ObeseNCT04912102
HFNO Versus Nasal CPAP in Obese Patients Undergoing Deep Sedation for ERCP
A study testing high flow nasal oxygen device (HFNO) in people with Obese, run by Assiut University.
Trial summary
Endoscopic retrograde cholangio-pancreatography (ERCP) is commonly performed under deep sedation to provide amnesia, comfort, and optimal procedural conditions. However, anesthetic drugs commonly used such as midazolam and/or propofol and opioids for sedative endoscopy in clinical practice may depress normal… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obese
- What is being tested?
- high flow nasal oxygen device (HFNO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2021to 31 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective ERCP with deep sedation will be enrolled
- age 18 - 70 years old
- obesity (BMI 30-35 kg/m2)
- American Society of Anaesthesiologists' physical status classification of 1 to 3
- Anticipated duration of the procedure is > 15 minutes.
Who cannot join
- • BMI >35 kg/m2
- Simple procedures of < 15 minutes duration.
- untreated or unstable cardiac conditions
- Nasal or oral disease resulting in difficulty of either nasal breathing or mouth breathing.
- Acute or chronic respiratory disorders as asthma and chronic obstructive pulmonary disease.
- Pregnant patients and patients having procedures with planned endotracheal intubation
- Expected difficult intubation patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: High Flow Nasal Oxygen Versus Nasal Continuous Positive Airway Pressure in Obese Patients Undergoing Deep Sedation for Endoscopic Retrograde Cholangiopancreatography: A Randomized Controlled Trial
Endoscopic retrograde cholangio-pancreatography (ERCP) is commonly performed under deep sedation to provide amnesia, comfort, and optimal procedural conditions. However, anesthetic drugs commonly used such as midazolam and/or propofol and opioids for sedative endoscopy in clinical practice may depress normal ventilation by blunting central chemoreceptor responsiveness to CO2, and alveolar hypoventilation and predispose patients to upper airway obstruction; all of that can result in hypoxemia, hypercarbia, respiratory acidosis, hypotension, and, in rare cases, brain injury or death.(1-3)
Read the detailed description
The incidence of hypoxia during ERCP with sedation has been reported to range from 16.2 to 39.2% (4) may be because ERCP procedures can be lengthy and are often performed in the prone position.(5) Hypoxemia is the most common adverse cardiopulmonary complication during sedated endoscopy and is caused by respiratory depression, airway obstruction, and decreased chest wall compliance. (2)
Obese patients are particularly at risk of upper airway obstruction and hypoxemia under sedation and may benefit from Conventional CPAP, applied nasally to improve ventilation and oxygenation during spontaneous ventilation in patients under deep sedation through maintenance of upper airway patency.(6) Recently novel techniques have been shown to be more effectively help ventilation than conventional low flow nasal oxygen. High flow nasal oxygen (HFNO) has been utilized in the intensive care setting for over 15 years. Its use in anaesthesia is rapidly increasing, providing an alternative to low flow oxygen devices during sedation for procedures such as gastroenterology, non-invasive cardiological, radiological, emergency medicine and persistent pain procedures.(1) Multiple mechanisms account for the therapeutic effects of HFNO, including a reduction in dead space, increased positive end-expiratory pressure, increased functional residual capacity, and delivery of higher inspired oxygen concentrations to the distal airways.(7) Moreover the heated and humidified HFNO provides adequate oxygenation with less drying of the upper airway mucosa, thereby improving patient comfort.(8) The use of HFNO in the gastroenterological suite had reduced critical incidents by providing high-inspired oxygen and slowing carbon dioxide rises related to respiratory depression.
Maintaining patient safety while successfully completing the procedures under sedation requires careful monitoring. Australian and New Zealand College of Anaesthetists (ANZCA) Guidelines on Monitoring during Anaesthesia, the Association of Anaesthetists of Great Britain \& Ireland (AAGBI) and the American Society of Anesthesiologists Standards for Basic Anesthetic Monitoring had all emphasized the importance of monitoring exhaled Co2 during moderate to deep sedation to improve patients' safety. (9) Monitoring EtCO2 for the anesthesiologist is more superior to the pulse oximeter for immediately detecting an obstructed airway, opiate-induced apnea, or other airway problems that only much later may be detected by the pulse oximeter.(9) Unfortunately, it would be expected that the high oxygen flow rates during HFNO would severely dilute expired carbon dioxide and make sampling impossible.
