NCT04698083

Brief Summary

In patients with coronavirus disease (COVID-19), severe dyspnea is the most dramatic complication.Severe respiratory difficulties may include electrocardiographic frontal QRS axis rightward shift (Rws) and clockwise rotation (Cwr). This study investigated the predictability of advanced lung tomography findings with QRS axis shift and rotation. This was a retrospective analysis of 160 patients.The patients were divided into two groups: normal oxygen saturation(SpO2) (NS; n = 80) and low SpO2(LS;n = 80).They were then divided into NS Rws (n = 37), NS leftward shift (Lws; n = 43), LS Rws (n = 40), and LS Lws (n = 40) according to electrocardiographic follow-up findings. These groups were compared in terms of electrocardiographic rotation (Cwr, counterclockwise rotation, or normal transition), tomographic stage (CO-RADS5(advanced)/CO-RADS1-4), electrocardiographic intervals, and laboratory findings

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

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

July 22, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

January 4, 2021

Last Update Submit

January 5, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Differences in the electrocardiographic QRS axis shift(°),

    Differences in the axis shift between the Rws and Lws groups in patients with NS /LS groups.

    10-15 days

  • Differences in the electrocardiographic rotation

    Differences in clockwise,counterclockwise,normal transition between the groups.

    10-15 days

  • Differences in the CO-RADS5/CO-RADS1-4 ratio

    Differences in the CO-RADS5/CO-RADS1-4 ratio between the groups.

    10-15 days

Study Arms (2)

Group1:normal SpO2(NS,n = 80) and low SpO2(LS, n = 80).

Patients with normal oxygen saturation (SpO2; ≥ 90%) who did not receive oxygen therapy and patients with low SpO2(\<90%) who received nasal oxygen therapy were included in this study

Diagnostic Test: Electrocardiography ,Tomographic imaging

Group2:Rightward axis shift(Rws) and Leftward axis shift (Lws)

Both groups were divided into two main subgroups:patients with Rws and patients with leftward shift(Lws) of the QRS axis.The patient numbers were as follows: NS Rws (n=37),NS Lws(n=43),LS Rws (n=40),andLS Lws (n=40)

Diagnostic Test: Electrocardiography ,Tomographic imaging

Interventions

Based on electrocardiographic follow-up analyses,the two main groups were compared in terms of rotation condition (i.e., Cwr, normal transition, or CCwr), electrocardiographic intervals, and laboratory findings In our study,CO-RADS5 was considered an advanced tomographic finding(e.g., multifocal ground glass opacities with consolidation, vascular thickening,crazy paving pattern,mixed pattern),while CO-RADS1,2,3, and 4 were considered non-advanced tomographic findings.

Group1:normal SpO2(NS,n = 80) and low SpO2(LS, n = 80).Group2:Rightward axis shift(Rws) and Leftward axis shift (Lws)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients with dyspnea and COVID-19

You may qualify if:

  • Hospitalized patients with dyspnea and COVID-19

You may not qualify if:

  • Patients who received positive pressurized oxygen therapy Patients who underwent mechanical ventilation, Atrial fibrillation Complete bundle branch block Significant arrhythmias(complete atrioventricular block, polymorphic ventricular tachycardia, and ventricular fibrillation), Wolff-Parkinson-White syndrome, supraventricular tachycardia Unclear QRS axis orientation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şahbender Koç

Ankara, 06530, Turkey (Türkiye)

Location

Related Publications (1)

  • Koc S, Bozkaya VO, Yikilgan AB. Electrocardiographic QRS axis shift, rotation and COVID-19. Niger J Clin Pract. 2022 Apr;25(4):415-424. doi: 10.4103/njcp.njcp_9_21.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Şahbender Koç

    University of Health Sciences Ankara Keçiören Education Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardıologist

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

July 22, 2020

Primary Completion

October 15, 2020

Study Completion

November 5, 2020

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations