Lung DiseasesNCT04686656
Nasal Versus Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
A study testing nasal oxygen and buccal oxygen in people with Lung Diseases, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare to nasal and buccal oxygen administration in patients undergoing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration . Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- nasal oxygen and buccal oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2020to 6 Apr 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients ≥18 years of age
- body mass index (BMI) between 20 and 30
- American Society of Anesthesiologists physical status I-III
Who cannot join
- congestive heart failure
- ischemic heart disease
- increased intracranial pressure
- known allergy or contraindication to study drugs (propofol, fentanyl, or midazolam)
- an anatomical feature precluding adequate positioning of the buccal device.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Researching Hospital
Antalya
About this study
Official title: A Randomized Controlled Trial Comparing Nasal With Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
The purpose of this study is to compare to nasal and buccal oxygen administration in patients undergoing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration .
Read the detailed description
Anesthesia for Endobronchial Ultrasound (EBUS) may be range from routine bronchoscopy sedation to general anesthesia. During sedation to EBUS increased duration of anesthesia and sedative dosing put patients at increased risk for hypoxic events. To avoid this, oxygen supplementation is mandatory. There are different techniques for oxygen supplementation during the procedure. At this study we will compare to nasal and buccal oxygen supplementations during EBUS.
- Conditions
- Lung Diseases
- Being tested
- nasal oxygen, buccal oxygen
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal oxygenOther
Nasal cannula will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with nasal cannula.
buccal oxygenOther
Ring-adair-elwyn (RAE) tube will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with RAE tube.
| Study group | Role | What they receive |
|---|---|---|
| nasal oxygen supplementation group | Active comparator | supplemental oxygen will be administered with nasal cannula Receives: Other: nasal oxygen |
| buccal oxygen supplementation group | Active comparator | supplemental oxygen will be administered with Ring-Adair-Elwyn (RAE) tube Receives: Other: buccal oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoxia-related interruptions
the number of hypoxia-related interruptions
Measured: 30 minutes
Secondary outcomes (4)
duration of procedure
Duration of procedure will be defined in minute as the time from starting to insert EBUS device until the time to remove the device
Measured: 30 minutes
use of propofol
The use of amount of propofol will be noted during the procedure.
Measured: 30 minutes
use of fentanyl
The use of amount of fentanyl will be noted during the procedure.
Measured: 30 minutes
satisfaction of pulmonary specialist
satisfaction of pulmonary specialist will be evaluated by 4-points Likert Scale
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start24 Dec 2020
- Primary completion24 Feb 2021
- Study completion6 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- tayfun sugur, MD, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686656
- Sponsor's protocol ID
- tayfun1
- Status last verified
- Dec 2020
- First submitted
- 23 Dec 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Nasal With Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
- ClinicalTrials.gov ID
- NCT04686656
- Acronym / sponsor ID
- tayfun1
- Conditions
- Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 29 Dec 2020 (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 purpose of this study is to compare to nasal and buccal oxygen administration in patients undergoing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration .
Detailed description
Anesthesia for Endobronchial Ultrasound (EBUS) may be range from routine bronchoscopy sedation to general anesthesia. During sedation to EBUS increased duration of anesthesia and sedative dosing put patients at increased risk for hypoxic events. To avoid this, oxygen supplementation is mandatory. There are different techniques for oxygen supplementation during the procedure. At this study we will compare to nasal and buccal oxygen supplementations during EBUS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal oxygen supplementation group | Active comparator | Other: nasal oxygensupplemental oxygen will be administered with nasal cannula |
| buccal oxygen supplementation group | Active comparator | Other: buccal oxygensupplemental oxygen will be administered with Ring-Adair-Elwyn (RAE) tube |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients ≥18 years of age
- body mass index (BMI) between 20 and 30
- American Society of Anesthesiologists physical status I-III
Key exclusion criteria (5 listed)
- congestive heart failure
- ischemic heart disease
- increased intracranial pressure
- known allergy or contraindication to study drugs (propofol, fentanyl, or midazolam)
- an anatomical feature precluding adequate positioning of the buccal device.
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 |
|---|---|---|
| nasal oxygenNasal cannula will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with nasal cannula. | Other | nasal oxygen supplementation group |
| buccal oxygenRing-adair-elwyn (RAE) tube will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with RAE tube. | Other | buccal oxygen supplementation group |
Primary outcome
hypoxia-related interruptions
Time frame: 30 minutes
the number of hypoxia-related interruptions
4 secondary outcomes
duration of procedure
Time frame: 30 minutes
use of propofol
Time frame: 30 minutes
use of fentanyl
Time frame: 30 minutes
satisfaction of pulmonary specialist
Time frame: 30 minutes
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 8 Apr 2021.
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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.
tayfun sugur, MD principal investigator
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal oxygen and buccal oxygen in people with Lung Diseases, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
hypoxia-related interruptions (time frame: 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 8 Apr 2021.