- Conditions
- Obese
- Being tested
- high flow nasal oxygen device (HFNO)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal oxygen device (HFNO)Device
it is a novel technique by which heated humidified oxygen is supplied via nasal prongs at flow rates ranging from 40 to 70 L/minute. The Fio2 ranges from 0.21 to 1.0.
| Study group | Role | What they receive |
|---|---|---|
| Group H | Active comparator | Oxygen will be delvered via HFNO canula at 20 L/min, Fio2 0.4 and temperature of 37o c using Vapotherm Precision Flow. Receives: Device: high flow nasal oxygen device (HFNO) |
| Group M | Active comparator | Mask group will be provided with nasal CPAP (10cmH2O) at an oxygen flow rate of 15 L/min. Receives: Device: high flow nasal oxygen device (HFNO) |
| Group C | Active comparator | In the Control group, oxygen via a nasal cannula at a flow rate of 5 L/min will be delivered Receives: Device: high flow nasal oxygen device (HFNO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A hypoxemia event
Spo2 <92% for at least 15 consecutive seconds (we based our definition on prior studies)
Measured: for 15 consecutive secondes
Secondary outcomes (2)
The lowest Spo2 reading
the lowest spo2
Measured: during the whole procedure
Incidence of hypercapnia
PaCo2 will be assessed in an venous blood gas sample drawn before induction of anaesthesia and second sample 5 min. after induction and then every 10 min till the end of the procedure
Measured: before induction, 5 min after induction and then every 10 min till end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start30 Oct 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Allah Mahmoud Bakri, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912102
- Sponsor's protocol ID
- HFNO Vs CPAP in ERCP
- Status last verified
- May 2021
- First submitted
- 28 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bhananker SM, Posner KL, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: a closed claims analysis. Anesthesiology. 2006 Feb;104(2):228-34. doi: 10.1097/00000542-200602000-00005.
PubMed 16436839Amornyotin S. Sedation-related complications in gastrointestinal endoscopy. World J Gastrointest Endosc. 2013 Nov 16;5(11):527-33. doi: 10.4253/wjge.v5.i11.527.
PubMed 24255744Mazzeffi MA, Petrick KM, Magder L, Greenwald BD, Darwin P, Goldberg EM, Bigeleisen P, Chow JH, Anders M, Boyd CM, Kaplowitz JS, Sun K, Terrin M, Rock P. High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial. Anesth Analg. 2021 Mar 1;132(3):743-751. doi: 10.1213/ANE.0000000000004837.
PubMed 32398433Wang CY, Ling LC, Cardosa MS, Wong AK, Wong NW. Hypoxia during upper gastrointestinal endoscopy with and without sedation and the effect of pre-oxygenation on oxygen saturation. Anaesthesia. 2000 Jul;55(7):654-8. doi: 10.1046/j.1365-2044.2000.01520.x.
PubMed 10919420Muller S, Prolla JC, Maguilnik I, Breyer HP. Predictive factors of oxygen desaturation of patients submitted to endoscopic retrograde cholangiopancreatography under conscious sedation. Arq Gastroenterol. 2004 Jul-Sep;41(3):162-6. doi: 10.1590/s0004-28032004000300005. Epub 2005 Jan 21.
PubMed 15678200Andrade RG, Piccin VS, Nascimento JA, Viana FM, Genta PR, Lorenzi-Filho G. Impact of the type of mask on the effectiveness of and adherence to continuous positive airway pressure treatment for obstructive sleep apnea. J Bras Pneumol. 2014 Nov-Dec;40(6):658-68. doi: 10.1590/S1806-37132014000600010.
