Awake Pronation for Covid-19 Treatment | NCT04667286

Studies
Awake Pronation for Covid-19 Treatment

NCT04667286

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Unknown status

Last Update Posted

Apr 19, 2021Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Covid-19 Infection

Interventions

Prone Position (PP)

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2021Actual

Primary Completion Date

Jun 1, 2021Estimated

Completion Date

Jul 1, 2021Estimated

First Submitted Date

Dec 11, 2020

First Submission Date that Met QC Criteria

Dec 11, 2020

First Posted Date

Dec 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2021

Last Update Posted Date

Apr 19, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

dr. Stefano Nava, professor and chief of respiratory and critical care unit, IRCCS Azienda Ospedaliero-Universitaria di BolognaPrincipal Investigator

Lead Sponsor

IRCCS Azienda Ospedaliero-Universitaria di BolognaOTHER

Collaborators

Name	Class
Azienda USL Reggio Emilia - IRCCS	OTHER_GOV
Azienda Ospedaliera di Bolzano	OTHER
Azienda Ospedaliero-Universitaria di Modena	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxygen and Prone Position (PP)	Experimental	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	Procedure: Prone Position (PP)
Oxygen	Active Comparator	Oxygen via a Venturi mask in order to keep an oxygen saturation between 92 and 96%	Procedure: Prone Position (PP)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prone Position (PP)	Procedure	Prone the patients on oxygen for at least 10 hrs a day	Oxygen Oxygen and Prone Position (PP)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	1 month

Secondary Outcomes

Measure	Description	Time Frame
changes in respiratory pattern	recording of tidal volume (when possible) and respiratory frequency	1 month
daily changes in the ratio SaO2/FiO2	Daily changes in oxygen saturation (SaO2) and Fraction of Inspired Oxygen (FiO2)

Other Outcomes

Measure	Description	Time Frame
number of hours on PP	recording of the actual time spent in PP	1 month

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
stefano nava	Contact	+393333751828		stefanava@gmail.com
stefano nava	Contact	+3930512144454		stefanava@gmail.com

Overall Officials

Name	Affiliation	Role
stefano nava, MD	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sant'Orsola Malpighi	Recruiting	Bologna		40185	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016684	Prone Position

Ancestor Terms

ID	Term
D011187	Posture
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided