MedTrace Logo

HFNT vs. COT in COVID-19

NCT04655638 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2021-10-26

No results posted yet for this study

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.

Conditions

  • Covid19
  • Acute Respiratory Failure

Interventions

DEVICE

High Flow Nasal Therapy

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%.

DEVICE

Conventional Oxygen Therapy

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%.

Sponsors & Collaborators

  • Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

    collaborator OTHER

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

    lead OTHER

Principal Investigators

  • Andrea Cortegiani, MD · University of Palermo. Azienda Ospedaliera Policlinico Paolo Giaccone

  • Claudia Crimi, MD · Respiratory Medicine Unit, "Policlinico-Vittorio Emanuele San Marco" University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2021-09-22
Completion
2021-10-25

Countries

  • Greece
  • Italy
  • Poland
  • Portugal
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04655638 on ClinicalTrials.gov