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High Flow Nasal Cannula in Immunocompromised Patient With Acute Respiratory Failure

Primary Purpose

High Flow Nasal Cannula, Non Invasive Ventilation, Acute Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Flow Nasal Cannula
Non Invasive Ventilation
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High Flow Nasal Cannula focused on measuring High flow nasal cannula, ., Non invasive ventilation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • . Inclusion criteria includes admitted immunocompromised patient to ICU with acute hypoxemic respiratory failure (ARF).
  • Hematological malignancies.
  • Post bone marrow transplantation

Exclusion Criteria:

  • Need of emergency intubation.
  • patient with deterioration of conscious level with hypoxemia with FiO2 less than 90% in spite of maximum O2 support.

    • hemodynamic instability with need of vasoconstrictor support.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    High flow nasal cannula (HFNC) group

    Non invasive ventilation (NIV) group

    Arm Description

    HFNC group will receive immediate connection to HFNC with a flow of 60L/min, and FIO2 adjusted to have SpO2 of 92% or more, through a heated humidifier and a oxygen blender of the same machine. In case of patient intolerance to high flow, flow will be diminished to the highest tolerated by the patient. Patients will be encouraged to have their mouth closed during HFNC to augment positive end expiratory pressure (PEEP) created by high flow.

    NIV group, patients will be connected to ICU ventilatoron NIV mode for at least 4 hours, through a NIV continuous positive airway pressure (CPAP)mask with ventilator settings; pressure support (PS) level of 8 cmH2O and PEEP level of 5 cmH2O,which can be increased to 10 cmH2O to maintain tidal volume between 6-8 ml/Kg and FiO2 adjusted to keep SpO2 equal or more than 92%.At least patient will be on NIV for 12 hours during the day, alternating with Venturi mask 10-15 L/min to keep FiO2 equal or more than 92%.

    Outcomes

    Primary Outcome Measures

    primary outcome will be need for endotracheal intubation within 48 hours of admission
    Need for endotracheal intubation within 48 hours of admission to ICU

    Secondary Outcome Measures

    secondary outcome will be mortality rate after 28 days of admission.
    mortality rate after 28 days after patient admission to ICU.

    Full Information

    First Posted
    February 22, 2020
    Last Updated
    February 28, 2020
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04293991
    Brief Title
    High Flow Nasal Cannula in Immunocompromised Patient With Acute Respiratory Failure
    Official Title
    High Flow Nasal Cannula Versus Non Invasive Ventilation in Prevention of Intubbation in Immunocompromised Patient With Acute Hypoxxemic Respiratory Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2020 (Anticipated)
    Primary Completion Date
    July 2020 (Anticipated)
    Study Completion Date
    August 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    This study will be conducted in Ain Shams University Hospital in the general intensive care unit after ethical committee approval number (FMASU R 9/2020) .It is a prospective randomized controlled study. Eligible patients will be randomized by computer system to one of two groups either High Flow Nasal Oxygen (HFNO) group or Non Invasive Ventilation (NIV) group. Inclusion criteria includes admitted immunocompromised patients to our general 34 beds ICU with acute hypoxemic respiratory failure (ARF).
    Detailed Description
    ARF is characterized by respiratory rate more than 25/min, PaO2/FiO2 less than 300 under standard O2 10 L/min, or findings of persistent pulmonary infiltrates in radiographs. Immunocompromised patients have one or more of the following criteria hematological malignancy (either active or remitting in the last 5 years), bone marrow transplantation (in the last 5 years), severe leucopenia less than 1000 white blood cells in cubic millimeter, solid organ transplantation, steroid therapy more than 0.5 mg/kg/day for at least 3 weeks, or cytotoxic therapy for non malignant disease. Patients included in the study will be randomized after admission to ICU to one of two groups, HFNC group or NIV group. Patients enrolled in HFNC group will receive immediate connection to HFNC with a flow of 60L/min, and FIO2 adjusted to have SpO2 of 92% or more, through a heated humidifier and a oxygen blender of the same machine. In case of patient intolerance to high flow, flow will be diminished to the highest tolerated by the patient. Patients will be encouraged to have their mouth closed during HFNC to augment positive end expiratory pressure (PEEP) created by high flow.NIV group, patients will be connected to ICU ventilator on NIV mode for at least 4 hours, through a NIV continuous positive airway pressure (CPAP)mask with ventilator settings; pressure support (PS) level of 8 cmH2O and PEEP level of 5 cmH2O,which can be increased to 10 cmH2O

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Flow Nasal Cannula, Non Invasive Ventilation, Acute Respiratory Failure
    Keywords
    High flow nasal cannula, ., Non invasive ventilation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High flow nasal cannula (HFNC) group
    Arm Type
    Active Comparator
    Arm Description
    HFNC group will receive immediate connection to HFNC with a flow of 60L/min, and FIO2 adjusted to have SpO2 of 92% or more, through a heated humidifier and a oxygen blender of the same machine. In case of patient intolerance to high flow, flow will be diminished to the highest tolerated by the patient. Patients will be encouraged to have their mouth closed during HFNC to augment positive end expiratory pressure (PEEP) created by high flow.
    Arm Title
    Non invasive ventilation (NIV) group
    Arm Type
    Active Comparator
    Arm Description
    NIV group, patients will be connected to ICU ventilatoron NIV mode for at least 4 hours, through a NIV continuous positive airway pressure (CPAP)mask with ventilator settings; pressure support (PS) level of 8 cmH2O and PEEP level of 5 cmH2O,which can be increased to 10 cmH2O to maintain tidal volume between 6-8 ml/Kg and FiO2 adjusted to keep SpO2 equal or more than 92%.At least patient will be on NIV for 12 hours during the day, alternating with Venturi mask 10-15 L/min to keep FiO2 equal or more than 92%.
    Intervention Type
    Device
    Intervention Name(s)
    High Flow Nasal Cannula
    Intervention Description
    Evaluate the use of HFNC in prevention of intubation in immunocompromised patients adimitted to icu.
    Intervention Type
    Device
    Intervention Name(s)
    Non Invasive Ventilation
    Intervention Description
    Evaluate the use of HFNC in prevention of intubation in immunocompromised patient admitted to icu.
    Primary Outcome Measure Information:
    Title
    primary outcome will be need for endotracheal intubation within 48 hours of admission
    Description
    Need for endotracheal intubation within 48 hours of admission to ICU
    Time Frame
    48 hours of patient admission to ICU.
    Secondary Outcome Measure Information:
    Title
    secondary outcome will be mortality rate after 28 days of admission.
    Description
    mortality rate after 28 days after patient admission to ICU.
    Time Frame
    28 days after patient admission to ICU.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: . Inclusion criteria includes admitted immunocompromised patient to ICU with acute hypoxemic respiratory failure (ARF). Hematological malignancies. Post bone marrow transplantation Exclusion Criteria: Need of emergency intubation. patient with deterioration of conscious level with hypoxemia with FiO2 less than 90% in spite of maximum O2 support. hemodynamic instability with need of vasoconstrictor support.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashraf Elagamy, MD
    Phone
    002022470193
    Email
    elagamy_ashraf@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dalia Elfawy
    Email
    daliamfawy@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sameh Salem, MD
    Organizational Affiliation
    Professor Doctor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Not yet decided that patient participating will accept for share their information or no.

    Learn more about this trial

    High Flow Nasal Cannula in Immunocompromised Patient With Acute Respiratory Failure

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