HypoxemiaNCT06817603
Procedural Oxygen Mask vs. High-flow Nasal Cannula for Hypoxemia Prevention During ERCP
A study testing Procedural Oxygen Mask and High-Flow Nasal Cannula in people with Hypoxemia, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is an imaging procedure that visualizes the drainage ducts of the pancreas, gallbladder, and liver through the use of a duodenoscope and contrast media. By endoscopically identifying the ampulla of Vater, the common bile duct is cannulated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Procedural Oxygen Mask and High-Flow Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2025to 3 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years
- American Society of Anesthesiologists (ASA) classification of 1-2-3
- Patients scheduled for ERCP at Kocaeli City Hospital Endoscopy Unit
Who cannot join
- Refused to participate in the study
- Had an allergy to ketamine, propofol, or midazolam
- Had a BMI >30 kg/m²
- Were pregnant or in the postpartum period
- Had a STOP-BANG score ≥3
- Had a history of intubation within the past 3 months
Show all 12Show fewer
- Had a history of lower respiratory tract infection within the past 3 months
- Had a history of intensive care unit (ICU) admission within the past 3 months
- Had a tracheostomy or a history of tracheostomy placement
- Were oxygen-dependent
- Had lung cancer or a history of lung surgery
- Had asthma, COPD, or interstitial lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Procedural Oxygen Mask vs. High-flow Nasal Cannula for Hypoxemia Prevention During Endoscopic Retrograde Cholangiopancreatography (ERCP): A Randomized Parallel-GroupTrial
Endoscopic retrograde cholangiopancreatography (ERCP) is an imaging procedure that visualizes the drainage ducts of the pancreas, gallbladder, and liver through the use of a duodenoscope and contrast media. By endoscopically identifying the ampulla of Vater, the common bile duct is cannulated. ERCP is also frequently utilized for therapeutic interventions, such as endoscopic sphincterotomy, bile duct stone extraction, stent placement in malignant and benign biliary strictures, and biopsy collection, thus playing a critical role in both the diagnosis and treatment of pancreatobiliary disorders.
ERCP, being more invasive than routine upper endoscopies or colonoscopies, typically necessitates deeper levels of sedation. The procedure is performed in the prone, modified prone, or lateral decubitus position, which increases the risk of hypoxemia and hypoventilation due to upper airway obstruction. Furthermore, endoscopic instruments inserted through the oral cavity limit anesthesiologists' access to the patient's airway, thereby restricting ventilation support during gastrointestinal endoscopy. Ensuring airway stability during sedation is paramount for patient safety and procedural efficacy. Currently, a range of devices, including traditional nasal cannulas, high-flow oxygen masks, and procedural oxygen masks, are employed to provide oxygen support throughout the procedure.
The existing literature includes randomized controlled trials and systematic reviews aimed at preventing hypoxemia during ERCP. Through this study, investigators aim to make a novel contribution to the literature by assessing the effectiveness of a recently introduced procedural oxygen mask.
Read the detailed description
This study aims to compare the efficacy of two oxygen delivery methods-High-Flow Nasal Cannula (HFNC) and Procedural Oxygen Mask (POM)-in preventing hypoxemia during Endoscopic Retrograde Cholangiopancreatography (ERCP). Designed as a randomized, parallel-group, prospective study, participants were assigned to two groups, Group H (HFNC) and Group P (POM), in a 1:1 ratio using computer-assisted random allocation. However, due to the visible differences between the oxygen delivery devices, neither healthcare providers nor patients could be blinded to the randomization.
The study was planned to include 134 patients (67 per group) with a 95% confidence level (1-α) and 90% test power (1-β). To account for an anticipated 10% dropout rate, the total sample size was set at 150 patients.
Throughout the ERCP procedure, all patients will be monitored using pulse oximetry, electrocardiography (ECG), and non-invasive blood pressure monitoring. Capnography will be applied in both groups, and necessary interventions will be carried out by anesthesia specialists if a patient's oxygen saturation falls below 90%. All interventions and events will be meticulously documented. Following the procedure, patients will be monitored in the post-anesthesia care unit (PACU), and those with a Modifiye Alderete score of 10 will be discharged.
The FiO2 will be maintained constant throughout the procedure. Patients will initially receive midazolam at a dose of 0.02 mg/kg, followed by 0.5 mg/kg of ketamine. To ensure adequate sedation, propofol will be administered as an initial bolus dose of 0.5-1.0 mg/kg, with additional boluses of 0.25-0.5 mg/kg every 1-3 minutes as needed to maintain the target sedation level.
