HypoxemiaNCT07916298
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
A study testing HİGH FLOW NASAL CANNULA OXYGEN and NASAL CANNULA OXYGEN in people with Hypoxemia and Eldery People, run by Turkish Society of Anesthesiology and Reanimation at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare high-flow nasal oxygen (HFNO) with conventional nasal cannula oxygen during sedation for combined upper and lower gastrointestinal endoscopy (gastroscopy and colonoscopy) in patients aged 75 years and older. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxemia, Eldery People, Endoscopy
- What is being tested?
- HİGH FLOW NASAL CANNULA OXYGEN and NASAL CANNULA OXYGEN
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2027to 1 Oct 2027
- Phase
- Interventional
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 75 years or older.
- American Society of Anesthesiologists (ASA) physical status classification of I-III.
- Scheduled to undergo elective gastroscopy and colonoscopy during the same session.
- Provision of written informed consent.
Who cannot join
- Patients undergoing emergency procedures.
- Patients who do not provide written informed consent.
- History of allergy to propofol, egg, or soy.
- Opioid tolerance.
- Moderate to severe morbid obesity, defined as a body mass index (BMI) ≥ 35 kg/m².
- History of severe obstructive sleep apnea syndrome (OSAS), defined as a known apnea-hypopnea index (AHI) > 40 events/hour or a documented diagnosis of severe OSAS.
- Use of long-term home oxygen therapy.
- Infection or tumor involving the oral cavity, nose, or pharynx.
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
T.C Sağlık Bakanlığı Bursa Şehir Hastanesi
Bursa, nilüfer, 16130
Tutku Karaman Sağlam, specialist, +905373445246, tutkuukrmnn@gmail.com
About this study
Official title: Comparison of High-Flow Nasal Oxygen and Conventional Nasal Oxygen During Combined Upper and Lower Gastrointestinal Endoscopy Sedation in Elderly Patients
This study aims to compare high-flow nasal oxygen (HFNO) with conventional nasal cannula oxygen during sedation for combined upper and lower gastrointestinal endoscopy (gastroscopy and colonoscopy) in patients aged 75 years and older.
Sedation is commonly used during gastrointestinal endoscopic procedures to improve patient comfort. However, sedative medications may cause respiratory depression and hypoxemia. Conventional nasal cannula oxygen is routinely used to provide supplemental oxygen, whereas high-flow nasal oxygen delivers heated and humidified oxygen at higher flow rates and may help maintain oxygenation during sedation. The effectiveness of high-flow nasal oxygen in older patients undergoing gastroscopy and colonoscopy during the same session requires further evaluation.
Read more
In this randomized controlled study, eligible patients will be assigned to one of two groups. In the high-flow nasal oxygen group, preoxygenation will be administered for 3 minutes at a flow rate of 40 L/min with an inspired oxygen fraction (FiO₂) of 50%. Once the target sedation level is achieved, the flow rate will be increased to 60 L/min, with FiO₂ maintained at 50%, and oxygen support will continue until the end of the procedure. In the conventional nasal cannula group, oxygen will be administered at a flow rate of 6 L/min for 3 minutes before sedation and continued throughout the procedure. Patients in both groups will maintain spontaneous breathing.
The primary outcome is the occurrence of hypoxemia, defined as peripheral oxygen saturation (SpO₂) below 90% for at least 10 seconds during sedation and endoscopy. SpO₂ will be continuously monitored throughout the procedure. Secondary outcomes include the minimum SpO₂, total duration of hypoxemia, apnea episodes, the need for airway or ventilation interventions, changes in hemodynamic parameters, sedative and analgesic medication requirements, procedure duration, and adverse events. Any rescue interventions performed in response to hypoxemia or respiratory compromise will be recorded.
The study will evaluate whether high-flow nasal oxygen reduces the incidence of hypoxemia compared with conventional nasal cannula oxygen in patients aged 75 years and older undergoing combined upper and lower gastrointestinal endoscopy under sedation. The findings may help inform oxygen supplementation strategies for this older patient population.
Read the detailed description
Older adults may be particularly vulnerable to respiratory complications during sedation for gastrointestinal endoscopic procedures because of age-related physiological changes and increased sensitivity to sedative medications. Hypoxemia may occur during sedation and can require airway maneuvers or additional respiratory support. Maintaining adequate oxygenation is therefore an important aspect of procedural sedation in this population.
High-flow nasal oxygen (HFNO) provides heated and humidified gas at high flow rates and may support oxygenation during sedation. Compared with conventional nasal cannula oxygen, this approach may offer advantages in maintaining oxygen delivery and reducing the occurrence of oxygen desaturation. However, evidence regarding its effectiveness in patients aged 75 years and older undergoing combined upper and lower gastrointestinal endoscopy during the same session remains limited.
This prospective, randomized, controlled study will compare high-flow nasal oxygen with conventional nasal cannula oxygen in older patients undergoing sedated combined gastroscopy and colonoscopy. Participants will be allocated to one of the two oxygen-delivery groups according to a computer-generated randomization sequence. Oxygen supplementation will be initiated before sedation and maintained throughout the procedure according to the assigned group protocol.
