HypoxemiaNCT06681558
Procedural Oxygen Mask vs. Nasal Cannula for Hypoxemia Prevention During Endoscopic Retrograde Cholangiopancreatography
A study testing Group Nasal Cannula and Group Procedural Oxygen Mask 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?
- Group Nasal Cannula and Group Procedural Oxygen Mask
- 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
- 12 Nov 2024to 6 Feb 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
- Patients who refuse to participate in the study
- Patients with allergies to ketamine, propofol, or midazolam
- Patients diagnosed with psychiatric disorders
- Patients with a body mass index (BMI) >30 kg/m²
- Patients with cognitive impairment, dementia, or communication issues
- Pregnant patients or those in the postpartum period
Show all 17Show fewer
- Patients diagnosed with sleep apnea syndrome
- History of intubation within the last 3 months
- History of lower respiratory tract infection within the last 3 months
- History of intensive care unit admission within the last 3 months
- Patients with a tracheostomy
- Patients with a history of tracheostomy
- Patients who are oxygen-dependent due to a medical condition
- Patients with lung cancer or who have undergone surgery on their lungs
- Patients with asthma, COPD, or interstitial lung diseases
- Patients with uncontrolled hypertension (BP >180/110)
- Patients receiving home care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Procedural Oxygen Mask vs. Conventional Nasal Cannula for Hypoxemia Prevention During Endoscopic Retrograde Cholangiopancreatography (ERCP): A Randomized Controlled Trial
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 routinely 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 different oxygen delivery methods (Nasal Cannula [NC] and Procedural Oxygen Mask [POM]) in preventing the incidence of hypoxemia during Endoscopic Retrograde Cholangiopancreatography (ERCP). Designed as a randomized controlled prospective study, participants were assigned into two groups, Group N (NC) and Group P (POM), at a 1:1 ratio through randomization. The randomization was performed using computer-assisted random allocation; however, due to the visual differences in the oxygen delivery devices, neither healthcare providers nor patients could be blinded to the randomization results. A power analysis conducted to establish a statistical power of 80% and an alpha level of 0.05 indicated that a total of 140 patients, with 70 patients in each group, should be included in the study. Considering potential dropouts, 150 patients will be included in the study This evaluation ensures that an adequate sample size is obtained to detect a significant difference in the incidence of hypoxemia.
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 Post-Anesthesia Discharge Scoring System (PADSS) score of 9 or higher will be discharged.
Anesthesia Management The oxygen flow rate will be maintained constant throughout the procedure. Initially, patients will receive midazolam at a dose of 0.02 mg/kg, followed by 0.3 mg/kg of ketamine. To ensure sedation, propofol will be administered as an initial bolus dose of 0.5-1.0 mg/kg; further bolus doses of 0.25-0.5 mg/kg will be given every 1-3 minutes to maintain the desired sedation level. The target sedation level will be aimed at 3-4 on the Ramsay Sedation Scale (RSS), and these target values will be preserved during the procedure. Upon completion of the procedure, patients will be awakened using verbal and tactile stimuli; once the RSS reaches 2, they will be transferred to the PACU. In the PACU, patients will be discharged if they achieve a PADSS score of 9 or above.
Oxygen Reserve Index (ORi) measurement will performed on all patients. The ORi value will measured and recorded at the plateau level during the preoxygenation stage (as the baseline), immediately after the start of the procedure, at the end of the procedure, and the highest ORi value measured throughout the procedure
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
- Group Nasal Cannula, Group Procedural Oxygen Mask
- Keywords
- Hypoxemia, Endoscopic Retrograde Cholangiopancreatography, Airway Management, Sedation
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Nasal CannulaDevice
Oxygen administered during the endoscopic retrograde cholangiopancreatography (ERCP) procedure will be delivered through a conventional oxygen mask.
The nasal cannula is a device that provides oxygen to patients through the nasal passages.
