NCT05092737

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 3, 2022

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

October 21, 2021

Last Update Submit

June 2, 2022

Conditions

ARDSSars-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

  • PaO2/FiO2

    Arterial partial pressure of oxygen / Fraction of inspired oxygen

    Within 2 hours before pronation and 2 hours before supination

Secondary Outcomes (3)

  • 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

  • Mortality or Extracorporeal membrane oxygenation (ECMO) support

    Once between ICU admission and extubation

Interventions

Prone positioningPROCEDURE

Prone position during invasive mechanical ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

COVID-19

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2021

First Posted

October 25, 2021

Study Start

August 1, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

June 3, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)