NCT04391140

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

May 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

August 18, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

May 10, 2020

Last Update Submit

August 14, 2020

Conditions

COVIDARDSAcute Respiratory Distress SyndromeAcute Respiratory FailureCorona Virus Infection

Keywords

PRONE POSITIONHigh flow nasal cannula

Outcome Measures

Primary Outcomes (1)

  • Therapeutic failure death or intubation

    Therapeutic failure: death or intubation

    28 days within randomization

Secondary Outcomes (2)

  • Feasibility and safety of prone position in HFNC patients

    28 days within randomization

  • Efficacy of prone position in HFNC patients

    28 days within randomization

Study Arms (2)

Experimental

EXPERIMENTAL

Combination of prone position and HFNC

Other: Prone position

Control

NO INTERVENTION

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

Interventions

Prone positionOTHER

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.

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Related Publications (2)

  • 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.

    PMID: 34425070DERIVED

  • 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.

    PMID: 33177145DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeCoronavirus Infections

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2020

First Posted

May 18, 2020

Study Start

May 13, 2020

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

August 18, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
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

Locations

ES(1)