PubMed 25610507Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
PubMed 25866645Greenland KB. A potential method for obtaining wave-form capnography during high flow nasal oxygen. Anaesth Intensive Care. 2019 Mar;47(2):204-206. doi: 10.1177/0310057X19836430. Epub 2019 May 1. No abstract available.
PubMed 31042046Weaver J. The latest ASA mandate: CO(2) monitoring for moderate and deep sedation. Anesth Prog. 2011 Fall;58(3):111-2. doi: 10.2344/0003-3006-58.3.111. No abstract available.
PubMed 21882985
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygen Versus Nasal Continuous Positive Airway Pressure in Obese Patients Undergoing Deep Sedation for Endoscopic Retrograde Cholangiopancreatography: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04912102
- Acronym / sponsor ID
- HFNO Vs CPAP in ERCP
- Conditions
- Obese
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jun 2021 (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 cholangio-pancreatography (ERCP) is commonly performed under deep sedation to provide amnesia, comfort, and optimal procedural conditions. However, anesthetic drugs commonly used such as midazolam and/or propofol and opioids for sedative endoscopy in clinical practice may depress normal ventilation by blunting central chemoreceptor responsiveness to CO2, and alveolar hypoventilation and predispose patients to upper airway obstruction; all of that can result in hypoxemia, hypercarbia, respiratory acidosis, hypotension, and, in rare cases, brain injury or death.(1-3)
Detailed description
The incidence of hypoxia during ERCP with sedation has been reported to range from 16.2 to 39.2% (4) may be because ERCP procedures can be lengthy and are often performed in the prone position.(5) Hypoxemia is the most common adverse cardiopulmonary complication during sedated endoscopy and is caused by respiratory depression, airway obstruction, and decreased chest wall compliance. (2)
Obese patients are particularly at risk of upper airway obstruction and hypoxemia under sedation and may benefit from Conventional CPAP, applied nasally to improve ventilation and oxygenation during spontaneous ventilation in patients under deep sedation through maintenance of upper airway patency.(6) Recently novel techniques have been shown to be more effectively help ventilation than conventional low flow nasal oxygen. High flow nasal oxygen (HFNO) has been utilized in the intensive care setting for over 15 years. Its use in anaesthesia is rapidly increasing, providing an alternative to low flow oxygen devices during sedation for procedures such as gastroenterology, non-invasive cardiological, radiological, emergency medicine and persistent pain procedures.(1) Multiple mechanisms account for the therapeutic effects of HFNO, including a reduction in dead space, increased positive end-expiratory pressure, increased functional residual capacity, and delivery of higher inspired oxygen concentrations to the distal airways.(7) Moreover the heated and humidified HFNO provides adequate oxygenation with less drying of the upper airway mucosa, thereby improving patient comfort.(8) The use of HFNO in the gastroenterological suite had reduced critical incidents by providing high-inspired oxygen and slowing carbon dioxide rises related to respiratory depression.
Maintaining patient safety while successfully completing the procedures under sedation requires careful monitoring. Australian and New Zealand College of Anaesthetists (ANZCA) Guidelines on Monitoring during Anaesthesia, the Association of Anaesthetists of Great Britain \& Ireland (AAGBI) and the American Society of Anesthesiologists Standards for Basic Anesthetic Monitoring had all emphasized the importance of monitoring exhaled Co2 during moderate to deep sedation to improve patients' safety. (9) Monitoring EtCO2 for the anesthesiologist is more superior to the pulse oximeter for immediately detecting an obstructed airway, opiate-induced apnea, or other airway problems that only much later may be detected by the pulse oximeter.(9) Unfortunately, it would be expected that the high oxygen flow rates during HFNO would severely dilute expired carbon dioxide and make sampling impossible.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group H | Active comparator | Device: high flow nasal oxygen device (HFNO)Oxygen will be delvered via HFNO canula at 20 L/min, Fio2 0.4 and temperature of 37o c using Vapotherm Precision Flow. |
| Group M | Active comparator | Device: high flow nasal oxygen device (HFNO)Mask group will be provided with nasal CPAP (10cmH2O) at an oxygen flow rate of 15 L/min. |
| Group C | Active comparator | Device: high flow nasal oxygen device (HFNO)In the Control group, oxygen via a nasal cannula at a flow rate of 5 L/min will be delivered |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients undergoing elective ERCP with deep sedation will be enrolled
- age 18 - 70 years old
- obesity (BMI 30-35 kg/m2)
- American Society of Anaesthesiologists' physical status classification of 1 to 3
- Anticipated duration of the procedure is > 15 minutes.
