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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04293991
Enrollment
76
Registered
2020-03-03
Start date
2020-03-31
Completion date
2020-08-31
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

High flow nasal cannula, ., Non invasive ventilation

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

Interventions

DEVICEHigh Flow Nasal Cannula

Evaluate the use of HFNC in prevention of intubation in immunocompromised patients adimitted to icu.

DEVICENon Invasive Ventilation

Evaluate the use of HFNC in prevention of intubation in immunocompromised patient admitted to icu.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
primary outcome will be need for endotracheal intubation within 48 hours of admission48 hours of patient admission to ICU.Need for endotracheal intubation within 48 hours of admission to ICU

Secondary

MeasureTime frameDescription
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.

Contacts

Primary ContactAshraf Elagamy, MD
elagamy_ashraf@yahoo.com002022470193
Backup ContactDalia Elfawy
daliamfawy@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026