Group Procedural Oxygen MaskDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group Nasal Cannula | Active comparator | Oxygen will be administered to this group via a conventional nasal cannula. Receives: Device: Group Nasal Cannula |
| Group Procedural Oxygen Mask | Active comparator | Oxygen will be administered to this group via a Procedural Oxygen Mask. Receives: Device: Group Procedural Oxygen Mask |
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 (16)
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
Minimum SpO2 value observed during the 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
Oxygen Reserve Index (as the baseline)
The Oxygen Reserve Index (ORi) value will be measured at the plateau level during the preoxygenation stage (as the baseline)
Measured: Continuous Oxygen Reserve Index monitoring will be performed after prepreoxygenation
Oxygen Reserve Index (immediately after the start of the procedure)
Oxygen Reserve Index (immediately after the start of the procedure) value will bemeasured
Measured: Continuous Oxygen Reserve Index monitoring will be performed throughout the ERCP procedure
Oxygen Reserve Index (at the end of the procedure)
Oxygen Reserve Index (at the end of the procedure) value will be measured
Measured: Continuous Oxygen Reserve Index monitoring will be performed throughout the ERCP procedure
Oxygen Reserve Index (highest ORi value will be measured)
Oxygen Reserve Index (highest ORi value will be measured) value will be measured
Measured: Continuous Oxygen Reserve Index monitoring will be performed throughout the ERCP procedure
airway management
This measure will assess the frequency and types of airway management interventions performed during the procedure that result in interruptions. The specific interventions include chin lift, jaw thrust, mask ventilation, need for aspiration, and repositioning of the nasal cannula or Procedural Oxygen Mask (POM). Data will be collected through direct observation and recorded in the procedural notes, capturing the number of times each intervention was required.
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
Number of Participants with Early Termination of Procedure Due to Sedation
This measure will track the number of participants for whom the procedure was terminated early as a result of sedation-related factors.
Measured: during the procedure
ERCP duration
defined as the time from the start of the procedure until the gastroscope is completely removed.
Measured: up to 60 minutes (or the estimated average duration of the procedure)
Recovery time
defined as the time from the administration of the first anesthetic until the procedure is completely finished and Ramsey Sedation Scale (RSS) reaches 2.
Measured: up to a maximum of 90 minutes (or the estimated average recovery time for the procedure)
Discharge time
defined as the time from the removal of the gastroscope until MPADS is 9 or above
Measured: assessed during the recovery period, up to a maximum of 120 minutes (or the estimated average time for the procedure recovery)
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.
Postoperative nausea, vomiting, pain, aspiration, and other potential complications
Postoperative nausea, vomiting, pain, aspiration, and other potential complications
Measured: Data will be recorded until discharge from the PACU, which is expected to occur within up to 2 hours after 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."
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start12 Nov 2024
- Primary completion6 Feb 2025
- Study completion6 Feb 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
- Investigators
- BEDİRHAN GÜNEL, MD, Study chair, Kocaeli City HospitalAYŞE ŞENCAN, MD, Principal investigator, Kocaeli City HospitalYASEMİN Y. TAVŞANOĞLU, MD, Principal investigator, Kocaeli City HospitalZEKİ İSLAMOĞLU, MD, Principal investigator, Kocaeli City HospitalAHMET YÜKSEK, ASSOC. PROF, Principal investigator, Kocaeli City HospitalMEHMET YILMAZ, ASSOC.PROF, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681558
- Sponsor's protocol ID
- KSH-ANREA-BG-03
- Status last verified
- Mar 2026
- First submitted
- 31 Oct 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal data and study data will not be shared.
Publications
Gunel B, Sencan A, Tavsanoglu ZY, Cevik T, Atli E, Islamoglu Z, Yuksek A, Yilmaz M. Comparison of Procedural Oxygen Mask Versus Conventional Nasal Cannula for Hypoxemia Prevention During Endoscopic Retrograde Cholangiopancreatography: A Randomized Controlled Trial. Dig Dis Sci. 2025 Dec;70(12):4281-4291. doi: 10.1007/s10620-025-09264-9. Epub 2025 Jul 30.
PubMed 40736944
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Procedural Oxygen Mask vs. Conventional Nasal Cannula for Hypoxemia Prevention During Endoscopic Retrograde Cholangiopancreatography (ERCP): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06681558
- Acronym / sponsor ID
- KSH-ANREA-BG-03
- Conditions
- Hypoxemia
- Keywords
- Hypoxemia, Endoscopic Retrograde Cholangiopancreatography, Airway Management, Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 8 Nov 2024 (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 routinely 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 different oxygen delivery methods (Nasal Cannula [NC] and Procedural Oxygen Mask [POM]) in preventing the incidence of hypoxemia during Endoscopic Retrograde Cholangiopancreatography (ERCP). Designed as a randomized controlled prospective study, participants were assigned into two groups, Group N (NC) and Group P (POM), at a 1:1 ratio through randomization. The randomization was performed using computer-assisted random allocation; however, due to the visual differences in the oxygen delivery devices, neither healthcare providers nor patients could be blinded to the randomization results. A power analysis conducted to establish a statistical power of 80% and an alpha level of 0.05 indicated that a total of 140 patients, with 70 patients in each group, should be included in the study. Considering potential dropouts, 150 patients will be included in the study This evaluation ensures that an adequate sample size is obtained to detect a significant difference in the incidence of hypoxemia.
