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HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

Primary Purpose

Comparison Between HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HVNI
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Comparison Between HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Participants admitted to the RICU with acute hypercapnic respiratory failure requiring NIV support with the following criteria:

  1. RR> 25 breath/minute.
  2. Use of accessory muscles of respiration, paradoxical breathing, thoracoabdominal asynchrony.
  3. Hypoxemia evidenced by the following items:

    • In patient with hypercapnic ARF:

I.Need for oxygen therapy at FIO2> 40% to maintain PaO2 > 60 mmHg or SaO2> 90% II.Blood gas analysis shows pH <7.35 and paCO2> 45 mmHg

-

Exclusion Criteria:Patients with ARF who have any of the following:

I.Indication for emergency endotracheal intubation. II.HR < 50 beat\minute with decreased level of consciousness III.Persistent hemodynamic instability with

  • Systolic blood pressure <90 mmHg after infusing a bolus of crystalloid solution at a dose of 30 ml / kg.
  • life-threatening arrhythmia. IV.Undrained pneumothorax or Pneumothorax with persistent air leak. V.Extensive facial trauma or burnVI.Refusal to participate. VII.Usual long-term treatment with NIV for chronic disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    HVNI

    Noninvasive ventilation

    Arm Description

    High velocity nasal insufflation (Fisher &Paykel, Auckland, New Zealan High-velocity nasal insufflation (Precision Flow;Vapotherm, Inc, Exeter, NH) (Figure 2) using a smallborenasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort

    Respiratory assistance is provided by a NIV either Puritan Bennet 840 (Covidien, U.S.A.), EngströmCarestation (GE Healthcare, Finland) or Hamilton-G5 (Hamilton Medical, Germany), will be used for conventional non-invasive ventilation via an oronasal mask that helps patients to cope with their Breathlessness. Settings will be adjusted based on the clinical assessment of the respiratory therapist as per standard practice.

