BronchoscopyNCT05912985
Three Different Oxygenation Strategies in Bronchoscopy Procedures Under Sedation
An observational study of Bronchoscopy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The purpose of study aims to determine which of the three different oxygenation strategies, including nasal cannula, modified nasopharyngeal cannula, and HFNO groups, is safer in patients undergoing bronchoscopy under sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchoscopy
- What is being tested?
- different oxygenation methods
- How many people
- 252 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Mar 2023to 1 Mar 2024
- Phase
- Observational
- 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
Study population: Patients admitted to the bronchoscopy unit for the procedure
Who may be able to join
- All patients undergoing bronchoscopy
Who cannot join
- Do not have the ability to read, understand and sign the consent form
- Pregnancy
- Contraindications to anesthetic drugs
- Hemodynamically unstable patients
- Having a peripheral vascular disease
- Intubated patients
- Patients with tracheostomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
Süleyman Taş, +9005067846913, tas_suleyman42@hotmail.com
About this study
Official title: Comparison of Three Different Oxygenation Strategies Consisting of Nasal Cannula, Modified Nasopharyngeal Cannula and HFNO (High Flow Nasal Oxygen) in Bronchoscopy Procedures Under Sedation
The purpose of study aims to determine which of the three different oxygenation strategies, including nasal cannula, modified nasopharyngeal cannula, and HFNO groups, is safer in patients undergoing bronchoscopy under sedation.
Read the detailed description
The patients will be evaluated in the anesthesia polyclinic before the procedure, routine preparation will be made, and written informed consent will be obtained. After being informed about the study and potential risks, all patients who gave written informed consent will be enrolled in the study by recording their demographic information after determining whether they are eligible to participate in the study. In addition, STOP-BANG and FRAIL fragility questionnaires will be administered to the patients. Which oxygenation method should be used which patient will be left to the decision of the Anesthesiologist; The oxygenation tools used in the bronchoscopy unit are nasal cannula, modified nasopharyngeal cannula, and HFNO. When the patients are taken to the procedure room, anesthesia management will be applied by the standard working order of the anesthesia clinic. In addition to non-invasive arterial blood pressure monitoring, 5-channel ECG and pulse oximetry, and standard hemodynamic monitoring, Bispectral Index (BIS) monitoring will be performed. During the process, oxygen saturation will be continuously monitored and the lowest value will be recorded. Interventions made in cases of low oxygen saturation will also be recorded. At the end of the procedure, the patient will be taken to the recovery unit after waking up.
- Conditions
- Bronchoscopy
- Being tested
- different oxygenation methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different oxygenation methodsOther
Different oxygenation methods are used in bronchoscopy procedures under sedation.
| Study group | Role | What they receive |
|---|---|---|
| nasal cannula group | Nasal cannula will be used in bronchoscopy procedures in which sedation is applied in this group. Receives: Other: different oxygenation methods | |
| modified nasopharyngeal cannula group | In this group, modified nasopharyngeal cannula will be used in bronchoscopy procedures with sedation. Receives: Other: different oxygenation methods | |
| HFNO group | HFNO will be used in bronchoscopy procedures in which sedation is applied in this group. Receives: Other: different oxygenation methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
desaturation rate during processing
desaturation: oxygen saturation falling below 90%. Oxygen saturation was monitored continuously with a pulse oximeter attached to one of the fingers. It was recorded when oxygen saturation dropped to < 90%.
Measured: during the procedure, an average of 1 hour
Secondary outcomes (2)
rate of use of the jaw thrust maneuver during the procedure
The chin thrust maneuver is one of the maneuvers used to provide airway patency. The jaw thrust maneuvers performed by the anesthesiologist were recorded in patients who were desaturated during the procedure.
Measured: during the procedure, an average of 1 hour
rate of airway usage during the process
The airway that was desaturated during the procedure and used by the anesthesiologist to ensure airway patency was recorded.
Measured: during the procedure, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start28 Mar 2023
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Süleyman Taş, Ankara City Hospital Bilkent
- Investigators
- süleyman taş, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912985
- Sponsor's protocol ID
- SuleymanTas1
- Status last verified
- Jun 2023
- First submitted
- 11 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Oxygenation Strategies Consisting of Nasal Cannula, Modified Nasopharyngeal Cannula and HFNO (High Flow Nasal Oxygen) in Bronchoscopy Procedures Under Sedation
- ClinicalTrials.gov ID
- NCT05912985
- Acronym / sponsor ID
- SuleymanTas1
- Conditions
- Bronchoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 22 Jun 2023 (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 study aims to determine which of the three different oxygenation strategies, including nasal cannula, modified nasopharyngeal cannula, and HFNO groups, is safer in patients undergoing bronchoscopy under sedation.
Detailed description
The patients will be evaluated in the anesthesia polyclinic before the procedure, routine preparation will be made, and written informed consent will be obtained. After being informed about the study and potential risks, all patients who gave written informed consent will be enrolled in the study by recording their demographic information after determining whether they are eligible to participate in the study. In addition, STOP-BANG and FRAIL fragility questionnaires will be administered to the patients. Which oxygenation method should be used which patient will be left to the decision of the Anesthesiologist; The oxygenation tools used in the bronchoscopy unit are nasal cannula, modified nasopharyngeal cannula, and HFNO. When the patients are taken to the procedure room, anesthesia management will be applied by the standard working order of the anesthesia clinic. In addition to non-invasive arterial blood pressure monitoring, 5-channel ECG and pulse oximetry, and standard hemodynamic monitoring, Bispectral Index (BIS) monitoring will be performed. During the process, oxygen saturation will be continuously monitored and the lowest value will be recorded. Interventions made in cases of low oxygen saturation will also be recorded. At the end of the procedure, the patient will be taken to the recovery unit after waking up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nasal cannula group | – | Other: different oxygenation methodsNasal cannula will be used in bronchoscopy procedures in which sedation is applied in this group. |
| modified nasopharyngeal cannula group | – | Other: different oxygenation methodsIn this group, modified nasopharyngeal cannula will be used in bronchoscopy procedures with sedation. |
| HFNO group | – | Other: different oxygenation methodsHFNO will be used in bronchoscopy procedures in which sedation is applied in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the bronchoscopy unit for the procedure
Key inclusion criteria (1 listed)
- All patients undergoing bronchoscopy
Key exclusion criteria (7 listed)
- Do not have the ability to read, understand and sign the consent form
- Pregnancy
- Contraindications to anesthetic drugs
- Hemodynamically unstable patients
- Having a peripheral vascular 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 |
|---|---|---|
| different oxygenation methodsDifferent oxygenation methods are used in bronchoscopy procedures under sedation. | Other | HFNO group, modified nasopharyngeal cannula group, nasal cannula group |
Primary outcome
desaturation rate during processing
Time frame: during the procedure, an average of 1 hour
desaturation: oxygen saturation falling below 90%. Oxygen saturation was monitored continuously with a pulse oximeter attached to one of the fingers. It was recorded when oxygen saturation dropped to < 90%.
2 secondary outcomes
rate of use of the jaw thrust maneuver during the procedure
Time frame: during the procedure, an average of 1 hour
rate of airway usage during the process
Time frame: during the procedure, an average of 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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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.
süleyman taş principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchoscopy, run by Ankara City Hospital Bilkent 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact süleyman taş (+9005067846913, tas_suleyman42@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
desaturation rate during processing (time frame: during the procedure, an average of 1 hour). 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 27 Jun 2023.