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

Primary Purpose

COVID, ARDS, Acute Respiratory Distress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Prone position
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID focused on measuring PRONE POSITION, High flow nasal cannula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Vall d'HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

Combination of prone position and HFNC

Standard care: HFNC set for a SpO2 90-95% if unless indication for intubation is present.

Outcomes

Primary Outcome Measures

Therapeutic failure death or intubation
Therapeutic failure: death or intubation

Secondary Outcome Measures

Feasibility and safety of prone position in HFNC patients
Comfort measurement using a visual-analog scale. Presence of complications related with prone position and the use of high-flow nasal cannula: Skin ulcers. Intravascular lines displacement HFNC related events (hot air feeling, nasal lesions)
Efficacy of prone position in HFNC patients
Evolution of the oxygenation (SpO2/FiO2) in prone position. Efficacy Length of HFNC therapy Length of ICU stay Length of mechanical ventilation (in those who require intubation) ICU and hospital mortality

Full Information

First Posted
May 10, 2020
Last Updated
August 14, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04391140
Brief Title
Prone Positioning and High-flow Nasal Cannula in COVID-19 Induced ARDS
Official Title
Effectiveness of Prone Positioning Combined With High-flow Nasal Cannula for Patients With COVID-19 Induced ARDS
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 13, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, ARDS, Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Corona Virus Infection
Keywords
PRONE POSITION, High flow nasal cannula

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Combination of prone position and HFNC
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care: HFNC set for a SpO2 90-95% if unless indication for intubation is present.
Intervention Type
Other
Intervention Name(s)
Prone position
Intervention Description
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.
Primary Outcome Measure Information:
Title
Therapeutic failure death or intubation
Description
Therapeutic failure: death or intubation
Time Frame
28 days within randomization
Secondary Outcome Measure Information:
Title
Feasibility and safety of prone position in HFNC patients
Description
Comfort measurement using a visual-analog scale. Presence of complications related with prone position and the use of high-flow nasal cannula: Skin ulcers. Intravascular lines displacement HFNC related events (hot air feeling, nasal lesions)
Time Frame
28 days within randomization
Title
Efficacy of prone position in HFNC patients
Description
Evolution of the oxygenation (SpO2/FiO2) in prone position. Efficacy Length of HFNC therapy Length of ICU stay Length of mechanical ventilation (in those who require intubation) ICU and hospital mortality
Time Frame
28 days within randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oriol Roca, MD PhD
Phone
+34 93 274 62 09
Email
oroca@vhebron.net
First Name & Middle Initial & Last Name & Degree
Marina García-de-Acilu, MD
Phone
+34 93 274 62 09
Email
maringar@vhebron.net
First Name & Middle Initial & Last Name & Degree
Oriol Roca, MD PhD
First Name & Middle Initial & Last Name & Degree
Marina García-de-Acilu, MD
First Name & Middle Initial & Last Name & Degree
Cesar Laborda, MD
First Name & Middle Initial & Last Name & Degree
Judit Sacanell, MD
First Name & Middle Initial & Last Name & Degree
Jordi Riera, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
34425070
Citation
Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
Results Reference
derived
PubMed Identifier
33177145
Citation
Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.
Results Reference
derived

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

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