Physiological Response to Prone Position in COVID-19 Asso... | NCT05092737

Studies
Physiological Response to Prone Position in COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS)

NCT05092737

Sponsor

University of Lausanne Hospitals

Status

Completed

Last Update Posted

Jun 3, 2022Actual

Enrollment

31Actual

Phase

Not provided

Conditions

ARDS
Sars-CoV-2 Infection

Interventions

Prone positioning

Countries

Switzerland

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

Oct 2021

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

Aug 1, 2021Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Oct 21, 2021

First Submission Date that Met QC Criteria

Oct 21, 2021

First Posted Date

Oct 25, 2021Actual

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

Jun 2, 2022

Last Update Posted Date

Jun 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Piquilloud Imboden Lise, Principal Investigator, University of Lausanne HospitalsPrincipal Investigator

Lead Sponsor

University of Lausanne HospitalsOTHER

Collaborators

Not provided

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

Retrospective study in COVID-19 ARDS patients hospitalised in the ICU. Investigators aim to explore the effects of prone positioning on oxygenation, dead space ventilation and mortality.

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

31Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prone positioning	Procedure	Prone position during invasive mechanical ventilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PaO2/FiO2	Arterial partial pressure of oxygen / Fraction of inspired oxygen	Within 2 hours before pronation and 2 hours before supination

Secondary Outcomes

Measure	Description	Time Frame
Alveolo-arterial oxygen gradient change		Within 2 hours before pronation and 2 hours before supination
Ventilatory Ratio		Within 2 hours before pronation and 2 hours before supination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COVID-19 associated moderate to severe ARDS
Invasive mechanical ventilation
Prone positioning
admitted to ICU

Exclusion Criteria:

already sustained prone positioning in referring hospital
pronation during ECMO only
denied consent for data analysis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

COVID-19 moderate to severe ARDS patients who sustained prone positioning

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lausanne University Hospitals		Lausanne	Canton of Vaud	1011	Switzerland

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