HFNO Versus Nasal CPAP in Obese Patients Undergoing Deep Sedation for ERCP
Primary Purpose
Obese
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high flow nasal oxygen device (HFNO)
Sponsored by

About this trial
This is an interventional prevention trial for Obese
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
• 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group H
Group M
Group C
Arm Description
Oxygen will be delvered via HFNO canula at 20 L/min, Fio2 0.4 and temperature of 37o c using Vapotherm Precision Flow.
Mask group will be provided with nasal CPAP (10cmH2O) at an oxygen flow rate of 15 L/min.
In the Control group, oxygen via a nasal cannula at a flow rate of 5 L/min will be delivered
Outcomes
Primary Outcome Measures
A hypoxemia event
Spo2 <92% for at least 15 consecutive seconds (we based our definition on prior studies)
Secondary Outcome Measures
The lowest Spo2 reading
the lowest spo2
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04912102
Brief Title
HFNO Versus Nasal CPAP in Obese Patients Undergoing Deep Sedation for ERCP
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2021 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group H
Arm Type
Active Comparator
Arm Description
Oxygen will be delvered via HFNO canula at 20 L/min, Fio2 0.4 and temperature of 37o c using Vapotherm Precision Flow.
Arm Title
Group M
Arm Type
Active Comparator
Arm Description
Mask group will be provided with nasal CPAP (10cmH2O) at an oxygen flow rate of 15 L/min.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
In the Control group, oxygen via a nasal cannula at a flow rate of 5 L/min will be delivered
Intervention Type
Device
Intervention Name(s)
high flow nasal oxygen device (HFNO)
Intervention Description
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.
Primary Outcome Measure Information:
Title
A hypoxemia event
Description
Spo2 <92% for at least 15 consecutive seconds (we based our definition on prior studies)
Time Frame
for 15 consecutive secondes
Secondary Outcome Measure Information:
Title
The lowest Spo2 reading
Description
the lowest spo2
Time Frame
during the whole procedure
Title
Incidence of hypercapnia
Description
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
Time Frame
before induction, 5 min after induction and then every 10 min till end of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
• 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Menna M Bakri, assisstant lecturer
Phone
01090692006
Email
mennatallah1990@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Shimaa A Hassan, lecturer
Phone
01002953253
Email
shimaa.abbas@med.aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16436839
Citation
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.
Results Reference
background
PubMed Identifier
24255744
Citation
Amornyotin 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.
Results Reference
background
PubMed Identifier
32398433
Citation
Mazzeffi 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.
Results Reference
background
PubMed Identifier
10919420
Citation
Wang 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.
Results Reference
background
PubMed Identifier
15678200
Citation
Muller 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.
Results Reference
background
PubMed Identifier
25610507
Citation
Andrade 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.
Results Reference
background
PubMed Identifier
25866645
Citation
Nishimura 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.
Results Reference
background
PubMed Identifier
31042046
Citation
Greenland 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.
Results Reference
background
PubMed Identifier
21882985
Citation
Weaver 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.
Results Reference
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HFNO Versus Nasal CPAP in Obese Patients Undergoing Deep Sedation for ERCP
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