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Awake Pronation for Covid-19 Treatment

Primary Purpose

Covid-19 Infection

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Prone Position (PP)
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 Infection

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • confirmed COVID-19 infection using PCR
  • Acute Respiratory Failure ( 200 <PaO2/FiO2 <300) and respiratory rate < 30 atti/min
  • O2 therapy initiated <72 hrs
  • informed consent

Exclusion Criteria:

  • Glasgow Coma Scale (GCS) < 13
  • pH< 7,45, PaCO2 >45 mmHg
  • need for HFNC, CPAP, NIV or intubation
  • hemodynamic instability increase of 80-90 mmHg or reduction of 30-40 mmHg in systolic blood pressure
  • severe arrythmia of myocardial infarction
  • need for sedation
  • intolerance to PP
  • pregnancy
  • Body mass index (BMI) > 35 kg/m2.

Sites / Locations

  • Sant'Orsola MalpighiRecruiting
  • Bolzano HospitalRecruiting
  • University of ModenaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxygen and Prone Position (PP)

Oxygen

Arm Description

Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96% plus PP for a minimum of 10 hrs a day

Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96%

Outcomes

Primary Outcome Measures

number of day free of ventilatory support
number of days in which the patient will not need (according to standardized criterai) any for of these ventilatory support like NIV,CPAP, HFNC or intubation

Secondary Outcome Measures

changes in respiratory pattern
recording of tidal volume (when possible) and respiratory frequency
daily changes in the ratio SaO2/FiO2
Daily changes in oxygen saturation (SaO2) and Fraction of Inspired Oxygen (FiO2)
dyspnea
using a dedicated scale (i.e. Borg numbered from 0 to 10)
comfort during PP
using a dedicated visual analog scale (VAS with a lenght of 20 cm)

Full Information

First Posted
December 11, 2020
Last Updated
April 15, 2021
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
Azienda Unità Sanitaria Locale Reggio Emilia, Azienda Ospedaliera di Bolzano, Azienda Ospedaliero-Universitaria di Modena
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1. Study Identification

Unique Protocol Identification Number
NCT04667286
Brief Title
Awake Pronation for Covid-19 Treatment
Official Title
Pronation in Spontaneously Breathing Patients With Acute Respiratory Failure Deu to Covid-19: Multicenter, Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 16, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
Azienda Unità Sanitaria Locale Reggio Emilia, Azienda Ospedaliera di Bolzano, Azienda Ospedaliero-Universitaria di Modena

4. Oversight

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

5. Study Description

Brief Summary
Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection. None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion
Detailed Description
Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection. These studies were mainly physiological and reported in a subset of patients a poor tolerance. Indeed most of the beneficial effects on gas exchage disappeared in around 40% of tyhe patients, once the patients regained the supine position. None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion. This holds particularly true in those patients affected by mild de-novo ARF (PaO2/FiO2 ratio within the range of 200-300), where any form of respiratory support like Continuous Positive Airways Pressure (CPAP), High Flow Nasal Cannula (HFNC) or Noninvasive ventilation (NIV), may be not yet indicated, especially if the patients are admitted to a regular ward as for the case of Covid-19 pandemics, due to the lack of "protected" beds.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxygen and Prone Position (PP)
Arm Type
Experimental
Arm Description
Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96% plus PP for a minimum of 10 hrs a day
Arm Title
Oxygen
Arm Type
Active Comparator
Arm Description
Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96%
Intervention Type
Procedure
Intervention Name(s)
Prone Position (PP)
Intervention Description
Prone the patients on oxygen for at least 10 hrs a day
Primary Outcome Measure Information:
Title
number of day free of ventilatory support
Description
number of days in which the patient will not need (according to standardized criterai) any for of these ventilatory support like NIV,CPAP, HFNC or intubation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
changes in respiratory pattern
Description
recording of tidal volume (when possible) and respiratory frequency
Time Frame
1 month
Title
daily changes in the ratio SaO2/FiO2
Description
Daily changes in oxygen saturation (SaO2) and Fraction of Inspired Oxygen (FiO2)
Time Frame
1 month
Title
dyspnea
Description
using a dedicated scale (i.e. Borg numbered from 0 to 10)
Time Frame
1 month
Title
comfort during PP
Description
using a dedicated visual analog scale (VAS with a lenght of 20 cm)
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
number of hours on PP
Description
recording of the actual time spent in PP
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: confirmed COVID-19 infection using PCR Acute Respiratory Failure ( 200 <PaO2/FiO2 <300) and respiratory rate < 30 atti/min O2 therapy initiated <72 hrs informed consent Exclusion Criteria: Glasgow Coma Scale (GCS) < 13 pH< 7,45, PaCO2 >45 mmHg need for HFNC, CPAP, NIV or intubation hemodynamic instability increase of 80-90 mmHg or reduction of 30-40 mmHg in systolic blood pressure severe arrythmia of myocardial infarction need for sedation intolerance to PP pregnancy Body mass index (BMI) > 35 kg/m2.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
stefano nava
Phone
+393333751828
Email
stefanava@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
stefano nava
Phone
+3930512144454
Email
stefanava@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stefano nava, MD
Organizational Affiliation
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40185
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Nava, MD
Facility Name
Bolzano Hospital
City
Bolzano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
roberto dongilli
Facility Name
University of Modena
City
Modena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
enrico clini

12. IPD Sharing Statement

Plan to Share IPD
No

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Awake Pronation for Covid-19 Treatment

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