NCT03865056: THIFON

Therapy With High-flow Oxygen by Nasal Cannula vs Noninvasive Ventilation in Patients With Acute Hypoxemic Respiratory Failure: a Crossover Physiologic Study

Status unknown NA Last updated 6 March 2019

What this trial tests

NA trial testing Optiflow (High-flow Nasal Cannula) in Hypoxemia in 20 participants. Status unknown.

Timeline

15 March 2019

Primary endpoint
15 March 2021

15 March 2021

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	15 March 2019
Primary completion	15 March 2021
Estimated completion	15 March 2021

Drugs / interventions tested

• Optiflow (High-flow Nasal Cannula)
• Non-invasive Ventilation

Conditions studied

• Hypoxemia — all drugs for Hypoxemia →

Sponsor

University Health Network, Toronto

Who can join

Adults 18 to 100, any sex, with Hypoxemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background and rationale: A large multicenter randomized controlled trial demonstrated that in patients with hypoxemic non-hypercapnic respiratory failure treatment with nasal high flow oxygen (NHF) resulted in a reduction of the endotracheal intubation rate (38%) compared with noninvasive ventilation (NIV) delivered by facemask (50%) or with conventional oxygen therapy (47%), although the difference was not statistically significant. These results could be potentially explained by the physiological benefits provided by the NHF. However, one of the surprising findings of this study was that patients randomized to the facemask NIV group had a similar or even poorer outcome than oxygen alone. Interestingly, an observational study showed that in patients receiving facemask NIV for acute hypoxemia delivered tidal volumes were higher than expected (8.1-11.1 ml/kg predicted body weight), suggesting that NIV could potentially cause ventilator-induced lung injury resulting in worsening respiratory failure.

We, therefore, plan a crossover physiologic study investigating the hypothesis that compared with NIV the treatment with NHF of patients with acute hypoxemic non-hypercapnic respiratory failure results in a more homogeneous distribution of tidal volume, and hence less ventilator-induced lung injury, as measured by electrical impedance tomography (EIT).

Methods: This physiologic study will enroll 20 patients from the ICU at Toronto General Hospital in one year. Adult patients with acute hypoxemic non cardiogenic respiratory failure and PaO2:FiO2 ≤ 300 mmHg, respiratory rate \> 25 breaths/minute, PaCO2 ≤ 45 mmHg and absence of clinical history of underlying chronic respiratory failure will be eligible. Patients that received invasive mechanical ventilation for \> 48 hours in the same hospital admission, requiring immediate intubation, with hemodynamic instability (systolic arterial pressure \< 90 mmHg after optimal fluid therapy), with Glasgow Coma Scale \< 12, or contraindications to noninvasive ventilation and tracheostomy, will be excluded. After baseline assessment while receiving oxygen through facemask or nasal prongs, patients will receive in randomly assigned order NHF for 20 minutes and NIV for 20 minutes, in a crossover manner. EIT recordings, diaphragm ultrasound, and collection of blood samples for arterial blood gases will be performed at the end of each phase.

Data analysis: The primary endpoint is the comparison of the EIT intra-tidal ventilation index between treatment with NHF and NIV. As secondary endpoints, we will determine whether NHF, in comparison to NIV, provides respiratory support with lower global inhomogeneity index (EIT), lower tidal volumes, reduces respiratory muscle effort (respiratory rate and diaphragmatic ultrasound), and improves gas exchange (oxygen saturation, PaO2:FiO2, PaCO2, RR).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. High-flow nasal cannulae for respiratory support in adult intensive care patients.
   Corley A, Rickard CM, Aitken LM, Johnston A, et al · · 2017 · cited 44× · PMID 28555461 · DOI 10.1002/14651858.cd010172.pub2
2. High-flow nasal cannulae for respiratory support in adult intensive care patients.
   Lewis SR, Baker PE, Parker R, Smith AF. · · 2021 · cited 43× · PMID 33661521 · DOI 10.1002/14651858.cd010172.pub3