The target sedation depth will be 3-4 on the Ramsay Sedation Scale (RSS), and this level will be maintained throughout the procedure. Upon completion, patients will be awakened using verbal and tactile stimuli. Once their RSS reaches 2, they will be transferred to the Post-Anesthesia Care Unit (PACU). Patients will be discharged from the PACU upon achieving a Modified Aldrete Score (MAS) of 10.
Vital signs, procedure durations, and dosages of medications used for each patient will be meticulously recorded. All anesthesia-related decisions during the procedure will be made by the supervising anesthesia specialist.
- Conditions
- Hypoxemia
- Being tested
- Procedural Oxygen Mask, High-Flow Nasal Cannula
- Keywords
- Hypoxemia, Endoscopic Retrograde Cholangiopancreatography, Airway Management
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedural Oxygen MaskDevice
Procedural Oxygen Mask will be used
High-Flow Nasal CannulaDevice
High-Flow Nasal Cannula (HFNC) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Active comparator | Oxygen administered during the endoscopic retrograde cholangiopancreatography (ERCP) procedure will be delivered through a Procedural Oxygen Mask (POM® ELITE MF). The procedural oxygen mask is a device that covers both the mouth and nose to deliver oxygen to the patient. Its reservoir feature increases the concentration of delivered oxygen Receives: Device: Procedural Oxygen Mask |
| Group H | Active comparator | During the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure, oxygen will be delivered through a High-Flow Nasal Cannula (HFNC) device. The high-flow nasal cannula is a device that provides humidified and heated oxygen to the patient via the nasal route. Its high flow rate increases the fraction of inspired oxygen (FiO₂), ensuring more effective oxygenation and reducing dead space ventilation. Receives: Device: High-Flow Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hypoxemia
The incidence of hypoxemia during sedation (defined as SpO2 < 90%). SpO₂ will be continuously measured using a pulse oximeter (GE Healthcare) to monitor and record oxygen saturation levels throughout sedation.
Measured: Continuous SpO2 monitoring will be performed throughout the ERCP procedure
Secondary outcomes (12)
Number of hypoxemia episodes
An episode was recorded when SpO2 dropped below 90% after reaching a level of SpO2 ≥ 90% for 30 seconds. SpO₂ will be continuously measured using a pulse oximeter (GE Healthcare) to monitor and record oxygen saturation levels throughout sedation.
Measured: Continuous SpO2 monitoring will be performed throughout the ERCP procedure
Duration of hypoxemia
Defined as the time taken to reach SpO2 ≥ 90%. SpO₂ will be continuously measured using a pulse oximeter (GE Healthcare) to monitor and record oxygen saturation levels throughout sedation.
Measured: Continuous SpO2 monitoring will be performed throughout the ERCP procedure
Continuous SpO2 monitoring will be performed throughout the ERCP procedure
Minimum SpO2 value observed during the procedure. SpO₂ will be continuously measured using a pulse oximeter (GE Healthcare) to monitor and record oxygen saturation levels throughout sedation.
Measured: Continuous SpO2 monitoring will be performed throughout the ERCP procedure
Frequency of Chin Lift Maneuver
This outcome measure will assess the frequency of the chin lift maneuver performed during the procedure due to hypoxemia
Measured: Interventions related to airway management causing interruptions during the procedure
Frequency of Jaw Thrust Maneuver
This outcome measure will assess the frequency of the Jaw Thrust maneuver performed during the procedure due to hypoxemia
Measured: Interventions related to airway management causing interruptions during the procedure
Frequency of Mask Ventilation
This outcome measure will assess the frequency of the Mask Ventilation performed during the procedure due to hypoxemia
Measured: Interventions related to airway management causing interruptions during the procedure
Frequency of Need for Aspiration
This outcome measure will assess the frequency of need for aspiration performed during the procedure due to hypoxemia
Measured: Interventions related to airway management causing interruptions during the procedure
Frequency of High-Flow Nasal Cannula or Procedural Oxygen Mask (POM) Repositioning
This outcome measure will assess the frequency of Frequency of High-Flow Nasal Cannula or Procedural Oxygen Mask (POM) Repositioning during the procedure due to hypoxemia
Measured: Interventions related to airway management causing interruptions during the procedure
Other potential complications
Other potential complications that may arise during the procedure (hypotension, hypertension, bradycardia, tachycardia, movements that hinder the procedure) (Hypotension is defined as a decrease in the patient's baseline systolic blood pressure of more than 20% or a drop below 90 mm Hg. Hypertension is defined as an increase in the patient's baseline systolic blood pressure of more than 20%. A heart rate below 60 beats per minute is considered bradycardia, while a rate above 100 beats per minute is classified as tachycardia)
Measured: during the procedure
Gastroenterologist satisfaction
a 10-point scoring system was used, where 0 indicates "unmanageable, numerous interruptions or terminated procedure," and 10 indicates "excellent sedation, no interruptions"
Measured: with data reported immediately following the completion of the procedure
Patient satisfaction related to anesthesia
Patient satisfaction related to anesthesia was assessed and recorded before discharge (a scale from 0 to 10 was used, where 0 means "very poor, I would never undergo this procedure again," and 10 means "excellent, I would undergo this procedure again in the same manner
Measured: Data will be recorded until discharge from the PACU, which is expected to occur within up to 2 hours after the procedure
Dry mouth/nose/throat:
Before discharge, patients in the Post-Anesthesia Care Unit (PACU) will be assessed for dry mouth, nose, and throat
Measured: Data will be recorded until discharge from the PACU, which is expected to occur within up to 2 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start7 Mar 2025
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
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 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bedirhan Günel, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817603
- Sponsor's protocol ID
- KSH-ANREA-BG-05
- Status last verified
- Jun 2025
- First submitted
- 31 Jan 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared
Publications
Nay MA, Fromont L, Eugene A, Marcueyz JL, Mfam WS, Baert O, Remerand F, Ravry C, Auvet A, Boulain T. High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial). Br J Anaesth. 2021 Jul;127(1):133-142. doi: 10.1016/j.bja.2021.03.020. Epub 2021 Apr 28.
