High Flow Oxygen TherapyNCT07760727
High-Flow Nasal Oxygyen Therapy During Sedated Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration(EBUS-TBNA)
An observational study of High Flow Oxygen Therapy and ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of high-flow nasal oxygen therapy on respiratory complications, blood gas parameters, and post-procedural recovery in patients undergoing sedated endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Flow Oxygen Therapy, ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Sedation
- What is being tested?
- High-Flow Nasal Oxygen Therapy and Conventional Oxygen Therapy
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2026to 20 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients (≥18 years) scheduled to undergo sedated endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) at Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital. Participants will be allocated to receive either high-flow nasal oxygen therapy or conventional oxygen therapy during the procedure
Who may be able to join
- Age ≥18 years. Scheduled to undergo sedated EBUS-TBNA. Ability to provide written informed consent. ASA physical status I-III.
Who cannot join
- Age <18 years.
- Pregnancy.
- Requirement for endotracheal intubation or general anesthesia.
- Severe hemodynamic instability.
- Refusal to participate in the study.
- Contraindication to high-flow nasal oxygen therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Dr. Abdurrahman Yurtaslan Oncolgy Training and Research Hospital
Ankara, Central, 0620
ÖZLEM KAPUSUZ KÖRDUMAN, MD, 05058002027, zlmkpsz@hotmail.com
Guldeniz Argun, +9005336230405, guldargun@yahoo.com
About this study
Official title: The Effects of High-Flow Nasal Oxygen Therapy on Respiratory Complications and Post-Procedural Recovery Time in Patients Undergoing Sedated EBUS-TBNA
This study aims to evaluate the effects of high-flow nasal oxygen therapy on respiratory complications, blood gas parameters, and post-procedural recovery in patients undergoing sedated endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Participants will be assigned to receive either high-flow nasal oxygen therapy or conventional oxygen therapy during the procedure. The incidence of respiratory complications, blood gas changes, and recovery outcomes will be compared between the two groups.
- Conditions
- High Flow Oxygen Therapy, ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Sedation, Sedation Complication, Blood Gas Analysis
- Being tested
- High-Flow Nasal Oxygen Therapy, Conventional Oxygen Therapy
- Keywords
- High flow oxygen therapy,, Endobronchial Ultrasound-Transbronchial Needle Aspiration(EBUS-TBNA), Sedation, Sedation Complications, Blood Gas Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Nasal Oxygen TherapyDevice
High-flow nasal oxygen therapy administered during sedated EBUS-TBNA procedures to provide enhanced oxygenation and respiratory support.
Conventional Oxygen TherapyDevice
Conventional oxygen therapy administered during sedated EBUS-TBNA procedures using standard oxygen delivery methods
| Study group | Role | What they receive |
|---|---|---|
| Group H (High-Flow Nasal Oxygen Group) | Patients undergoing sedated EBUS-TBNA who receive high-flow nasal oxygen therapy during the procedure. Respiratory complications, oxygenation parameters, blood gas values, and post-procedural recovery outcomes are evaluated. Receives: Device: High-Flow Nasal Oxygen Therapy | |
| Group C (Conventional Oxygen Group) | Patients undergoing sedated EBUS-TBNA who receive conventional oxygen therapy during the procedure. Respiratory complications, oxygenation parameters, blood gas values, and post-procedural recovery outcomes are evaluated. Receives: Device: Conventional Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Complications
Incidence of respiratory complications during sedated EBUS-TBNA, including hypoxemia, oxygen desaturation, apnea, airway obstruction, and the need for airway interventions.
Measured: During the procedure
Secondary outcomes (5)
Oxygen partial pressure (PaO2)
Changes in venous oxygen partial pressure(PaO2) measured at baseline and after sedated EBUS-TBNA
Measured: Baseline and within 15 minutes after completion of the endobronchial Ultrasound-Transbronchial Needle Aspiration (EBUS-TBNA) procedure
Carbon dioxide partial pressure (PvCO2)
Changes in venous carbon dioxide partial pressure (PvCO2) measured at baseline and within 15 minutes after completion of sedated EBUS-TBNA.
Measured: Baseline and within 15 minutes after completion of the EBUS-TBNA
Venous pH
Changes in venous pH measured at baseline and within 15 minutes after completion of sedated EBUS-TBNA
Measured: Baseline and within 15 minutes after completion of the EBUS-TBNA procedure.
Venous Oxygen Saturation (SvO2)
Changes in venous oxygen saturation (SvO2) measured at baseline and within 15 minutes after completion of sedated EBUS-TBNA.
Measured: Baseline and within 15 minutes after completion of the EBUS-TBNA procedure.
Recovry Time
Time from completion of sedated EBUS-TBNA until achievement of a Modified ALdrete Recovery Score ≥9.
