NCT04818164

Brief Summary

Covid-19 associated Acute Respiratory Distress Syndrome (ARDS) may present with profound hypoxemia not fully explained with pulmonary infiltrates. Accordingly, how prone positioning improves oxygenation in these patients is not fully known. The investigators conducted a study among patients with severe Covid-19 ARDS receiving prone position for at least 16 hours. End Expiratory Lung Volume (EELV) was measured with Nitrogen wash-in/wash-out technique before (Supine Position 1- SP1), during (Prone Position - PP) and after (Supine Position 2 - SP2) prone positioning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

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

September 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

March 25, 2021

Last Update Submit

March 3, 2022

Conditions

Keywords

acute respiratory distress syndromeprone positionlung recruitment

Outcome Measures

Primary Outcomes (2)

  • Partial Pressure of Oxygen/ Fraction of Inspired Oxygen

    Oxygenation

    1 day

  • End Expiratory Lung Volume

    Oxygenation

    1 day

Secondary Outcomes (2)

  • Lung Compliance

    1 day

  • Dead Space Ventilation

    1 day

Eligibility Criteria

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

Adult Patients receiving invasive mechanic ventilation due to Covid-19 ARDS

You may qualify if:

  • Patients were considered eligible if they met the Berlin definition criteria for ARDS and intubated due to increased work of breathing and/or worsening hypoxemia. All patients had a positive Covid-19 real time Polymerase Chain Reaction test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Dilken O, Rezoagli E, Yartas Dumanli G, Urkmez S, Demirkiran O, Dikmen Y. Effect of prone positioning on end-expiratory lung volume, strain and oxygenation change over time in COVID-19 acute respiratory distress syndrome: A prospective physiological study. Front Med (Lausanne). 2022 Dec 2;9:1056766. doi: 10.3389/fmed.2022.1056766. eCollection 2022.

MeSH Terms

Conditions

Respiratory Distress SyndromeCoronavirus Infections

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Olcay Dilken, Dr.

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 26, 2021

Study Start

September 1, 2020

Primary Completion

September 30, 2021

Study Completion

March 1, 2022

Last Updated

March 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations