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High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing The Rate of Reintubation

Primary Purpose

Respiratory Failure, Re-intubation Rate

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high flow nasal cannula
non invasive positive pressure ventilation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All patient suffer from acute respiratory failure and intubated for mechanical ventilation and then extubated for weaning Age >18 years old Exclusion Criteria: In patients less than 18 years old Any contradiction in using HFNC as trauma or surgery or obstruction of nasopharynx Any contradiction in using NIPPV as facial trauma ..surgery ..deformity..or upper airway obstruction or upper gastrointestinal bleeding or high risk of aspiration

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    high flow nasal cannula group

    non invasive positive pressure ventilation group

    Arm Description

    patients put on high flow nasal cannula after extubation

    patients put on non invasive positive pressure ventilation group after extubation

    Outcomes

    Primary Outcome Measures

    the need for re-intubation and weaning success which will be measured by arterial blood gas ( ABG )

    Secondary Outcome Measures

    Duration of using of HFNC or NIPPV
    Length of hospital stay measured by days
    In - hospital mortality measured by number of died cases
    Adverse events
    Adverse events (occurrence of nosocomial pneumonia based on clinical and laboratory and radiological finding, need for MV measured by re-intubation rate)
    Incidence of any possible complications associated with the use of HFNC and NIPPV

    Full Information

    First Posted
    August 25, 2023
    Last Updated
    September 7, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06029699
    Brief Title
    High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing The Rate of Reintubation
    Official Title
    High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing Reintubation in Mechanically Ventilated Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2026 (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
    This is study aim to compare between high flow nasal canula (HFNC) and non invasive positive pressure ventilation (NIPPV) in reducing the rate of reintubation in mechanically ventilated patient with successful weaning
    Detailed Description
    High-flow nasal cannula (HFNC) oxygen therapy comprises an air/oxygen blender, an active humidifier, a single heated circuit, and a nasal cannula. It delivers adequately heated and humidified medical gas at up to 60 L/min of flow and is considered to have a number of physiological effects: reduction of anatomical dead space, positive end expiratory pressure ( PEEP ) effect, constant fraction of inspired oxygen, and good humidification Noninvasive positive-pressure ventilation is a safe and effective means of improving gas exchange in patients with many types of acute respiratory failure . for example, adding noninvasive ventilation to standard therapy decreased the need for endotracheal intubation...For patients assigned to noninvasive ventilation, the ventilator was connected with conventional tubing to a clear, full-face mask with an inflatable soft-cushion seal and a disposable foam spacer to reduce dead space .After the mask had been secured, pressure support was increased to achieve an exhaled tidal volume of 8 to 10 ml per kilogram, a respiratory rate of fewer than 25 breaths per minute, the disappearance of accessory muscle activity (as evaluated by palpation of the sternocleidomastoid muscle), and patient comfort The effects of high-flow nasal cannula (HFNC) on adult patients with acute respiratory failure (ARF) are controversial. The investigators aimed to further determine the effectiveness of HFNC in reducing the rate of endotracheal intubation in adult patients with ARF by comparison to noninvasive positive pressure ventilation (NIPPV)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Failure, Re-intubation Rate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    When the patient become weanable from mechanical ventilation, the subjects were extubated immediately and randomly divided into two groups, with one group receiving HFNC (called HFNC group), the other group receiving NIPPV (called NIPPV group)
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    high flow nasal cannula group
    Arm Type
    Active Comparator
    Arm Description
    patients put on high flow nasal cannula after extubation
    Arm Title
    non invasive positive pressure ventilation group
    Arm Type
    Active Comparator
    Arm Description
    patients put on non invasive positive pressure ventilation group after extubation
    Intervention Type
    Device
    Intervention Name(s)
    high flow nasal cannula
    Intervention Description
    device are used for weaning patients after mechanical ventilation extubation
    Intervention Type
    Device
    Intervention Name(s)
    non invasive positive pressure ventilation
    Intervention Description
    device are used for weaning patients after mechanical ventilation extubation
    Primary Outcome Measure Information:
    Title
    the need for re-intubation and weaning success which will be measured by arterial blood gas ( ABG )
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Duration of using of HFNC or NIPPV
    Time Frame
    up to 30 days
    Title
    Length of hospital stay measured by days
    Time Frame
    up to 30 days
    Title
    In - hospital mortality measured by number of died cases
    Time Frame
    up to 30 days
    Title
    Adverse events
    Description
    Adverse events (occurrence of nosocomial pneumonia based on clinical and laboratory and radiological finding, need for MV measured by re-intubation rate)
    Time Frame
    up to 30 days
    Title
    Incidence of any possible complications associated with the use of HFNC and NIPPV
    Time Frame
    up to 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All patient suffer from acute respiratory failure and intubated for mechanical ventilation and then extubated for weaning Age >18 years old Exclusion Criteria: In patients less than 18 years old Any contradiction in using HFNC as trauma or surgery or obstruction of nasopharynx Any contradiction in using NIPPV as facial trauma ..surgery ..deformity..or upper airway obstruction or upper gastrointestinal bleeding or high risk of aspiration
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohamed osman shehata abdelkareem, resident doctor
    Phone
    +201123368743
    Email
    abkmod@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maha Kamel Ghanem, professor
    Phone
    +201227694434
    Email
    mahaghanem@hotmail.com

    12. IPD Sharing Statement

    Citations:
    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
    8147550
    Citation
    Meyer TJ, Hill NS. Noninvasive positive pressure ventilation to treat respiratory failure. Ann Intern Med. 1994 May 1;120(9):760-70. doi: 10.7326/0003-4819-120-9-199405010-00008.
    Results Reference
    background
    PubMed Identifier
    28089816
    Citation
    Ni YN, Luo J, Yu H, Liu D, Ni Z, Cheng J, Liang BM, Liang ZA. Can High-flow Nasal Cannula Reduce the Rate of Endotracheal Intubation in Adult Patients With Acute Respiratory Failure Compared With Conventional Oxygen Therapy and Noninvasive Positive Pressure Ventilation?: A Systematic Review and Meta-analysis. Chest. 2017 Apr;151(4):764-775. doi: 10.1016/j.chest.2017.01.004. Epub 2017 Jan 13.
    Results Reference
    background
    PubMed Identifier
    34955131
    Citation
    Fang G, Wan Q, Tian Y, Jia W, Luo X, Yang T, Shi Y, Gu X, Xu S. [Comparative study on pros and cons of sequential high-flow nasal cannula and non-invasive positive pressure ventilation immediately following early extubated patients with severe respiratory failure due to acute exacerbations of chronic obstructive pulmonary disease]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2021 Oct;33(10):1215-1220. doi: 10.3760/cma.j.cn121430-20210623-00939. Chinese.
    Results Reference
    background
    PubMed Identifier
    12172066
    Citation
    Gomez-Merino E, Sancho J, Marin J, Servera E, Blasco ML, Belda FJ, Castro C, Bach JR. Mechanical insufflation-exsufflation: pressure, volume, and flow relationships and the adequacy of the manufacturer's guidelines. Am J Phys Med Rehabil. 2002 Aug;81(8):579-83. doi: 10.1097/00002060-200208000-00004.
    Results Reference
    background

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    High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing The Rate of Reintubation

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