Key exclusion criteria (7 listed)
- • BMI >35 kg/m2
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 oxygen device (HFNO)it is a novel technique by which heated humidified oxygen is supplied via nasal prongs at flow rates ranging from 40 to 70 L/minute. The Fio2 ranges from 0.21 to 1.0. | Device | Group C, Group H, Group M |
Primary outcome
A hypoxemia event
Time frame: for 15 consecutive secondes
Spo2 <92% for at least 15 consecutive seconds (we based our definition on prior studies)
2 secondary outcomes
The lowest Spo2 reading
Time frame: during the whole procedure
Incidence of hypercapnia
Time frame: before induction, 5 min after induction and then every 10 min till end of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Background: PubMed 16436839Bhananker SM, Posner KL, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: a closed claims analysis. Anesthesiology. 2006 Feb;104(2):228-34. doi: 10.1097/00000542-200602000-00005.
- Background: PubMed 24255744Amornyotin S. Sedation-related complications in gastrointestinal endoscopy. World J Gastrointest Endosc. 2013 Nov 16;5(11):527-33. doi: 10.4253/wjge.v5.i11.527.
- Background: PubMed 32398433Mazzeffi MA, Petrick KM, Magder L, Greenwald BD, Darwin P, Goldberg EM, Bigeleisen P, Chow JH, Anders M, Boyd CM, Kaplowitz JS, Sun K, Terrin M, Rock P. High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial. Anesth Analg. 2021 Mar 1;132(3):743-751. doi: 10.1213/ANE.0000000000004837.
- Background: PubMed 10919420Wang CY, Ling LC, Cardosa MS, Wong AK, Wong NW. Hypoxia during upper gastrointestinal endoscopy with and without sedation and the effect of pre-oxygenation on oxygen saturation. Anaesthesia. 2000 Jul;55(7):654-8. doi: 10.1046/j.1365-2044.2000.01520.x.
- Background: PubMed 15678200Muller S, Prolla JC, Maguilnik I, Breyer HP. Predictive factors of oxygen desaturation of patients submitted to endoscopic retrograde cholangiopancreatography under conscious sedation. Arq Gastroenterol. 2004 Jul-Sep;41(3):162-6. doi: 10.1590/s0004-28032004000300005. Epub 2005 Jan 21.
- Background: PubMed 25610507Andrade RG, Piccin VS, Nascimento JA, Viana FM, Genta PR, Lorenzi-Filho G. Impact of the type of mask on the effectiveness of and adherence to continuous positive airway pressure treatment for obstructive sleep apnea. J Bras Pneumol. 2014 Nov-Dec;40(6):658-68. doi: 10.1590/S1806-37132014000600010.
- Background: PubMed 25866645Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
- Background: PubMed 31042046Greenland KB. A potential method for obtaining wave-form capnography during high flow nasal oxygen. Anaesth Intensive Care. 2019 Mar;47(2):204-206. doi: 10.1177/0310057X19836430. Epub 2019 May 1. No abstract available.
- Background: PubMed 21882985Weaver J. The latest ASA mandate: CO(2) monitoring for moderate and deep sedation. Anesth Prog. 2011 Fall;58(3):111-2. doi: 10.2344/0003-3006-58.3.111. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal oxygen device (HFNO) in people with Obese, run by Assiut University.
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 7 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 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Menna M Bakri, assisstant lecturer (01090692006, mennatallah1990@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A hypoxemia event (time frame: for 15 consecutive secondes). 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 NCT04912102, which also lists 9 linked publications.
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 3 Jun 2021.