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 Post-Anesthesia Discharge Scoring System (PADSS) score of 9 or higher will be discharged.
Anesthesia Management The oxygen flow rate will be maintained constant throughout the procedure. Initially, patients will receive midazolam at a dose of 0.02 mg/kg, followed by 0.3 mg/kg of ketamine. To ensure sedation, propofol will be administered as an initial bolus dose of 0.5-1.0 mg/kg; further bolus doses of 0.25-0.5 mg/kg will be given every 1-3 minutes to maintain the desired sedation level. The target sedation level will be aimed at 3-4 on the Ramsay Sedation Scale (RSS), and these target values will be preserved during the procedure. Upon completion of the procedure, patients will be awakened using verbal and tactile stimuli; once the RSS reaches 2, they will be transferred to the PACU. In the PACU, patients will be discharged if they achieve a PADSS score of 9 or above.
Oxygen Reserve Index (ORi) measurement will performed on all patients. The ORi value will measured and recorded at the plateau level during the preoxygenation stage (as the baseline), immediately after the start of the procedure, at the end of the procedure, and the highest ORi value measured throughout the procedure
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 Nasal Cannula | Active comparator | Device: Group Nasal CannulaOxygen will be administered to this group via a conventional nasal cannula. |
| Group Procedural Oxygen Mask | Active comparator | Device: Group Procedural Oxygen MaskOxygen will be administered to this group via a Procedural Oxygen Mask. |
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 (17 listed)
- Patients who refuse to participate in the study
- Patients with allergies to ketamine, propofol, or midazolam
- Patients diagnosed with psychiatric disorders
- Patients with a body mass index (BMI) >30 kg/m²
- Patients with cognitive impairment, dementia, or communication issues
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 |
|---|---|---|
| Group Nasal CannulaOxygen administered during the endoscopic retrograde cholangiopancreatography (ERCP) procedure will be delivered through a conventional oxygen mask. The nasal cannula is a device that provides oxygen to patients through the nasal passages. | Device | Group Nasal Cannula |
| Group 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 | Device | Group Procedural Oxygen Mask |
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.
16 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
Minimum SpO2 value observed during the procedure
Time frame: Continuous SpO2 monitoring will be performed throughout the ERCP procedure
Oxygen Reserve Index (as the baseline)
Time frame: Continuous Oxygen Reserve Index monitoring will be performed after prepreoxygenation
Oxygen Reserve Index (immediately after the start of the procedure)
Time frame: Continuous Oxygen Reserve Index monitoring will be performed throughout the ERCP procedure
Oxygen Reserve Index (at the end of the procedure)
Time frame: Continuous Oxygen Reserve Index monitoring will be performed throughout the ERCP procedure
Oxygen Reserve Index (highest ORi value will be measured)
Time frame: Continuous Oxygen Reserve Index monitoring will be performed throughout the ERCP procedure
airway management
Time frame: Interventions related to airway management causing interruptions during the procedure
Other potential complications
Time frame: during the procedure
Number of Participants with Early Termination of Procedure Due to Sedation
Time frame: during the procedure
ERCP duration
Time frame: up to 60 minutes (or the estimated average duration of the procedure)
Recovery time
Time frame: up to a maximum of 90 minutes (or the estimated average recovery time for the procedure)
Discharge time
Time frame: assessed during the recovery period, up to a maximum of 120 minutes (or the estimated average time for the procedure recovery)
Gastroenterologist satisfaction
Time frame: with data reported immediately following the completion of the procedure.
Postoperative nausea, vomiting, pain, aspiration, and other potential complications
Time frame: Data will be recorded until discharge from the PACU, which is expected to occur within up to 2 hours after 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."
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 5 Mar 2026.
- Derived from this study: PubMed 40736944Gunel B, Sencan A, Tavsanoglu ZY, Cevik T, Atli E, Islamoglu Z, Yuksek A, Yilmaz M. Comparison of Procedural Oxygen Mask Versus Conventional Nasal Cannula for Hypoxemia Prevention During Endoscopic Retrograde Cholangiopancreatography: A Randomized Controlled Trial. Dig Dis Sci. 2025 Dec;70(12):4281-4291. doi: 10.1007/s10620-025-09264-9. Epub 2025 Jul 30.
- Individual participant dataSharing planned: No. Personal data and study 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.
BEDİRHAN GÜNEL, MD study chair
Kocaeli City Hospital
AYŞE ŞENCAN, MD principal investigator
Kocaeli City Hospital
YASEMİN Y. TAVŞANOĞLU, MD principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Nasal Cannula and Group Procedural Oxygen Mask 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 17 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 5 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?
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 NCT06681558, 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 5 Mar 2026.