NCT04432051

Brief Summary

In COVID-19 patients hospitalized in the intensive care unit due to respiratory failure, lung ultrasonography will be tried to be given an appropriate position that will effectively use lung capacity and its effect on oxygenation will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

May 26, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2020

Completed
Last Updated

December 22, 2022

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

June 11, 2020

Last Update Submit

December 21, 2022

Conditions

Keywords

lung ultrasonographyintensive care unitpositionCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Change in PO2 values

    Effect of positioning on ultrasound guidance on oxygenation assessed by changes between pO2 values.

    12 hours

Secondary Outcomes (1)

  • Change in PCO2 values

    12 hours

Study Arms (2)

GRUP Control

PLACEBO COMPARATOR

The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis.

Behavioral: mechanical ventilator settings and position

GRUP Ultrasonography

ACTIVE COMPARATOR

The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis. However, the lung of the patient will be evaluated by ultrasound and the position to use the lung capacity most appropriately will be given.

Behavioral: mechanical ventilator settings and position

Interventions

Mechanical ventilation settings and patient position will be re-evaluated

GRUP ControlGRUP Ultrasonography

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients have been diagnosed with COVID 19
  • Patients in the intensive care unit over the age of 18

You may not qualify if:

  • Patients not diagnosed with COVID 19
  • Patients with cardiac problems
  • Patients with renal problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazoosmanpasa Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: patients will be divided into two groups, those with and without ultrasound.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 16, 2020

Study Start

May 26, 2020

Primary Completion

August 8, 2020

Study Completion

August 10, 2020

Last Updated

December 22, 2022

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations