Patient Population Submitted to ERCPHFSNCT04082208
High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) HF-study
A study testing High Flow nasal cannula and Low Flow nasal cannula in people with Patient Population Submitted to ERCP, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The expected results with this study are that high flow devices (LAF) provide adequate respiratory support during the performance of ERCP under deep sedation, reducing episodes of desaturation, hypoventilation and airway obstruction compared to low flow devices ( nasal glasses). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Population Submitted to ERCP
- What is being tested?
- High Flow nasal cannula and Low Flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2020to 1 Jan 2021
- 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
- Patients Age over ≥18 years. Willing to participate
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clinic Hospital (Endoscopy Unit)
Barcelona, 08036
JULIA MARTINEZ, dr, +34932275558 ext. 5558, jocon@clinic.cat
About this study
Official title: Use of High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) Under Sedation. Comparative, Randomized Study of Two Health Products Approved by the Community
The expected results with this study are that high flow devices (LAF) provide adequate respiratory support during the performance of ERCP under deep sedation, reducing episodes of desaturation, hypoventilation and airway obstruction compared to low flow devices ( nasal glasses).
Read the detailed description
Deep sedation performed during the ERCP technique associates an increased risk of decrease in Sat02%, hypercapnia and airway obstruction with consequences ranging from interruption or suspension of the technique to complications that may put the patient's life at risk .
High flow devices (HF) due to the pressurization capacity of the airway and the reduction of anatomical dead space will favor a better gas exchange compared to low flow devices (LF), which will manifest clinically with a reduction in episodes of decrease of Sat02% and a decrease in carbon dioxide levels.
The main objective of the study is to demonstrate that the use of high flow devices (HF) decreases the episodes of desaturation (defined as Sat02 ≤ 90% measured through pulse oximetry) that occur during the performance of ERCP under deep sedation compared to Low flow devices (LF) with equal Inspiratory oxygen fraction (Fi02) in both cases.
The expected results with this study are that high flow devices (LAF) provide adequate respiratory support during the performance of ERCP under deep sedation, reducing episodes of desaturation, hypoventilation and airway obstruction compared to low flow devices ( nasal glasses).
- Conditions
- Patient Population Submitted to ERCP
- Being tested
- High Flow nasal cannula, Low Flow nasal cannula
- Keywords
- ERCP, High Flow nasal cannula, deep sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow nasal cannulaDevice
Administration of high flow nasal cannula during ERCP procedure
Low Flow nasal cannulaDevice
Administration of low flow nasal cannula during ERCP procedure: standard care
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | High Flow nasal cannula (HF) Receives: Device: High Flow nasal cannula |
| Standar Care Group | Active comparator | Standar Care: low flow device (LF) Receives: Device: Low Flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation during ERCP
Demonstrate that the use of high flow devices (HF) decreases episodes of desaturation (defined as Sat02 ≤ 90% measured by pulse oximetry) that occur during the performance of ERCP under deep sedation compared to low flow devices ( LF).
Measured: 2 years
Secondary outcomes (1)
CO2 during ERCP
The use of HF decreases the CO2 levels measured through transcutaneous CO2 (PtcCO2) compared to conventional oxygen therapy (LF)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Feb 2020
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Population Submitted to ERCPStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Model description
- Unicentre controlled clinical trial, unmasked, performed in the Digestive Endoscopy Unit of the Hospital Clínic. 172 patients submitted to Endoscopic Retrograde Cholangiography who agree to participate in the study will be included consecutively and randomly. Patients will be randomized into two groups: Control group: low flow device (nasal glasses) and High Flow device group (LAF).
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JULIA MARTÍNEZ OCÓN, Hospital Clinic of Barcelona
- Investigators
- Julia Martinez Ocon, Dr, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082208
- Sponsor's protocol ID
- High-Flow study-172
- Acronym
- HFS
- Status last verified
- Feb 2020
- First submitted
- 4 Sep 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) Under Sedation. Comparative, Randomized Study of Two Health Products Approved by the Community
- ClinicalTrials.gov ID
- NCT04082208
- Acronym / sponsor ID
- HFS / High-Flow study-172
- Conditions
- Patient Population Submitted to ERCP
- Keywords
- ERCP, High Flow nasal cannula, deep sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 9 Sep 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 expected results with this study are that high flow devices (LAF) provide adequate respiratory support during the performance of ERCP under deep sedation, reducing episodes of desaturation, hypoventilation and airway obstruction compared to low flow devices ( nasal glasses).
Detailed description
Deep sedation performed during the ERCP technique associates an increased risk of decrease in Sat02%, hypercapnia and airway obstruction with consequences ranging from interruption or suspension of the technique to complications that may put the patient's life at risk .
High flow devices (HF) due to the pressurization capacity of the airway and the reduction of anatomical dead space will favor a better gas exchange compared to low flow devices (LF), which will manifest clinically with a reduction in episodes of decrease of Sat02% and a decrease in carbon dioxide levels.
The main objective of the study is to demonstrate that the use of high flow devices (HF) decreases the episodes of desaturation (defined as Sat02 ≤ 90% measured through pulse oximetry) that occur during the performance of ERCP under deep sedation compared to Low flow devices (LF) with equal Inspiratory oxygen fraction (Fi02) in both cases.
The expected results with this study are that high flow devices (LAF) provide adequate respiratory support during the performance of ERCP under deep sedation, reducing episodes of desaturation, hypoventilation and airway obstruction compared to low flow devices ( nasal glasses).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unicentre controlled clinical trial, unmasked, performed in the Digestive Endoscopy Unit of the Hospital Clínic. 172 patients submitted to Endoscopic Retrograde Cholangiography who agree to participate in the study will be included consecutively and randomly. Patients will be randomized into two groups: Control group: low flow device (nasal glasses) and High Flow device group (LAF).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: High Flow nasal cannulaHigh Flow nasal cannula (HF) |
| Standar Care Group | Active comparator | Device: Low Flow nasal cannulaStandar Care: low flow device (LF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients Age over ≥18 years. Willing to participate
Key exclusion criteria (1 listed)
- None
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 cannulaAdministration of high flow nasal cannula during ERCP procedure | Device | Intervention Group |
| Low Flow nasal cannulaAdministration of low flow nasal cannula during ERCP procedure: standard care | Device | Standar Care Group |
Primary outcome
Desaturation during ERCP
Time frame: 2 years
Demonstrate that the use of high flow devices (HF) decreases episodes of desaturation (defined as Sat02 ≤ 90% measured by pulse oximetry) that occur during the performance of ERCP under deep sedation compared to low flow devices ( LF).
1 secondary outcome
CO2 during ERCP
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
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.
Julia Martinez Ocon, Dr principal investigator
Hospital Clinic of Barcelona
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 and Low Flow nasal cannula in people with Patient Population Submitted to ERCP, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Feb 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Martinez Ocon, Dr (+34639987302, jocon@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desaturation during ERCP (time frame: 2 years). 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 11 Feb 2020.