HypoxemiaNAMSHICNCT07500779
Impact of Nasal Mask Versus Nasal Cannula Oxygenation on Hypoxemia in Gastrointestinal Endoscopy: A Brain Function Monitoring (SedLine)-Guided Randomized Controlled Trial (NAMSHIC)
A study testing Nasal Mask Oxygenation and Nasal Cannula Oxygenation in people with Hypoxemia and Conscious Sedation, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial compared the efficacy of a nasal mask versus a standard nasal cannula for oxygen delivery during gastrointestinal endoscopic procedures performed under target controlled propofol infusion anesthesia with SedLine brain function monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Conscious Sedation
- What is being tested?
- Nasal Mask Oxygenation and Nasal Cannula Oxygenation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2025to 15 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Scheduled for gastrointestinal endoscopic procedures (upper endoscopy and or colonoscopy) under propofol sedation using target controlled infusion with SedLine monitoring.
- American Society of Anesthesiologists (ASA) physical status I to III.
- Provided written informed consent.
Who cannot join
- Refusal or inability to provide informed consent.
- Known allergy or contraindication to propofol or study related materials.
- Severe cardiorespiratory instability or conditions judged by the investigator to increase procedural risk.
- Pregnancy.
- Requirement for tracheal intubation or general anesthesia at the outset of the procedure.
- Significant anatomic or clinical factors precluding use of the assigned oxygen delivery device.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital
Istanbul
About this study
Official title: Comparison of the Efficacy of Nasal Mask and Nasal Cannula Oxygenation During Gastrointestinal Endoscopic Procedures Performed Under Target-Controlled Propofol Infusion Anesthesia With Brain Function Monitoring (SedLine): A Randomized Controlled Trial
This randomized controlled trial compared the efficacy of a nasal mask versus a standard nasal cannula for oxygen delivery during gastrointestinal endoscopic procedures performed under target controlled propofol infusion anesthesia with SedLine brain function monitoring. Hypoxemia during procedural sedation is a common and clinically relevant event, especially during upper endoscopy and combined procedures. The study aimed to determine whether nasal mask oxygenation reduces hypoxemia compared with nasal cannula oxygenation when sedation depth is guided with electroencephalography based monitoring.
Eligible adult patients undergoing gastrointestinal endoscopic procedures were randomly assigned to receive oxygen either via a nasal mask or via a nasal cannula. Oxygen was administered at a fixed flow rate according to the study protocol. Sedation was provided with target controlled propofol infusion, and SedLine monitoring was used to guide sedation depth throughout the procedure.
The primary outcome was the occurrence of hypoxemia, defined as peripheral oxygen saturation at or below 90 percent. Secondary outcomes included severe hypoxemia, duration of hypoxemia, lowest peripheral oxygen saturation value, need for airway interventions, other adverse events during the procedure, procedure time, recovery time, and operator satisfaction ratings. The study has been completed.
Read the detailed description
This study was a prospective randomized controlled trial designed to compare two oxygen delivery approaches during gastrointestinal endoscopic procedures performed under target controlled propofol infusion anesthesia with SedLine brain function monitoring. The main objective was to evaluate whether nasal mask oxygenation provides better protection against hypoxemia than standard nasal cannula oxygenation when sedation depth is actively guided with electroencephalography based monitoring.
Adult patients scheduled for gastrointestinal endoscopic procedures were assessed for eligibility and enrolled after appropriate ethical approval and informed consent procedures in accordance with local regulations. Participants were randomly assigned to one of two groups. In the nasal mask group, oxygen was delivered using a nasal mask device. In the nasal cannula group, oxygen was delivered using a standard nasal cannula. Oxygen flow was administered as specified in the protocol. Sedation for all patients was provided with target controlled propofol infusion. SedLine brain function monitoring was used to guide and standardize sedation depth during the procedure to reduce variability related to over sedation or under sedation.
The primary outcome was hypoxemia, defined as peripheral oxygen saturation at or below 90 percent. Secondary outcomes included severe hypoxemia, duration of hypoxemia, the minimum peripheral oxygen saturation recorded, need for airway support or rescue interventions, procedure related adverse events such as cough, hiccup, nausea, vomiting, reflux, aspiration, and laryngospasm, total procedure time, recovery time, and satisfaction ratings by the anesthesiologist and the endoscopist. All outcomes were assessed during the procedure and the immediate recovery period based on standardized definitions in the study protocol. The study has been completed, and the collected data are intended to support evaluation of the comparative effectiveness and safety of nasal mask versus nasal cannula oxygenation in this clinical setting.
