NCT05060926

Brief Summary

Retrospective study in Sars-Cov 2 patients hospitalised in ICU. We aim to explore the effects of Awake prone positioning on oxygenation and intubation rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 16, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
7 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

September 1, 2021

Enrollment Period

8 months

First QC Date

September 16, 2021

Last Update Submit

June 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intubation rate

    Once between ICU admission and extubation

Secondary Outcomes (4)

  • Alveolo-arterial gradient change

    Within 6 hours before and 6 hours after each pronation

  • Blood gas analysis

    Within 6 hours before and 6 hours after each pronation

  • Respiratory pattern

    Within 6 hours before and 6 hours after each pronation

  • Mortality

    Up to 28 days from ICU admission

Interventions

Awake prone position as long as possible according to the patients' tolerance

Eligibility Criteria

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

Sars-CoV-2 pneumonia patients with severe hypoxemia

You may qualify if:

  • Sars-CoV-2 pneumonia
  • ICU stay
  • Severe hypoxemia but non intubated

You may not qualify if:

  • Intubated before admission
  • Denied consent for data analysis
  • Do not intubate order at ICU admission

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

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

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

September 16, 2021

First Posted

September 29, 2021

Study Start

September 16, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

June 3, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations