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

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ClinicalTrials.gov Identifier: NCT04391140
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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.


Condition or disease Intervention/treatment Phase
COVID ARDS Acute Respiratory Distress Syndrome Acute Respiratory Failure Corona Virus Infection Other: Prone position Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Prone Positioning Combined With High-flow Nasal Cannula for Patients With COVID-19 Induced ARDS
Actual Study Start Date : May 13, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021


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.



Primary Outcome Measures :
  1. Therapeutic failure death or intubation [ Time Frame: 28 days within randomization ]
    Therapeutic failure: death or intubation


Secondary Outcome Measures :
  1. 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)

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391140


Locations
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Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Oriol Roca, MD PhD    +34 93 274 62 09    oroca@vhebron.net   
Contact: Marina García-de-Acilu, MD    +34 93 274 62 09    maringar@vhebron.net   
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         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT04391140    
Other Study ID Numbers: PR(AG)198/2020
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Supporting Materials: Study Protocol
Analytic Code
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
PRONE POSITION
High flow nasal cannula
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Virus Diseases
Lung Injury
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections