Pronation in COVID-19 Patients Undergoing Non Invasive Re... | NCT04649658

Studies
Pronation in COVID-19 Patients Undergoing Non Invasive Respiratory Support

NCT04649658

Sponsor

University of Modena and Reggio Emilia

Status

Completed

Last Update Posted

Dec 14, 2020Actual

Enrollment

93Actual

Phase

Not provided

Conditions

Covid19

Interventions

Prone position

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

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Nov 30, 2020Actual

First Submitted Date

Nov 30, 2020

First Submission Date that Met QC Criteria

Nov 30, 2020

First Posted Date

Dec 2, 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

Dec 11, 2020

Last Update Posted Date

Dec 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Pronation seems feasible and effective in improving blood oxygenation in patients with COVID-19 pneumonia. Data are lacking on the effects of pronation on clinical outcome in this subset of patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prone position		Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to prone position	Behavioral: Prone position
Standard care		Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prone position	Behavioral	Prone position maintained at least 3 hours/day	Prone position

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endotracheal intubation		28 days

Secondary Outcomes

Measure	Description	Time Frame
Mortality		28 days
Tracheostomy		28 days
Length of Respiratory Intensive Care Unit stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion Criteria

patients aged ≥18 and < 80 years old
acute respiratory failure

Exclusion Criteria:

endotracheal intubation performed within the first 24 hours from admission,
ceiling of escalation of intensive care
do not intubate order as expressed by patient willing or upon clinical judgement
missing core data at medical record analysis (clinical features at baseline, pronation information, type and time of ventilatory support required, mortality, need for tracheostomy, length of respiratory intensive care unit and hospital stay).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients aged ≥18 and < 80 years old admitted to the two respiratory intensive care units for severe and critical COVID-19 pneumonia between March 1st, 2020 and June 1st, 2020.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliero Universitaria Policlinico di Modena		Modena			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
D012131	Respiratory Insufficiency

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