search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obese

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 28, 2021
    Last Updated
    June 2, 2021
    Sponsor
    Assiut University
    search

    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
    background

    Learn more about this trial

    HFNO Versus Nasal CPAP in Obese Patients Undergoing Deep Sedation for ERCP

    We'll reach out to this number within 24 hrs