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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04698083
Other study ID # 22/7/2020-2152
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 22, 2020
Est. completion date November 5, 2020

Study information

Verified date January 2021
Source Ankara Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

The lung is the most seriously damaged organ in patients with coronavirus disease (COVID-19). In patients with advanced lung involvement, the alveoli are filled with fluid, white blood cells, mucus, and damaged lung cell debris [1]. The electrical position of the heart in the frontal plane is defined as normal, right, left, or northwest quadrant axis deviation, while its position in the horizontal plane is defined as clockwise rotation (Cwr), normal transition, or counterclockwise rotation (Ccwr)[2]. As respiratory disease progresses,rightward shift(Rws) of the frontal QRS axis can result from Cwr of the heart around its longitudinal axis as viewed from the apex, sudden increase in pulmonary vascular resistance causing right ventricle dilatation, or both [3]. Electrocardiographic changes should be monitored intermittently, as this disease progresses rapidly to near 50% mortality within 7-28 days [4].The aim of this study was to investigate whether easily detectable electrocardiographic axis and rotation changes could predict advanced lung involvement[4]. Methods Study design Records of 250 hospitalized patients with dyspnea and COVID-19 were analyzed retrospectively.Patients were excluded if they received positive pressurized oxygen therapy(n:25),underwent mechanical ventilation,(n:15)exhibited atrial fibrillation(n:10), conditions precluding the assessment of QRS transitional rotation ;complete bundle branch block(n:10), significant arrhythmias(n:5,complete atrioventricular block(n:2), polymorphic ventricular tachycardia(n:2), and ventricular fibrillation), Wolff-Parkinson-White syndrome(n:1), supraventricular tachycardia(n:4), or had unclear QRS axis orientation(n:20). The remaining160 patients who had electronic medical records, nursing records,at least three electrocardiographic recordings taken a few days apart, and laboratory and tomographic findings were included in the study.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. Patients were divided into two groups: normal SpO2(NS,n = 80) and low SpO2(LS, n = 80). Electrocardiographic measurements were performed as previously described.The Tpe (T peak to T end) interval was measured from precordial leads [5].The delta corrected QT interval(QTc) calculated as last electrocardiographic QTc minus first electrocardiographic QTc. Discrepancies between computerized electrocardiographic analysis and the mean of three computer-aided measurements(Adobe Photoshop program-300dpi resolution) by a researcher were resolved by consultation with a second researcher. Using follow-up electrocardiography,according to the direction of QRS axis shift between the first and last electrocardiograms, both groups were divided into two main subgroups:patients with rightward shift (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). 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 Tomographic findings were evaluated in accordance with COVID-19 Reporting and Data System (CO-RADS)classification.CO-RADS scores are as follows: 1 (very low level of suspicion), 2 (low level of suspicion), 3 (equivocal), 4 (high level of suspicion),and 5 (very high level of suspicion)[6].


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date November 5, 2020
Est. primary completion date October 15, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Hospitalized patients with dyspnea and COVID-19 Exclusion Criteria: 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. -

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Electrocardiography ,Tomographic imaging
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.

Locations

Country Name City State
Turkey Sahbender Koç Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Differences in the electrocardiographic rotation Differences in clockwise,counterclockwise,normal transition between the groups. 10-15 days
Primary Differences in the CO-RADS5/CO-RADS1-4 ratio Differences in the CO-RADS5/CO-RADS1-4 ratio between the groups. 10-15 days
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