BronchoscopyNCT06908109
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
A study testing Yankauer Suction Device and Bronchoscopy in people with Bronchoscopy, run by American University of Beirut Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchoscopy
- What is being tested?
- Yankauer Suction Device and Bronchoscopy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2016to 14 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Bronchoscopy
- Being tested
- Yankauer Suction Device, Bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yankauer Suction DeviceDevice
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.
BronchoscopyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Yankauer Suction Device; Procedure: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean doses of Midazolam and Fentanyl
From the time of enrollment (pre-bronchoscopy) to the end of the bronchoscopic procedure
Measured: From enrollment (pre-bronchoscopy) to the end of the bronchoscopic procedure (up to 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start4 Mar 2016
- Primary completion14 Oct 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rayan Mohamad, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908109
- Sponsor's protocol ID
- IM.IBA.03
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Oral Suctioning During Flexible Bronchoscopy: Effect on Sedative Medication Needs and Both Endoscopist's and Patient's Satisfaction
- ClinicalTrials.gov ID
- NCT06908109
- Acronym / sponsor ID
- IM.IBA.03
- Conditions
- Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Group | Sham comparator | Procedure: BronchoscopyThe 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. |
| Yankauer group | Active comparator | Device: Yankauer Suction Device, Procedure: BronchoscopyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yankauer Suction DeviceThe 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. | Device | Yankauer group |
| BronchoscopyFlexible 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 | Procedure or surgery | Sham Group, Yankauer group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Bronchoscopy
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
Postoperative Sore Throat, Bronchoscopy
RecruitingObservational study
Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
Operator Radiation Exposure
Not yet recruitingPhase 2
Study of Robotic Assisted/Image Guided Electromagnetic Navigation Bronchoscopic Therapies and Surgery in Stage IA NSCLC
Stage IA NSCLC
Active, not recruitingObservational study
Analysis of Specimens From Individuals With Pulmonary Fibrosis
Pulmonary Fibrosis, Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Yankauer Suction Device and Bronchoscopy in people with Bronchoscopy, run by American University of Beirut Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean doses of Midazolam and Fentanyl (time frame: From enrollment (pre-bronchoscopy) to the end of the bronchoscopic procedure (up to 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.