoscopy (Procedure)
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.
Intervention: Yankauer Suction Device (Device)
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.
Intervention: Bronchoscopy (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Rayan Mohamad
Clinical Associate
American University of Beirut Medical Center