PubMed 33933271
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Procedural Oxygen Mask vs. High-flow Nasal Cannula for Hypoxemia Prevention During Endoscopic Retrograde Cholangiopancreatography (ERCP): A Randomized Parallel-GroupTrial
- ClinicalTrials.gov ID
- NCT06817603
- Acronym / sponsor ID
- KSH-ANREA-BG-05
- Conditions
- Hypoxemia
- Keywords
- Hypoxemia, Endoscopic Retrograde Cholangiopancreatography, Airway Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 10 Feb 2025 (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.
Endoscopic retrograde cholangiopancreatography (ERCP) is an imaging procedure that visualizes the drainage ducts of the pancreas, gallbladder, and liver through the use of a duodenoscope and contrast media. By endoscopically identifying the ampulla of Vater, the common bile duct is cannulated. ERCP is also frequently utilized for therapeutic interventions, such as endoscopic sphincterotomy, bile duct stone extraction, stent placement in malignant and benign biliary strictures, and biopsy collection, thus playing a critical role in both the diagnosis and treatment of pancreatobiliary disorders.
ERCP, being more invasive than routine upper endoscopies or colonoscopies, typically necessitates deeper levels of sedation. The procedure is performed in the prone, modified prone, or lateral decubitus position, which increases the risk of hypoxemia and hypoventilation due to upper airway obstruction. Furthermore, endoscopic instruments inserted through the oral cavity limit anesthesiologists' access to the patient's airway, thereby restricting ventilation support during gastrointestinal endoscopy. Ensuring airway stability during sedation is paramount for patient safety and procedural efficacy. Currently, a range of devices, including traditional nasal cannulas, high-flow oxygen masks, and procedural oxygen masks, are employed to provide oxygen support throughout the procedure.
The existing literature includes randomized controlled trials and systematic reviews aimed at preventing hypoxemia during ERCP. Through this study, investigators aim to make a novel contribution to the literature by assessing the effectiveness of a recently introduced procedural oxygen mask.
Detailed description
This study aims to compare the efficacy of two oxygen delivery methods-High-Flow Nasal Cannula (HFNC) and Procedural Oxygen Mask (POM)-in preventing hypoxemia during Endoscopic Retrograde Cholangiopancreatography (ERCP). Designed as a randomized, parallel-group, prospective study, participants were assigned to two groups, Group H (HFNC) and Group P (POM), in a 1:1 ratio using computer-assisted random allocation. However, due to the visible differences between the oxygen delivery devices, neither healthcare providers nor patients could be blinded to the randomization.
The study was planned to include 134 patients (67 per group) with a 95% confidence level (1-α) and 90% test power (1-β). To account for an anticipated 10% dropout rate, the total sample size was set at 150 patients.
Throughout the ERCP procedure, all patients will be monitored using pulse oximetry, electrocardiography (ECG), and non-invasive blood pressure monitoring. Capnography will be applied in both groups, and necessary interventions will be carried out by anesthesia specialists if a patient's oxygen saturation falls below 90%. All interventions and events will be meticulously documented. Following the procedure, patients will be monitored in the post-anesthesia care unit (PACU), and those with a Modifiye Alderete score of 10 will be discharged.
The FiO2 will be maintained constant throughout the procedure. Patients will initially receive midazolam at a dose of 0.02 mg/kg, followed by 0.5 mg/kg of ketamine. To ensure adequate sedation, propofol will be administered as an initial bolus dose of 0.5-1.0 mg/kg, with additional boluses of 0.25-0.5 mg/kg every 1-3 minutes as needed to maintain the target sedation level.