    Outcomes

    Primary Outcome Measures

    Endotracheal intubation rate
    Endotracheal intubation rate

    Secondary Outcome Measures

    Full Information

    First Posted
    August 2, 2021
    Last Updated
    August 2, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04998383
    Brief Title
    HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
    Official Title
    HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2021 (Anticipated)
    Primary Completion Date
    August 2022 (Anticipated)
    Study Completion Date
    August 2022 (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
    To study the efficacy and safety of high flow nasal oxygenation using high velocity nasal insfflation technique(HiVNI) in comarison with non invasive positive pressure ventilation in COPD patients with acute hyercapnic respiratory failure To do selection criteria for the indication of this new physiological technique in critically ill COPD patients
    Detailed Description
    Dyspnea and acute respiratory failure are among the top 5 reasons for patients to present to the emergency department (ED)(1).Supplemental oxygen therapy forms the cornerstone of resuscitation of the acutely unwell patient.Under normal circumstances, tissue hypoxia occurs within 4 min of inadequate tissue oxygenation (2). Oxygen delivery to the peripheral tissues depends upon the product of cardiac output and the arterial oxygen content (3), which is partly dependent on FIO2. In intensive care unit (ICU) patients with acute respiratory failure, non-invasive strategies of oxygenation are mainly used to avoid invasive mechanical ventilation (4). In such situations, the goal of treatment should not only be survival, but also improved respiratory condition and avoidance of inappropriate discomforts. Since the 90's, noninvasive ventilation (NIV) has been largely used with strong level of evidence in cardiogenic pulmonary edema and chronic obstructive pulmonary disease (COPD) exacerbation. NIV improves gas exchange and reduces inspiratory effort through positive pressure. However, good tolerance to NIV is sometimes difficult to achieve due to frequent leaks around the mask, possibly leading to patientventilator asynchrony and even to intubation. It may have other deleterious effects such as delayed intubation by masking signs of respiratory distress, or barotrauma by the high tidal volume potentially generated under positive pressure (5). High-velocity nasal insufflation (Hi-VNI), a viable alternative to NiPPV in treating adults in undifferentiated respiratory distress. It provides both oxygenation and ventilatory support to reduce hypercapnia(6).It focuses on optimum efficiency of the deadspace purge to augment ventilation (7,8), in addition to delivering up to 100% oxygen by nasal cannula(9,10) This is accomplished by use of small-bore nasal cannulae (typically 2.7-mm internal diameter for adult patients) to produce high velocity flow that is approximately 360% greater than that of the larger bore cannulae. It requires a flow of 25 to 35 L/min in adults to accomplish a complete purge of the extrathoracic anatomic reservoir between breaths (8,11).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Comparison Between HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be randomized to either high-velocity nasal insufflation or noninvasive positive-pressure ventilation therapy and they will be enrolled if they met the inclusion criteria.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HVNI
    Arm Type
    Experimental
    Arm Description
    High velocity nasal insufflation (Fisher &Paykel, Auckland, New Zealan High-velocity nasal insufflation (Precision Flow;Vapotherm, Inc, Exeter, NH) (Figure 2) using a smallborenasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort
    Arm Title
    Noninvasive ventilation
    Arm Type
    Experimental
    Arm Description
    Respiratory assistance is provided by a NIV either Puritan Bennet 840 (Covidien, U.S.A.), EngströmCarestation (GE Healthcare, Finland) or Hamilton-G5 (Hamilton Medical, Germany), will be used for conventional non-invasive ventilation via an oronasal mask that helps patients to cope with their Breathlessness. Settings will be adjusted based on the clinical assessment of the respiratory therapist as per standard practice.
    Intervention Type
    Device
    Intervention Name(s)
    HVNI
    Intervention Description
    High velocity nasal insufflation (Fisher &Paykel, Auckland, New Zealan High-velocity nasal insufflation (Precision Flow;Vapotherm, Inc, Exeter, NH) (Figure 2) using a smallborenasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort.
    Primary Outcome Measure Information:
    Title
    Endotracheal intubation rate
    Description
    Endotracheal intubation rate
    Time Frame
    after 2 Hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria:Participants admitted to the RICU with acute hypercapnic respiratory failure requiring NIV support with the following criteria: RR> 25 breath/minute. Use of accessory muscles of respiration, paradoxical breathing, thoracoabdominal asynchrony. Hypoxemia evidenced by the following items: In patient with hypercapnic ARF: I.Need for oxygen therapy at FIO2> 40% to maintain PaO2 > 60 mmHg or SaO2> 90% II.Blood gas analysis shows pH <7.35 and paCO2> 45 mmHg - Exclusion Criteria:Patients with ARF who have any of the following: I.Indication for emergency endotracheal intubation. II.HR < 50 beat\minute with decreased level of consciousness III.Persistent hemodynamic instability with Systolic blood pressure <90 mmHg after infusing a bolus of crystalloid solution at a dose of 30 ml / kg. life-threatening arrhythmia. IV.Undrained pneumothorax or Pneumothorax with persistent air leak. V.Extensive facial trauma or burnVI.Refusal to participate. VII.Usual long-term treatment with NIV for chronic disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nagah Gaber, MD
    Phone
    01009714349
    Email
    nagahgaber89@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed hamed, prof.dr
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Khalid Hussein, prof.dr
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Samiaa Hamdy, assistant professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
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    25144109
    Citation
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    Results Reference
    result
    PubMed Identifier
    9740573
    Citation
    Bateman NT, Leach RM. ABC of oxygen. Acute oxygen therapy. BMJ. 1998 Sep 19;317(7161):798-801. doi: 10.1136/bmj.317.7161.798. No abstract available.
    Results Reference
    result
    PubMed Identifier
    28860265
    Citation
    Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
    Results Reference
    result
    PubMed Identifier
    28828372
    Citation
    Frat JP, Coudroy R, Marjanovic N, Thille AW. High-flow nasal oxygen therapy and noninvasive ventilation in the management of acute hypoxemic respiratory failure. Ann Transl Med. 2017 Jul;5(14):297. doi: 10.21037/atm.2017.06.52.
    Results Reference
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    PubMed Identifier
    29310868
    Citation
    Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.
    Results Reference
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    PubMed Identifier
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    Citation
    Frizzola M, Miller TL, Rodriguez ME, Zhu Y, Rojas J, Hesek A, Stump A, Shaffer TH, Dysart K. High-flow nasal cannula: impact on oxygenation and ventilation in an acute lung injury model. Pediatr Pulmonol. 2011 Jan;46(1):67-74. doi: 10.1002/ppul.21326. Epub 2010 Nov 23.
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    Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21.
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    PubMed Identifier
    25742321
    Citation
    Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.
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    Citation
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    HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

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