Respiratory and cardiovascular parameters will be monitored during the procedure. The study will assess the occurrence of hypoxemia and other respiratory events, the need for airway or ventilation interventions, changes in hemodynamic parameters, sedative medication requirements, procedure-related durations, and adverse events.
The study is intended to provide evidence on whether high-flow nasal oxygen offers a clinical advantage over conventional nasal cannula oxygen for maintaining oxygenation during combined gastrointestinal endoscopy under sedation in patients aged 75 years and older. The findings may help inform oxygen-delivery strategies for this older patient population.
- Being tested
- HİGH FLOW NASAL CANNULA OXYGEN, NASAL CANNULA OXYGEN
- Keywords
- HFNC, HFNO, HYPOXEMİA, APNEA
- Medical subject headings
- Hypoxia, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HİGH FLOW NASAL CANNULA OXYGENProcedure or surgery
High-flow nasal oxygen will be administered using a high-flow nasal cannula system at a flow rate of 60 L/min, a gas temperature of 35°C, and an inspired oxygen fraction (FiO₂) of 50%. Oxygen administration will begin 3 minutes before sedation and continue throughout the combined upper and lower gastrointestinal endoscopy procedure.
NASAL CANNULA OXYGENProcedure or surgery
Conventional oxygen will be administered through a standard nasal cannula at a flow rate of 6 L/min. Oxygen administration will begin 3 minutes before sedation and continue throughout the combined upper and lower gastrointestinal endoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| HFNC | Active comparator | HİGH FLOW NASAL CANNULA OXYGEN Receives: Procedure: HİGH FLOW NASAL CANNULA OXYGEN |
| NC | Active comparator | NASAL CANNULA OXYGEN Receives: Procedure: NASAL CANNULA OXYGEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
The primary outcome of the study is the occurrence of hypoxemia, defined as a peripheral oxygen saturation (SpO₂) below 90% that persists for at least 10 seconds during sedation and endoscopy.
Measured: persists for at least 10 seconds during sedation and endoscopy.
Secondary outcomes (3)
Minimum SpO₂ During the Procedure:
The lowest peripheral oxygen saturation (SpO₂) value (%) recorded by pulse oximetry during sedation and endoscopy will be assessed.
Measured: end of the procedure
Total Duration of Hypoxemia
The total duration (in seconds) during which SpO₂ remains below 90% during sedation and endoscopy will be recorded and compared between the two groups.
Measured: end of the procedure
Requirement for Airway Interventions
Airway and respiratory support interventions performed due to hypoxemia or respiratory depression during sedation and endoscopy will be evaluated. These interventions will include the jaw-thrust maneuver, tactile or painful stimulation, repositioning of the head and neck, use of airway adjuncts, and bag-mask ventilation when necessary. The proportion of patients requiring at least one airway intervention will be compared between the two groups.
Measured: end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish Society of Anesthesiology and Reanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, UTKU SAĞLAM, Turkish Society of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916298
- Sponsor's protocol ID
- HFNC-NC-75-001
- Status last verified
- Nov 2026
- First submitted
- 26 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High-Flow Nasal Oxygen and Conventional Nasal Oxygen During Combined Upper and Lower Gastrointestinal Endoscopy Sedation in Elderly Patients
- ClinicalTrials.gov ID
- NCT07916298
- Acronym / sponsor ID
- HFNC-NC-75-001
- Keywords
- HFNC, HFNO, HYPOXEMİA, APNEA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Turkish Society of Anesthesiology and ReanimationUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 4 Nov 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 compare high-flow nasal oxygen (HFNO) with conventional nasal cannula oxygen during sedation for combined upper and lower gastrointestinal endoscopy (gastroscopy and colonoscopy) in patients aged 75 years and older.
Sedation is commonly used during gastrointestinal endoscopic procedures to improve patient comfort. However, sedative medications may cause respiratory depression and hypoxemia. Conventional nasal cannula oxygen is routinely used to provide supplemental oxygen, whereas high-flow nasal oxygen delivers heated and humidified oxygen at higher flow rates and may help maintain oxygenation during sedation. The effectiveness of high-flow nasal oxygen in older patients undergoing gastroscopy and colonoscopy during the same session requires further evaluation.
In this randomized controlled study, eligible patients will be assigned to one of two groups. In the high-flow nasal oxygen group, preoxygenation will be administered for 3 minutes at a flow rate of 40 L/min with an inspired oxygen fraction (FiO₂) of 50%. Once the target sedation level is achieved, the flow rate will be increased to 60 L/min, with FiO₂ maintained at 50%, and oxygen support will continue until the end of the procedure. In the conventional nasal cannula group, oxygen will be administered at a flow rate of 6 L/min for 3 minutes before sedation and continued throughout the procedure. Patients in both groups will maintain spontaneous breathing.
