NCT05677165

Brief Summary

By using Mechanical Power and Driving Pressure instead of Pmean we calculate new oxygen saturation indices like Driving Pressure Oxygen Index (OIDP), Dynamic Power Oxygen Index (OIMPdyn), Total Power Oxygen Index (OIMPtot), Driving Pressure Saturation Index (OSIDP), Dynamic Power Saturation Index (OSIMPdyn) ve Power Saturation Index (OSIMPtot). New oxygenation and saturation indices are able to predict ICU mortality better than the conventional indexes and rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 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

March 18, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
Last Updated

January 10, 2023

Status Verified

December 1, 2022

Enrollment Period

1.6 years

First QC Date

November 21, 2022

Last Update Submit

December 22, 2022

Conditions

Keywords

acute respiratory distress syndromepneumoniaoxygenation indexsaturation index

Outcome Measures

Primary Outcomes (1)

  • In hospital mortality

    we estimate hospital mortality mortality by calculating new oxygenation index

    28 days

Secondary Outcomes (1)

  • Mechanical ventilatory free days

    30 days

Eligibility Criteria

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

The data of 784 patients with a diagnosis of Covid-19 hospitalized in the 28-bed intensive care unit of the Bakirkoy Dr. Sadi Konuk Training and Research Hospital were obtained by using structured query language (sql) queries from the 'ImdSoft-Metavision/QlinICU Clinical Decision Support (Israel) system'.173 patients who did not receive invasive mechanical ventilation support, 64 patients who stayed in the intensive care unit for less than 24 hours, 40 patients with missing data, and 38 patients who received mechanical ventilation support for less than 24 hours were excluded from the study.24 patients with COPD, 27 patients with congestive heart failure, and 11 patients who underwent tube thoracostomy due to tension pneumothorax were excluded from the study.In addition, 46 patients who received ECMO support were excluded from the study due to the possibility that ECMO may have an effect on respiratory variables. The remaining 361 patients were included in the study.

You may qualify if:

  • \- Patients with a diagnosis of Covid-19 related Acute Respiratory Syndrome (C-ARDS) which hospitalized in Bakirköy Dr. Sadi Konuk Training and Research Hospital intensive care unit

You may not qualify if:

  • Patients who did not receive invasive mechanical ventilation support.
  • Patients who stayed in the intensive care unit for less than 24 hours.
  • Patients with missing data
  • Patients who received mechanical ventilation support for less than 24 hours
  • Patients with Chronic Obstructive Pulmonary Disease (COPD).
  • Patients with congestive heart failure
  • Patients who underwent tube thoracostomy due to tension pneumothorax
  • Patients who received Extracorporeal Membrane Oxygenation (ECMO) support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirköy Dr sadi konuk Education hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Distress SyndromePneumonia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersRespiratory Tract InfectionsInfections

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

January 10, 2023

Study Start

March 18, 2020

Primary Completion

November 1, 2021

Study Completion

November 28, 2021

Last Updated

January 10, 2023

Record last verified: 2022-12

Locations