High Flow Nasal Cannula in Immunocompromised Patient With Acute Respiratory Failure

NCT ID: NCT04293991

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2020-08-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

High Flow Nasal Cannula

Intervention Type: DEVICE

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

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%.

Group Type: ACTIVE_COMPARATOR

Non Invasive Ventilation

Intervention Type: DEVICE

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

Interventions

High Flow Nasal Cannula

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

Intervention Type: DEVICE

Non Invasive Ventilation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ashraf Elsayed Elagamy

Assisstant professor Anesthesia,Intensive care and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameh Salem, MD

Role: STUDY_DIRECTOR

Professor Doctor

Central Contacts

Ashraf Elagamy, MD

Role: CONTACT

elagamy_ashraf@yahoo.com

002022470193

Dalia Elfawy

Role: CONTACT

daliamfawy@yahoo.com

Other Identifiers

FMASU R 9 / 2020

Identifier Type: -

Identifier Source: org_study_id