HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Oct 1, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to help patients who are experiencing a serious breathing problem called Acute Hypoxemic Respiratory Failure (AHRF). The researchers want to see if using a special helmet that provides non-invasive ventilation (NIV) along with high flow nasal oxygen (HFNO) is more effective than using HFNO alone. This study is important because it aims to improve how we support breathing in patients who are struggling to get enough oxygen.

To be eligible to participate, patients should be at least 18 years old, currently admitted to the intensive care unit, and have been experiencing breathing difficulties for at least an hour. They should not already be on certain types of breathing support or need immediate intubation (a procedure where a tube is placed in the throat to help with breathing). If someone joins the trial, they will receive either the helmet with NIV and HFNO or just HFNO alone, and the care team will monitor their breathing and oxygen levels closely. This trial is currently recruiting participants and aims to find the best way to support patients in critical need of oxygen.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Intensive care unit admission (orders written)
• • 2. Age ≥18 years
• 3. Hypoxemic acute respiratory failure for at least 1 hour and still present at time of screening for eligibility (symptom onset during last 14 days) with the following:
• • 1. Respiratory rate \>21bpm or clinical evidence of increased work of breathing and
• 2. Documented Hypoxemia defined as any one of:
• • i. PaO2:FiO2 \< 300 ii. If no arterial blood gas available, then SpO2:FiO2 \< 315 iii. Oxygen saturation \<98% on FiO2 \>= 0.4 or higher by Venturi mask, TAVISH mask 10 Litres / minute, or any non-invasive oxygenation strategy
• • 4. Not already intubated or with tracheostomy
• Exclusion Criteria:
• • 1. Already on HFNO or other non-invasive ventilation strategy at FiO2\>=0.4 for the last 24 hours in the ICU.
• • 2. Immediate need for intubation (e.g., inadequate airway protection or refractory hypoxemia or cardiopulmonary arrest, massive hemoptysis, etc)
• • 3. Extubated in the ICU within past 72 hours
• • 4. Clinician deems that face mask NIV is indicated to treat a primary diagnosis of hypercapnic respiratory failure or acute congestive heart failure
• • 5. Known neuromuscular disease
• • 6. Patients being transitioned to Palliative care or unlikely to survive more than 24 hours
• • 7. ICU discharge is planned or anticipated on the day of screening
• • 8. Previously enrolled in this trial
• • 9. Trauma patients who remain in a cervical spine collar at the time of recruitment or who have upper limb/torso fractures that would preclude them from safe application of the helmet
• • 10. Clinician decision that positive pressure to face and/or nasal pharynx is a contraindication (eg. Transphenoidal surgery, basal skull fracture etc.)