High Flow Nasal Cannula in Immunocompromised Patient With Acute Respiratory Failure

High Flow Nasal Cannula Versus Non Invasive Ventilation in Prevention of Intubbation in Immunocompromised Patient With Acute Hypoxxemic Respiratory Failure

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).

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Failure; High Flow Nasal Cannula; Non Invasive Ventilation
• Intervention / Treatment: Device: High Flow Nasal Cannula; Device: Non Invasive Ventilation

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

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashraf Elagamy, MD; Phone Number: 002022470193; Email: elagamy_ashraf@yahoo.com
• Study Contact Backup: Name: Dalia Elfawy; Email: daliamfawy@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High flow nasal cannula (HFNC) group; 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.	Device: High Flow Nasal Cannula; Evaluate the use of HFNC in prevention of intubation in immunocompromised patients adimitted to icu.
Active Comparator: Non invasive ventilation (NIV) group; 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%.	Device: Non Invasive Ventilation; Evaluate the use of HFNC in prevention of intubation in immunocompromised patient admitted to icu.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary outcome will be need for endotracheal intubation within 48 hours of admission	Need for endotracheal intubation within 48 hours of admission to ICU	48 hours of patient admission to ICU.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary outcome will be mortality rate after 28 days of admission.	mortality rate after 28 days after patient admission to ICU.	28 days after patient admission to ICU.

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Sameh Salem, MD, Professor doctor

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: February 22, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Non invasive ventilation; High flow nasal cannula, .
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: FMASU R 9 / 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not yet decided that patient participating will accept for share their information or no.

Drug and device information, study documents

• 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