CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 364 enrolled
Drug / intervention
High Flow Nasal Therapy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04655638
NCT04655638N/ACompleted
CompareCT.gov

High-Flow Nasal Therapy Versus Conventional Oxygen Therapy in Patients With COVID-19: A Randomized Controlled Trial (The COVID-HIGH Trial)

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo·interventional·Posted Dec 7, 2020·Updated Oct 26, 2021

In Brief

A clinical study evaluating High Flow Nasal Therapy and Conventional Oxygen Therapy for Covid19 and Acute Respiratory Failure. Completed, enrolled 364 participants across 27 sites in 6 countries.

Detailed Summary

The aim of this unblinded parallel-group randomized multicenter clinical trial is to compare the clinical effectiveness of high flow nasal therapy (HFNT) with conventional oxygen therapy (COT) in patients with confirmed COVID-19 related acute hypoxemic respiratory failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19, Acute Respiratory Failure
CountriesGreece, Italy, Poland, Portugal, Spain, Turkey (Türkiye)
CollaboratorsAzienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 7, 2020
Enrollment StartFeb 10, 2021
Primary CompletionSep 22, 2021
Study CompletionOct 25, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.6 years ago

Interventions

High Flow Nasal Therapydevice

High flow nasal therapy will be delivered by any device (standalone machine or ventilators able to deliver it). The initial flow rate will be set at 40 L/min and potentially increased up to 60 L/min, according to patient tolerance. Large-bore nasal prongs will be selected according to the size of patients' nostrils (i.e. 2/3 of the diameter of the patient's nostril). A surgical mask will be placed on top of the HFNT interface. The temperature will be set at 37°C or 34 °C according to the patient's comfort. The FiO2 will be adjusted to maintain SpO2 between 92-96%.

Conventional Oxygen Therapydevice

Conventional Oxygen therapy will be delivered by any device or combination of devices used for delivering oxygen such as nasal cannula, Venturi Mask or Mask with or without a reservoir bag as per usual local practice. Oxygen flow will be titrated to achieve SpO2 between 92-96%.