High Flow Nasal Cannula in Immunocompromised Patient With Acute

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04293991
Study type	Interventional
Source	Ain Shams University
Contact	Ashraf Elagamy, MD
Phone	002022470193
Email	elagamy_ashraf@yahoo.com
Status	Not yet recruiting
Phase	N/A
Start date	March 2020
Completion date	August 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

High Flow Nasal Cannula in Immunocompromised Patient With Acute Respiratory Failure

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms