Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients

Cardiovascular Diseases Clinical Trial

Official title:

Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients: A Prospective Study in Specialized COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05047835
• Other study ID #: HE641442
• Status: Recruiting
• Start date: September 10, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Khon Kaen University
• Contact: Praew Kotruchin, MD, PhD.
• Phone: +66366869
• Email: kpraew[@]kku.ac.th
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prolonged prone position ventilation reduces the 30-day mortality in acute respiratory distress syndrome (ARDS) and in COVID-19 infection. A large number of patients with COVID-19 suffered from new-onset cardiac disease, therefore, ECG is crucial. However, there is limited data on the effects of prone position on the ECG in COVID-19 patients.

Description:

Prolonged prone position ventilation reduces the 30-day mortality in acute respiratory distress syndrome (ARDS) and in COVID-19 infection. The evidence showed that a large number of patients with COVID-19 suffered from new-onset cardiac disease due to inflammatory processes or cytokine storm, therefore, ECG is crucial for making the diagnosis including arrhythmias and myocardial infarction. However, there is limited data on the effects of prone position on the ECG in COVID-19 patients. Therefore, we aimed to identify differences of electrical parameters between prone position and standard ECG including the difference in amplitude and duration of P, QRS, PR interval, QT interval, ST-segment between both positions (supine and prone). Furthermore, we aimed to compare clinical diagnosis from EKG between prone position and standard ECG by the cardiologists.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• COVID-19 patients who were admitted to the COVID-19 specialized ward
• Age 18 -80 years old
• Suffered from pulmonary infiltration

Exclusion Criteria:

• Intubated patients
• Cardiac arrest patients whether at presentation or during the study period
• ECG cannot be performed due to anatomical defects or superficial skin problems

Related Conditions & MeSH terms

• Acute Lung Injury
• Arrhythmias, Cardiac
• Cardiovascular Diseases
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Diagnostic Test:
• electrocardiogram
Prone position electrocardiogram

Locations

Country	Name	City	State
Thailand	Khon Kaen Unversity	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of P wave amplitude	The relative changes in P-wave amplitudes with different body positions were evaluated by dividing the 12-lead ECG into subregions (I, aVL: lateral limb leads; II, III, and aVF: inferior leads; V1 to V3: anterior precordial leads; V4 to V6: lateral precordial leads).	The first day of admission
Primary	The change of QRS-complex amplitude	The relative changes in QRS-complex amplitudes with different body positions were evaluated by dividing the 12-lead ECG into subregions (I, aVL: lateral limb leads; II, III, and aVF: inferior leads; V1 to V3: anterior precordial leads; V4 to V6: lateral precordial leads).	The first day of admission
Primary	The change of T wave amplitude	The relative changes in T wave amplitudes with different body positions were evaluated by dividing the 12-lead ECG into subregions (I, aVL: lateral limb leads; II, III, and aVF: inferior leads; V1 to V3: anterior precordial leads; V4 to V6: lateral precordial leads).	The first day of admission
Secondary	Diagnosis	The EKG diagnosis from prone position and standard supine position which perform in the same time, in the same patient, by a cardiologist will be compared.	The first day of admission.