- Conditions
- Hypoxemia, Conscious Sedation
- Being tested
- Nasal Mask Oxygenation, Nasal Cannula Oxygenation
- Keywords
- Gastrointestinal Endoscopy, Propofol, Target-Controlled Infusion, SedLine, Nasal Mask, Nasal Cannula, Oxygenation, Pulse Oximetry
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Mask OxygenationDevice
Oxygen supplementation delivered via a nasal mask at the protocol specified flow rate during the procedure.
Nasal Cannula OxygenationDevice
Oxygen supplementation delivered via a standard nasal cannula at the protocol specified flow rate during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Nasal Mask Oxygenation | Experimental | Oxygen was delivered via a nasal mask during gastrointestinal endoscopic procedures performed under target controlled propofol infusion with SedLine brain function monitoring. Receives: Device: Nasal Mask Oxygenation |
| Nasal Cannula Oxygenation | Active comparator | Oxygen was delivered via a standard nasal cannula during gastrointestinal endoscopic procedures performed under target controlled propofol infusion with SedLine brain function monitoring. Receives: Device: Nasal Cannula Oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
Occurrence of hypoxemia defined as peripheral oxygen saturation (SpO2) ≤ 90% during the procedure
Measured: During the endoscopic procedure and immediate recovery period (from start of sedation to discharge from the recovery area).
Secondary outcomes (8)
Severe hypoxemia
SpO2 ≤ 75% at any time, or SpO2 ≤ 90% lasting ≥ 60 seconds.
Measured: During the endoscopic procedure and immediate recovery period
Duration of hypoxemia
Total duration (seconds) with SpO2 ≤ 90%.
Measured: During the endoscopic procedure and immediate recovery period.
Minimum SpO2
Lowest SpO2 recorded during the procedure.
Measured: During the endoscopic procedure
Need for airway interventions
Any airway rescue or supportive intervention required (e.g., airway repositioning, jaw thrust, increased oxygen, mask ventilation, or other emergency airway management).
Measured: During the endoscopic procedure and immediate recovery period
Procedure-related adverse events
Cough, hiccup, nausea, vomiting, reflux, aspiration, laryngospasm, and other adverse events.
Measured: During the endoscopic procedure and immediate recovery period.
Procedure time
Total procedure duration (minutes).
Measured: During the procedure.
Recovery time
Time from end of procedure to readiness for discharge from recovery (minutes).
Measured: Immediately after the procedure
Satisfaction ratings
Anesthesiologist and endoscopist satisfaction assessed using a 0-100 Numeric Rating Scale, where 0 = least satisfied and 100 = most satisfied (higher scores indicate greater satisfaction)
Measured: mmediately after the procedure, during recovery (same day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start6 Jan 2025
- Primary completion26 Aug 2025
- Study completion15 Nov 2025
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group randomized controlled trial comparing nasal mask versus nasal cannula oxygenation during gastrointestinal endoscopic procedures performed under target controlled propofol infusion with SedLine monitoring.
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500779
- Sponsor's protocol ID
- 2024/392
- Other IDs
- 2024/392
- Acronym
- NAMSHIC
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2026
- Last updated
- 30 Mar 2026
- 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Nasal Mask and Nasal Cannula Oxygenation During Gastrointestinal Endoscopic Procedures Performed Under Target-Controlled Propofol Infusion Anesthesia With Brain Function Monitoring (SedLine): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07500779
- Acronym / sponsor ID
- NAMSHIC / 2024/392
- Conditions
- Hypoxemia, Conscious Sedation
- Keywords
- Gastrointestinal Endoscopy, Propofol, Target-Controlled Infusion, SedLine, Nasal Mask, Nasal Cannula, Oxygenation, Pulse Oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 30 Mar 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 randomized controlled trial compared the efficacy of a nasal mask versus a standard nasal cannula for oxygen delivery during gastrointestinal endoscopic procedures performed under target controlled propofol infusion anesthesia with SedLine brain function monitoring. Hypoxemia during procedural sedation is a common and clinically relevant event, especially during upper endoscopy and combined procedures. The study aimed to determine whether nasal mask oxygenation reduces hypoxemia compared with nasal cannula oxygenation when sedation depth is guided with electroencephalography based monitoring.
Eligible adult patients undergoing gastrointestinal endoscopic procedures were randomly assigned to receive oxygen either via a nasal mask or via a nasal cannula. Oxygen was administered at a fixed flow rate according to the study protocol. Sedation was provided with target controlled propofol infusion, and SedLine monitoring was used to guide sedation depth throughout the procedure.
The primary outcome was the occurrence of hypoxemia, defined as peripheral oxygen saturation at or below 90 percent. Secondary outcomes included severe hypoxemia, duration of hypoxemia, lowest peripheral oxygen saturation value, need for airway interventions, other adverse events during the procedure, procedure time, recovery time, and operator satisfaction ratings. The study has been completed.
