An interventional study of HİGH FLOW NASAL CANNULA OXYGEN and NASAL CANNULA OXYGEN in Hypoxemia, Eldery People and Endoscopy, sponsored by Turkish Society of Anesthesiology and Reanimation. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Turkish Society of Anesthesiology and Reanimation · Not applicable, Interventional, and Prevention
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.
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.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's planned enrollment of 154 is above the median of 45 across 769 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Turkish Society of Anesthesiology and Reanimation is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HİGH FLOW NASAL CANNULA OXYGEN
Procedure: HİGH FLOW NASAL CANNULA OXYGEN
NASAL CANNULA OXYGEN
Procedure: NASAL CANNULA OXYGEN
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.
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.
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.
Time frame: persists for at least 10 seconds during sedation and endoscopy.
Minimum SpO₂ During the Procedure:
The lowest peripheral oxygen saturation (SpO₂) value (%) recorded by pulse oximetry during sedation and endoscopy will be assessed.
Time frame: 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.
Time frame: 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.
Time frame: end of the procedure
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Sep 2027, 7 months later.
Of 321 non-industry interventional studies with no phase under Hypoxia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 7 months is below that.
Counting every sponsor, half of 351 studies reached it within 12 months; a quarter within 3 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Turkish Society of Anesthesiology and Reanimation