High-flow Nasal CannulaNCT04184089
High Flow Nasal Cannula in Patients Undergoing ERCP Retrograde Cholangiopancreatography With Intravenous Sedation.
A study testing High flow nasal cannula (15 L/m), High flow nasal cannula (30 L/m) and High flow nasal cannula (60 L/m) in people with High-flow Nasal Cannula and Intravenous Sedation, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The aim of the current study is to compare the incidence of oxygen desaturation in patients receiving HFNC at different flow rates compared to conventional oxygen therapy via a simple cannula during ERCP. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- High-flow Nasal Cannula, Intravenous Sedation
- What is being tested?
- High flow nasal cannula (15 L/m), High flow nasal cannula (30 L/m) and High flow nasal cannula (60 L/m)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 25 Aug 2020to 17 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient able to give consent.
- Patient undergoing deep sedation.
- Patient undergoing ERCP procedure with no restrictions on the duration of the procedure.
- Age > 18 years
- Patients with BMI < 40 kg/m2
Who cannot join
- Patient unable to give consent
- Patient refusal to participate
- Patients undergoing general anesthesia
- age less than 18 years old
- Patients with severe heart failure (EF<30%)
- Morbidly obese Patients with BMI > 40 kg/m2
Show all 12Show fewer
- Patients with sleep apnea
- Claustrophobia
- Risk of aspiration due to severe reflux
- Facial injury, facial malformation
- Nasal defects/obstruction
- ASA 4 patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography With Intravenous Sedation.
The aim of the current study is to compare the incidence of oxygen desaturation in patients receiving HFNC at different flow rates compared to conventional oxygen therapy via a simple cannula during ERCP. Secondary outcomes include lowest average observed oxygen saturation (SpO2), snoring classification scores and satisfaction levels of both patients and gastroenterologists.
Participants will be randomized to 3 groups: G0 will receive a 5 l/ min flow rate through a nasal cannula at and FiO2 of 40 %, G1 will receive a 15 l/ min flow rate and FiO2 of 40% and G2: will receive a 60L/min flow rate and FiO2 of 40%.
Read the detailed description
High flow nasal cannula provides adequate oxygenation in patients with compromised pulmonary function. Very few studies in the literature addressed its use with IV sedation in the OR. Successful application of High Flow nasal cannula in intravenous deep sedation cases in the OR will benefit in the reduction of airway manipulation and side effects from general anesthesia.
The aim of the current study is to compare the incidence of oxygen desaturation in patients receiving HFNC at different flow rates compared to conventional oxygen therapy via a simple cannula during ERCP. Secondary outcomes include lowest average observed oxygen saturation (SpO2), snoring classification scores and satisfaction levels of both patients and gastroenterologists.
A total of 60 patients undergoing ERCP will be equally randomized to 3 groups:
G0: will receive a 5 l/ min flow rate through a nasal cannula at and FiO2 of 40 %, G1: will receive a 15 l/ min flow rate and FiO2 of 40% and G2: will receive a 60L/min flow rate and FiO2 of 40%.
The three groups' intra-procedure and outcome parameters and variables will be compared. Statistical comparison will be made using the ANOVA, Student's t-test, and Chi-squared test. Level of statistical significance will be considered at p<0.05. ANOVA test will be performed to compare the different means between the four groups. Minimum and maximum 3 of 17 values will be recorded for each value in all 3 groups. A two sided P value of less than 0.05 will be considered statistically significant.
- Conditions
- High-flow Nasal Cannula, Intravenous Sedation
- Being tested
- High flow nasal cannula (15 L/m), High flow nasal cannula (30 L/m), High flow nasal cannula (60 L/m)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannula (15 L/m)Device
nasal cannula at a flow rate of 15 l/min and FiO2 of 40%
High flow nasal cannula (30 L/m)Device
nasal cannula at a flow rate of 30l/min and FiO2 of 40%
High flow nasal cannula (60 L/m)Device
nasal cannula at flow rate of 60L/min. Oxygen supplementation will be at an FiO2 of 40%.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | High flow rate of 5 L/min and FiO2 of 40% Receives: Device: High flow nasal cannula (15 L/m) |
| Group 15 liter | Experimental | Nasal cannula at flow rate of 15 L/min and FiO2 of 40% Receives: Device: High flow nasal cannula (30 L/m) |
| Group 60 liter | Experimental | Nasal cannula at flow rate of 60 L/min and FiO2 of 40% Receives: Device: High flow nasal cannula (60 L/m) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation
Desaturation (SpO2≤95%) or a drop of more than 5% from baseline SpO2
Measured: During the surgery
Secondary outcomes (7)
Lowest SpO2
Lowest SpO2 (%)
Measured: During procedure
Mean SpO2
Mean SpO2 (%)
Measured: During procedure
Duration of the procedure
Duration of the procedure measured in minutes
Measured: During procedure
Snoring status
Snoring status measured as Yes/No
Measured: During procedure
Snoring snore
snoring score assessed using a subjective snoring classification developed at Stanford on a scale from 0 to 10
Measured: During procedure
Gastroenterologists' satisfaction
Gastroenterologists' satisfaction measured using a 5-point Likert scale
Measured: During procedure
Patients' satisfaction
Patients' satisfaction measured using a 5-point Likert scale
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start25 Aug 2020
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-flow Nasal CannulaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Rouphael, American University of Beirut Medical Center
- Investigators
- Christian Rouphael, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184089
- Sponsor's protocol ID
- ANES.CE.01
- Status last verified
- Dec 2025
- First submitted
- 11 Oct 2019
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography With Intravenous Sedation.