Detailed description
This study was a prospective randomized controlled trial designed to compare two oxygen delivery approaches during gastrointestinal endoscopic procedures performed under target controlled propofol infusion anesthesia with SedLine brain function monitoring. The main objective was to evaluate whether nasal mask oxygenation provides better protection against hypoxemia than standard nasal cannula oxygenation when sedation depth is actively guided with electroencephalography based monitoring.
Adult patients scheduled for gastrointestinal endoscopic procedures were assessed for eligibility and enrolled after appropriate ethical approval and informed consent procedures in accordance with local regulations. Participants were randomly assigned to one of two groups. In the nasal mask group, oxygen was delivered using a nasal mask device. In the nasal cannula group, oxygen was delivered using a standard nasal cannula. Oxygen flow was administered as specified in the protocol. Sedation for all patients was provided with target controlled propofol infusion. SedLine brain function monitoring was used to guide and standardize sedation depth during the procedure to reduce variability related to over sedation or under sedation.
The primary outcome was hypoxemia, defined as peripheral oxygen saturation at or below 90 percent. Secondary outcomes included severe hypoxemia, duration of hypoxemia, the minimum peripheral oxygen saturation recorded, need for airway support or rescue interventions, procedure related adverse events such as cough, hiccup, nausea, vomiting, reflux, aspiration, and laryngospasm, total procedure time, recovery time, and satisfaction ratings by the anesthesiologist and the endoscopist. All outcomes were assessed during the procedure and the immediate recovery period based on standardized definitions in the study protocol. The study has been completed, and the collected data are intended to support evaluation of the comparative effectiveness and safety of nasal mask versus nasal cannula oxygenation in this clinical setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group randomized controlled trial comparing nasal mask versus nasal cannula oxygenation during gastrointestinal endoscopic procedures performed under target controlled propofol infusion with SedLine monitoring.
| Arm | Type | Receives |
|---|---|---|
| Nasal Mask Oxygenation | Experimental | Device: Nasal Mask OxygenationOxygen was delivered via a nasal mask during gastrointestinal endoscopic procedures performed under target controlled propofol infusion with SedLine brain function monitoring. |
| Nasal Cannula Oxygenation | Active comparator | Device: Nasal Cannula OxygenationOxygen was delivered via a standard nasal cannula during gastrointestinal endoscopic procedures performed under target controlled propofol infusion with SedLine brain function monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Scheduled for gastrointestinal endoscopic procedures (upper endoscopy and or colonoscopy) under propofol sedation using target controlled infusion with SedLine monitoring.
- American Society of Anesthesiologists (ASA) physical status I to III.
- Provided written informed consent.
Key exclusion criteria (6 listed)
- Refusal or inability to provide informed consent.
- Known allergy or contraindication to propofol or study related materials.
- Severe cardiorespiratory instability or conditions judged by the investigator to increase procedural risk.
- Pregnancy.
- Requirement for tracheal intubation or general anesthesia at the outset of the procedure.
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 Mask OxygenationOxygen supplementation delivered via a nasal mask at the protocol specified flow rate during the procedure. | Device | Nasal Mask Oxygenation |
| Nasal Cannula OxygenationOxygen supplementation delivered via a standard nasal cannula at the protocol specified flow rate during the procedure. | Device | Nasal Cannula Oxygenation |
Primary outcome
Hypoxemia
Time frame: During the endoscopic procedure and immediate recovery period (from start of sedation to discharge from the recovery area).
Occurrence of hypoxemia defined as peripheral oxygen saturation (SpO2) ≤ 90% during the procedure
8 secondary outcomes
Severe hypoxemia
Time frame: During the endoscopic procedure and immediate recovery period
Duration of hypoxemia
Time frame: During the endoscopic procedure and immediate recovery period.
Minimum SpO2
Time frame: During the endoscopic procedure
Need for airway interventions
Time frame: During the endoscopic procedure and immediate recovery period
Procedure-related adverse events
Time frame: During the endoscopic procedure and immediate recovery period.
Procedure time
Time frame: During the procedure.
Recovery time
Time frame: Immediately after the procedure
Satisfaction ratings
Time frame: mmediately after the procedure, during recovery (same day).
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 30 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mask Oxygenation and Nasal Cannula Oxygenation in people with Hypoxemia and Conscious Sedation, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 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: finished, as of the sponsor's last update on 30 Mar 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?
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?
Hypoxemia (time frame: During the endoscopic procedure and immediate recovery period (from start of sedation to discharge from the recovery area).). 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 30 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.