High Flow Nasal Cannula in Immunocompromised Patient With Acute Respiratory Failure

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04293991
• Other study ID #: FMASU R 9 / 2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: August 2020

Study information

• Verified date: February 2020
• Source: Ain Shams University
• Contact: Ashraf Elagamy, MD
• Phone: 002022470193
• Email: elagamy_ashraf[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

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).

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: August 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• High Flow Nasal Cannula
• Non Invasive Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• High Flow Nasal Cannula
Evaluate the use of HFNC in prevention of intubation in immunocompromised patients adimitted to icu.
• Non Invasive Ventilation
Evaluate the use of HFNC in prevention of intubation in immunocompromised patient admitted to icu.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.