High Flow Nasal Cannula in Immunocompromised Patient With Acute Respiratory Failure

Not Applicable

• Conditions: Non Invasive Ventilation; High Flow Nasal Cannula; Acute Respiratory Failure
• Interventions: Device: Non Invasive Ventilation; Device: High Flow Nasal Cannula

• Registration Number: NCT04293991
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-22
• Study First Submitted QC: 2020-02-28
• Last Update Submitted: 2020-02-28
• Study Start: 2020-03
• Study First Posted: 2020-03-03
• Last Update Posted: 2020-03-03
• Primary Completion: 2020-07
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non invasive ventilation (NIV) group	Non Invasive Ventilation	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%.
High flow nasal cannula (HFNC) group	High Flow Nasal Cannula	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.

Primary Outcome Measures

Name	Time	Method
primary outcome will be need for endotracheal intubation within 48 hours of admission	48 hours of patient admission to ICU.	Need for endotracheal intubation within 48 hours of admission to ICU

Secondary Outcome Measures

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