The primary outcome is the occurrence of hypoxemia, defined as peripheral oxygen saturation (SpO₂) below 90% for at least 10 seconds during sedation and endoscopy. SpO₂ will be continuously monitored throughout the procedure. Secondary outcomes include the minimum SpO₂, total duration of hypoxemia, apnea episodes, the need for airway or ventilation interventions, changes in hemodynamic parameters, sedative and analgesic medication requirements, procedure duration, and adverse events. Any rescue interventions performed in response to hypoxemia or respiratory compromise will be recorded.
The study will evaluate whether high-flow nasal oxygen reduces the incidence of hypoxemia compared with conventional nasal cannula oxygen in patients aged 75 years and older undergoing combined upper and lower gastrointestinal endoscopy under sedation. The findings may help inform oxygen supplementation strategies for this older patient population.
Detailed description
Older adults may be particularly vulnerable to respiratory complications during sedation for gastrointestinal endoscopic procedures because of age-related physiological changes and increased sensitivity to sedative medications. Hypoxemia may occur during sedation and can require airway maneuvers or additional respiratory support. Maintaining adequate oxygenation is therefore an important aspect of procedural sedation in this population.
High-flow nasal oxygen (HFNO) provides heated and humidified gas at high flow rates and may support oxygenation during sedation. Compared with conventional nasal cannula oxygen, this approach may offer advantages in maintaining oxygen delivery and reducing the occurrence of oxygen desaturation. However, evidence regarding its effectiveness in patients aged 75 years and older undergoing combined upper and lower gastrointestinal endoscopy during the same session remains limited.
This prospective, randomized, controlled study will compare high-flow nasal oxygen with conventional nasal cannula oxygen in older patients undergoing sedated combined gastroscopy and colonoscopy. Participants will be allocated to one of the two oxygen-delivery groups according to a computer-generated randomization sequence. Oxygen supplementation will be initiated before sedation and maintained throughout the procedure according to the assigned group protocol.
Respiratory and cardiovascular parameters will be monitored during the procedure. The study will assess the occurrence of hypoxemia and other respiratory events, the need for airway or ventilation interventions, changes in hemodynamic parameters, sedative medication requirements, procedure-related durations, and adverse events.
The study is intended to provide evidence on whether high-flow nasal oxygen offers a clinical advantage over conventional nasal cannula oxygen for maintaining oxygenation during combined gastrointestinal endoscopy under sedation in patients aged 75 years and older. The findings may help inform oxygen-delivery strategies for this older patient population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC | Active comparator | Procedure: HİGH FLOW NASAL CANNULA OXYGENHİGH FLOW NASAL CANNULA OXYGEN |
| NC | Active comparator | Procedure: NASAL CANNULA OXYGENNASAL CANNULA OXYGEN |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 75 years or older.
- American Society of Anesthesiologists (ASA) physical status classification of I-III.
- Scheduled to undergo elective gastroscopy and colonoscopy during the same session.
- Provision of written informed consent.
Key exclusion criteria (8 listed)
- Patients undergoing emergency procedures.
- Patients who do not provide written informed consent.
- History of allergy to propofol, egg, or soy.
- Opioid tolerance.
- Moderate to severe morbid obesity, defined as a body mass index (BMI) ≥ 35 kg/m².
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 |
|---|---|---|
| HİGH FLOW NASAL CANNULA OXYGENHigh-flow nasal oxygen will be administered using a high-flow nasal cannula system at a flow rate of 60 L/min, a gas temperature of 35°C, and an inspired oxygen fraction (FiO₂) of 50%. Oxygen administration will begin 3 minutes before sedation and continue throughout the combined upper and lower gastrointestinal endoscopy procedure. | Procedure or surgery | HFNC |
| NASAL CANNULA OXYGENConventional oxygen will be administered through a standard nasal cannula at a flow rate of 6 L/min. Oxygen administration will begin 3 minutes before sedation and continue throughout the combined upper and lower gastrointestinal endoscopy procedure. | Procedure or surgery | NC |
Primary outcome
Hypoxemia
Time frame: persists for at least 10 seconds during sedation and endoscopy.
The primary outcome of the study is the occurrence of hypoxemia, defined as a peripheral oxygen saturation (SpO₂) below 90% that persists for at least 10 seconds during sedation and endoscopy.
3 secondary outcomes
Minimum SpO₂ During the Procedure:
Time frame: end of the procedure
Total Duration of Hypoxemia
Time frame: end of the procedure
Requirement for Airway Interventions
Time frame: end of the 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 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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?
A study testing HİGH FLOW NASAL CANNULA OXYGEN and NASAL CANNULA OXYGEN in people with Hypoxemia and Eldery People, run by Turkish Society of Anesthesiology and Reanimation 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 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: opening soon, as of the sponsor's last update on 4 Nov 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 utku sağlam, specialist (+905079701310, utkusaglam23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia (time frame: persists for at least 10 seconds during sedation and endoscopy.). 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 Nov 2026.