High Flow Nasal Cannula in Immunocompromised Patient With Acute Respiratory Failure

NCT04293991 | Unknown

• 1 other identifier: FMASU R 9 / 2020
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

High flow nasal cannula, .; Non invasive ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• secondary outcome will be mortality rate after 28 days of admission.

  28 days after patient admission to ICU.

Study Arms (2)

High flow nasal cannula (HFNC) group

ACTIVE COMPARATOR

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.

Device: High Flow Nasal Cannula

Non invasive ventilation (NIV) group

ACTIVE COMPARATOR

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%.

Device: Non Invasive Ventilation

Interventions

High Flow Nasal Cannula DEVICE

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

High flow nasal cannula (HFNC) group

Non Invasive Ventilation DEVICE

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

Non invasive ventilation (NIV) group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Hematological malignancies.
• Post bone marrow transplantation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Sameh Salem, MD

  Professor Doctor

  STUDY DIRECTOR

Central Study Contacts

Ashraf Elagamy, MD

CONTACT

002022470193; elagamy_ashraf@yahoo.com

Dalia Elfawy

CONTACT

daliamfawy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor Anesthesia,Intensive care and pain management

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: March 3, 2020
• Study Start: March 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share