- ClinicalTrials.gov ID
- NCT04184089
- Acronym / sponsor ID
- ANES.CE.01
- Conditions
- High-flow Nasal Cannula, Intravenous Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 3 Dec 2019 (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.
The aim of the current study is to compare the incidence of oxygen desaturation in patients receiving HFNC at different flow rates compared to conventional oxygen therapy via a simple cannula during ERCP. Secondary outcomes include lowest average observed oxygen saturation (SpO2), snoring classification scores and satisfaction levels of both patients and gastroenterologists.
Participants will be randomized to 3 groups: G0 will receive a 5 l/ min flow rate through a nasal cannula at and FiO2 of 40 %, G1 will receive a 15 l/ min flow rate and FiO2 of 40% and G2: will receive a 60L/min flow rate and FiO2 of 40%.
Detailed description
High flow nasal cannula provides adequate oxygenation in patients with compromised pulmonary function. Very few studies in the literature addressed its use with IV sedation in the OR. Successful application of High Flow nasal cannula in intravenous deep sedation cases in the OR will benefit in the reduction of airway manipulation and side effects from general anesthesia.
The aim of the current study is to compare the incidence of oxygen desaturation in patients receiving HFNC at different flow rates compared to conventional oxygen therapy via a simple cannula during ERCP. Secondary outcomes include lowest average observed oxygen saturation (SpO2), snoring classification scores and satisfaction levels of both patients and gastroenterologists.
A total of 60 patients undergoing ERCP will be equally randomized to 3 groups:
G0: will receive a 5 l/ min flow rate through a nasal cannula at and FiO2 of 40 %, G1: will receive a 15 l/ min flow rate and FiO2 of 40% and G2: will receive a 60L/min flow rate and FiO2 of 40%.
The three groups' intra-procedure and outcome parameters and variables will be compared. Statistical comparison will be made using the ANOVA, Student's t-test, and Chi-squared test. Level of statistical significance will be considered at p<0.05. ANOVA test will be performed to compare the different means between the four groups. Minimum and maximum 3 of 17 values will be recorded for each value in all 3 groups. A two sided P value of less than 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Device: High flow nasal cannula (15 L/m)High flow rate of 5 L/min and FiO2 of 40% |
| Group 15 liter | Experimental | Device: High flow nasal cannula (30 L/m)Nasal cannula at flow rate of 15 L/min and FiO2 of 40% |
| Group 60 liter | Experimental | Device: High flow nasal cannula (60 L/m)Nasal cannula at flow rate of 60 L/min and FiO2 of 40% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient able to give consent.
- Patient undergoing deep sedation.
- Patient undergoing ERCP procedure with no restrictions on the duration of the procedure.
- Age > 18 years
- Patients with BMI < 40 kg/m2
Key exclusion criteria (12 listed)
- Patient unable to give consent
- Patient refusal to participate
- Patients undergoing general anesthesia
- age less than 18 years old
- Patients with severe heart failure (EF<30%)
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 |
|---|---|---|
| High flow nasal cannula (15 L/m)nasal cannula at a flow rate of 15 l/min and FiO2 of 40% | Device | Control group |
| High flow nasal cannula (30 L/m)nasal cannula at a flow rate of 30l/min and FiO2 of 40% | Device | Group 15 liter |
| High flow nasal cannula (60 L/m)nasal cannula at flow rate of 60L/min. Oxygen supplementation will be at an FiO2 of 40%. | Device | Group 60 liter |
Primary outcome
Desaturation
Time frame: During the surgery
Desaturation (SpO2≤95%) or a drop of more than 5% from baseline SpO2
7 secondary outcomes
Lowest SpO2
Time frame: During procedure
Mean SpO2
Time frame: During procedure
Duration of the procedure
Time frame: During procedure
Snoring status
Time frame: During procedure
Snoring snore
Time frame: During procedure
Gastroenterologists' satisfaction
Time frame: During procedure
Patients' satisfaction
Time frame: During 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 19 Dec 2025.
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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.
Christian Rouphael, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula (15 L/m), High flow nasal cannula (30 L/m) and High flow nasal cannula (60 L/m) in people with High-flow Nasal Cannula and Intravenous Sedation, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 5 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 19 Dec 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 Lebanon. 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?
Desaturation (time frame: During the surgery). 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 19 Dec 2025.