Measured: Up to 2 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Flow Oxygen TherapyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Kapusuz, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760727
- Sponsor's protocol ID
- SBU2026-02/37
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sampsonas F, Karamouzos V, Karampitsakos T, Papaioannou O, Katsaras M, Lagadinou M, Zarkadi E, Malakounidou E, Velissaris D, Stratakos G, Tzouvelekis A. High-Flow vs. Low-Flow Nasal Cannula in Reducing Hypoxemic Events During Bronchoscopic Procedures: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2022 Feb 24;9:815799. doi: 10.3389/fmed.2022.815799. eCollection 2022.
PubMed 35280891
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-Flow Nasal Oxygen Therapy on Respiratory Complications and Post-Procedural Recovery Time in Patients Undergoing Sedated EBUS-TBNA
- ClinicalTrials.gov ID
- NCT07760727
- Acronym / sponsor ID
- SBU2026-02/37
- Conditions
- High Flow Oxygen Therapy, ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Sedation, Sedation Complication, Blood Gas Analysis
- Keywords
- High flow oxygen therapy,, Endobronchial Ultrasound-Transbronchial Needle Aspiration(EBUS-TBNA), Sedation, Sedation Complications, Blood Gas Analysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 12 Aug 2026 (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.
This study aims to evaluate the effects of high-flow nasal oxygen therapy on respiratory complications, blood gas parameters, and post-procedural recovery in patients undergoing sedated endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Participants will be assigned to receive either high-flow nasal oxygen therapy or conventional oxygen therapy during the procedure. The incidence of respiratory complications, blood gas changes, and recovery outcomes will be compared between the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group H (High-Flow Nasal Oxygen Group) | – | Device: High-Flow Nasal Oxygen TherapyPatients undergoing sedated EBUS-TBNA who receive high-flow nasal oxygen therapy during the procedure. Respiratory complications, oxygenation parameters, blood gas values, and post-procedural recovery outcomes are evaluated. |
| Group C (Conventional Oxygen Group) | – | Device: Conventional Oxygen TherapyPatients undergoing sedated EBUS-TBNA who receive conventional oxygen therapy during the procedure. Respiratory complications, oxygenation parameters, blood gas values, and post-procedural recovery outcomes are evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) scheduled to undergo sedated endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) at Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital. Participants will be allocated to receive either high-flow nasal oxygen therapy or conventional oxygen therapy during the procedure
Key inclusion criteria (1 listed)
- Age ≥18 years. Scheduled to undergo sedated EBUS-TBNA. Ability to provide written informed consent. ASA physical status I-III.
Key exclusion criteria (6 listed)
- Age <18 years.
- Pregnancy.
- Requirement for endotracheal intubation or general anesthesia.
- Severe hemodynamic instability.
- Refusal to participate in the study.
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 |
|---|---|---|
| High-Flow Nasal Oxygen TherapyHigh-flow nasal oxygen therapy administered during sedated EBUS-TBNA procedures to provide enhanced oxygenation and respiratory support. | Device | Group H (High-Flow Nasal Oxygen Group) |
| Conventional Oxygen TherapyConventional oxygen therapy administered during sedated EBUS-TBNA procedures using standard oxygen delivery methods | Device | Group C (Conventional Oxygen Group) |
Primary outcome
Respiratory Complications
Time frame: During the procedure
Incidence of respiratory complications during sedated EBUS-TBNA, including hypoxemia, oxygen desaturation, apnea, airway obstruction, and the need for airway interventions.
5 secondary outcomes
Oxygen partial pressure (PaO2)
Time frame: Baseline and within 15 minutes after completion of the endobronchial Ultrasound-Transbronchial Needle Aspiration (EBUS-TBNA) procedure
Carbon dioxide partial pressure (PvCO2)
Time frame: Baseline and within 15 minutes after completion of the EBUS-TBNA
Venous pH
Time frame: Baseline and within 15 minutes after completion of the EBUS-TBNA procedure.
Venous Oxygen Saturation (SvO2)
Time frame: Baseline and within 15 minutes after completion of the EBUS-TBNA procedure.
Recovry Time
Time frame: Up to 2 hours post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 35280891Sampsonas F, Karamouzos V, Karampitsakos T, Papaioannou O, Katsaras M, Lagadinou M, Zarkadi E, Malakounidou E, Velissaris D, Stratakos G, Tzouvelekis A. High-Flow vs. Low-Flow Nasal Cannula in Reducing Hypoxemic Events During Bronchoscopic Procedures: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2022 Feb 24;9:815799. doi: 10.3389/fmed.2022.815799. eCollection 2022.
- 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.
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 High Flow Oxygen Therapy and ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, run by Dr Abdurrahman Yurtaslan Ankara Oncology 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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 12 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ÖZLEM KAPUSUZ KÖRDUMAN, MD (+905058002027, zlmkpsz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Complications (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07760727, which also lists 1 linked publication.
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 12 Aug 2026.