Clinical Trials Logo

Clinical Trial Summary

This Randomized Control Trial will directly compare helmet non-invasive ventilation (NIV) combined with high flow nasal oxygen (HFNO) versus HFNO alone in patients with Acute Hypoxemic Respiratory Failure (AHRF).


Clinical Trial Description

This is a pilot multicentre, concealed, stratified, permuted block randomized controlled trial enrolling patients with AHRF who are admitted to the intensive care unit. Patients with imminent need for intubation, or a contraindication to study interventions will be excluded. Patients will be randomized to receive either (1) sessions of at least 12 hours per day of helmet NIV oxygen interspersed with HFNO or (2) HFNO alone over at least 2 calendar days. Participants will be followed to hospital discharge or 60 days, with an additional quality of life assessment via telephone interview 6 months after enrolment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05078034
Study type Interventional
Source Sunnybrook Health Sciences Centre
Contact Damon Scales, MD PhD FRCPC
Phone 416-480-5291
Email damon.scales@sunnybrook.ca
Status Recruiting
Phase N/A
Start date March 17, 2022
Completion date February 1, 2024

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06007495 - Pilot Physiological Evaluation of an Investigational Mask With Expiratory Washout. N/A
Completed NCT05060926 - Intubation Prediction in COVID-19 Patients Treated With Awake Prone Positioning
Recruiting NCT05203536 - Respiratory Mechanics Assessment During Assisted Mechanical Ventilation
Completed NCT04570384 - Intravenous L-Citrulline Influence on the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients With COVID-19 Phase 2
Not yet recruiting NCT05499039 - High Flow Nasal Cannula Versus Non-Invasive (NIV)in Both Hypoxemic and Hypercapnic Respiratory Failure. N/A
Completed NCT04568642 - Comparing Closed-loop FiO2 Controller With Conventional Control of FiO2 N/A
Completed NCT03653806 - Automated Analysis of EIT Data for PEEP Setting
Completed NCT01747109 - Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study N/A
Terminated NCT04632043 - Early Versus Delayed Intubation of Patients With COVID-19 N/A
Completed NCT04581811 - Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS) N/A
Not yet recruiting NCT06064409 - Optimal Timing and Failure Prediction of High Flow Nasal Cannula Oxygen Therapy in Emergency Department: Prospective Observational Single Center Study
Completed NCT03133520 - Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure N/A
Recruiting NCT04997265 - Strategies for Anticoagulation During Venovenous ECMO N/A
Completed NCT05083130 - Awake Prone Positioning in Moderate to Severe COVID-19 N/A
Recruiting NCT03513809 - Inflammation and Distribution of Pulmonary Ventilation Before and After Tracheal Intubation in ARDS Patients
Terminated NCT04395807 - Helmet CPAP Versus HFNC in COVID-19 N/A
Completed NCT00578734 - Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old Phase 2
Recruiting NCT00342368 - Helmet CPAP vs Venturi O2 to Treat Early ALI/ARDS N/A
Recruiting NCT06042036 - Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation in Patients With Acute Respiratory Failure
Not yet recruiting NCT03919331 - Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo N/A