Prone Positioning and High-flow Nasal Cannula in COVID-19 Induced ARDS

August 14, 2020 updated by: Hospital Universitari Vall d'Hebron Research Institute

Effectiveness of Prone Positioning Combined With High-flow Nasal Cannula for Patients With COVID-19 Induced ARDS

Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients.

Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation.

Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation.

Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care.

Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Oriol Roca, MD PhD
        • Principal Investigator:
          • Marina García-de-Acilu, MD
        • Sub-Investigator:
          • Cesar Laborda, MD
        • Sub-Investigator:
          • Judit Sacanell, MD
        • Sub-Investigator:
          • Jordi Riera, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • COVID-19 pneumonia according to the diagnostic criteria in effect at the time of inclusion or very strongly suspected.
  • Patient treated by nasal high flow.
  • Moderate or severe ARDS: bilateral radiological opacities not explained entirely by effusions, atelectasis or nodules; acute hypoxemia with worsening within the 7 previous days, not entirely explained by left ventricular failure; PaO2 / FiO2 ratio <300 mmHg (or SpO2 / FiO2 equivalent).
  • Informed consent.
  • Beneficiary or affiliated to a social security scheme.

Exclusion Criteria:

  • Indication of immediate tracheal intubation
  • Significant acute progressive circulatory insufficiency
  • Impaired alertness, confusion, restlessness
  • Body mass index> 40 kg / m2
  • Chest trauma or other contraindication to prone position
  • Pneumothorax
  • Vulnerable person: safeguard of justice
  • Pregnant or lactating woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Combination of prone position and HFNC
Other: Prone position
HFNC set to a SpO2 of 90-95% combined with prone position. At least 2 sessions of 30 minutes or more will be performed daily.
No Intervention: Control
Standard care: HFNC set for a SpO2 90-95% if unless indication for intubation is present.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic failure death or intubation
Time Frame: 28 days within randomization
Therapeutic failure: death or intubation
28 days within randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and safety of prone position in HFNC patients
Time Frame: 28 days within randomization
  1. Comfort measurement using a visual-analog scale.

  2. Presence of complications related with prone position and the use of high-flow nasal cannula:

    1. Skin ulcers.
    2. Intravascular lines displacement
    3. HFNC related events (hot air feeling, nasal lesions)
28 days within randomization
Efficacy of prone position in HFNC patients
Time Frame: 28 days within randomization
  1. Evolution of the oxygenation (SpO2/FiO2) in prone position.

  2. Efficacy

    1. Length of HFNC therapy
    2. Length of ICU stay
    3. Length of mechanical ventilation (in those who require intubation)
    4. ICU and hospital mortality
28 days within randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)198/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared to perform a meta-trial including other studies that assess the effectiveness of prone position in COVID-19 patients supported with nasal high flow.

No patient identifying data will be transferred to the data repository. The data set will use pseudoanonymised data. The consent process for the study will highlight that this is a meta-trial and that both aggregated and individual data without personal identifying features will be used to formulate the results from the study. Local regulation for the management of patient data needs to be adhered to as part of agreement for involvement in the study.

Data will be shared during the study at two points, Time 1 An interim analysis at 200 patients in which aggregated outcome data for the primary outcome and severe adverse effects will be analyzed

Time 2 Final analysis outlining salient clinical feature of patients for each group, outcomes

IPD Sharing Time Frame

Data will be shared when first 200 patients (counting the 5 studies participating in the meta-trial) will be included and at the end of inclusion

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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