The target sedation depth will be 3-4 on the Ramsay Sedation Scale (RSS), and this level will be maintained throughout the procedure. Upon completion, patients will be awakened using verbal and tactile stimuli. Once their RSS reaches 2, they will be transferred to the Post-Anesthesia Care Unit (PACU). Patients will be discharged from the PACU upon achieving a Modified Aldrete Score (MAS) of 10.
Vital signs, procedure durations, and dosages of medications used for each patient will be meticulously recorded. All anesthesia-related decisions during the procedure will be made by the supervising anesthesia specialist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | Active comparator | Device: Procedural Oxygen MaskOxygen administered during the endoscopic retrograde cholangiopancreatography (ERCP) procedure will be delivered through a Procedural Oxygen Mask (POM® ELITE MF). The procedural oxygen mask is a device that covers both the mouth and nose to deliver oxygen to the patient. Its reservoir feature increases the concentration of delivered oxygen |
| Group H | Active comparator | Device: High-Flow Nasal CannulaDuring the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure, oxygen will be delivered through a High-Flow Nasal Cannula (HFNC) device. The high-flow nasal cannula is a device that provides humidified and heated oxygen to the patient via the nasal route. Its high flow rate increases the fraction of inspired oxygen (FiO₂), ensuring more effective oxygenation and reducing dead space ventilation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-75 years
- American Society of Anesthesiologists (ASA) classification of 1-2-3
- Patients scheduled for ERCP at Kocaeli City Hospital Endoscopy Unit
Key exclusion criteria (12 listed)
- Refused to participate in the study
- Had an allergy to ketamine, propofol, or midazolam
- Had a BMI >30 kg/m²
- Were pregnant or in the postpartum period
- Had a STOP-BANG score ≥3
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 |
|---|---|---|
| Procedural Oxygen MaskProcedural Oxygen Mask will be used | Device | Group P |
| High-Flow Nasal CannulaHigh-Flow Nasal Cannula (HFNC) will be used. | Device | Group H |
Primary outcome
incidence of hypoxemia
Time frame: Continuous SpO2 monitoring will be performed throughout the ERCP procedure
The incidence of hypoxemia during sedation (defined as SpO2 < 90%). SpO₂ will be continuously measured using a pulse oximeter (GE Healthcare) to monitor and record oxygen saturation levels throughout sedation.
12 secondary outcomes
Number of hypoxemia episodes
Time frame: Continuous SpO2 monitoring will be performed throughout the ERCP procedure
Duration of hypoxemia
Time frame: Continuous SpO2 monitoring will be performed throughout the ERCP procedure
Continuous SpO2 monitoring will be performed throughout the ERCP procedure
Time frame: Continuous SpO2 monitoring will be performed throughout the ERCP procedure
Frequency of Chin Lift Maneuver
Time frame: Interventions related to airway management causing interruptions during the procedure
Frequency of Jaw Thrust Maneuver
Time frame: Interventions related to airway management causing interruptions during the procedure
Frequency of Mask Ventilation
Time frame: Interventions related to airway management causing interruptions during the procedure
Frequency of Need for Aspiration
Time frame: Interventions related to airway management causing interruptions during the procedure
Frequency of High-Flow Nasal Cannula or Procedural Oxygen Mask (POM) Repositioning
Time frame: Interventions related to airway management causing interruptions during the procedure
Other potential complications
Time frame: during the procedure
Gastroenterologist satisfaction
Time frame: with data reported immediately following the completion of the procedure
Patient satisfaction related to anesthesia
Time frame: Data will be recorded until discharge from the PACU, which is expected to occur within up to 2 hours after the procedure
Dry mouth/nose/throat:
Time frame: Data will be recorded until discharge from the PACU, which is expected to occur within up to 2 hours after the procedure
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 4 Jun 2025.
- Background: PubMed 33933271Nay MA, Fromont L, Eugene A, Marcueyz JL, Mfam WS, Baert O, Remerand F, Ravry C, Auvet A, Boulain T. High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial). Br J Anaesth. 2021 Jul;127(1):133-142. doi: 10.1016/j.bja.2021.03.020. Epub 2021 Apr 28.
- Individual participant dataSharing planned: No. The data will not be shared
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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 Procedural Oxygen Mask and High-Flow Nasal Cannula in people with Hypoxemia, run by Kocaeli City 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 3 inclusion and 12 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 4 Jun 2025. 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?
incidence of hypoxemia (time frame: Continuous SpO2 monitoring will be performed throughout the ERCP 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 NCT06817603, 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 4 Jun 2025.