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HypoxemiaTHIFONNCT03865056

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

A study testing Optiflow (High-flow Nasal Cannula) and Non-invasive Ventilation in people with Hypoxemia, run by University Health Network, Toronto.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Hypoxemia
What is being tested?
Optiflow (High-flow Nasal Cannula) and Non-invasive Ventilation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
15 Mar 2019to 15 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hypoxemia defined by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2:FiO2) ≤ 300 while the patient is breathing oxygen through NHF for at least 15 minutes;
  • Respiratory rate > 25 breaths/minute;
  • Partial pressure of arterial carbon dioxide (PaCO2) ≤ 45 mmHg;
  • Absence of clinical history of underlying chronic respiratory failure.

Who cannot join

  • Lack of consent;
  • Age < 18 years;
  • Invasive mechanical ventilation for > 48 hours in the same hospital admission
  • Immediate need for intubation;
  • Previous inclusion in the present study;
  • Systolic arterial pressure < 90 mmHg after optimal fluid therapy;
Show all 11Show fewer
  • Cardiogenic pulmonary edema;
  • Glasgow Coma Scale < 12;
  • Imminent death;
  • Contraindications to noninvasive ventilation;
  • Tracheostomy.

Trial locations and contacts

No sites are listed yet.

About this study

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).

Read more

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).

Conditions
Hypoxemia
Being tested
Optiflow (High-flow Nasal Cannula), Non-invasive Ventilation
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optiflow (High-flow Nasal Cannula)Device

    Also called Optiflow

    Optiflow will be applied for 20 minutes

  • Non-invasive VentilationDevice

    non-invasive ventilation will be applied for 20 minutes

Study groups in NCT03865056
Study groupRoleWhat they receive
High-Flow Nasal CannulaExperimentalNot described
Receives: Device: Optiflow (High-flow Nasal Cannula)
Noninvasive ventilationExperimentalNot described
Receives: Device: Non-invasive Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the intra-tidal ventilation heterogeneity index

    the intra-tidal ventilation heterogeneity index (VtHit) assessed by electrical impedance tomography (EIT)

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2019
  2. Study start15 Mar 2019 (estimated)
  3. Primary completion15 Mar 2021 (estimated)
  4. Study completion15 Mar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03865056
Sponsor's protocol ID
18-6194
Acronym
THIFON
Status last verified
Mar 2019
First submitted
5 Mar 2019
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Optiflow (High-flow Nasal Cannula) and Non-invasive Ventilation in people with Hypoxemia, run by University Health Network, Toronto.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact L:orenzo Del Sorbo, MD (416-340-4800 ext. 8009, lorenzo.delsorbo@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the intra-tidal ventilation heterogeneity index (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.

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