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

Recruiting

• Conditions: COVID-19 Acute Respiratory Distress Syndrome; Cardiovascular Diseases; Arrhythmias, Cardiac

• Registration Number: NCT05047835
• Lead Sponsor: Khon Kaen University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-09-10
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-17
• Primary Completion: 2023-04-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of T wave amplitude	The first day of admission	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 change of P wave amplitude	The first day of admission	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 change of QRS-complex amplitude	The first day of admission	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).

Secondary Outcome Measures

Name	Time	Method
Diagnosis	The first day of admission.	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.

Trial Locations

Locations (1)

Khon Kaen Unversity; 🇹🇭 Khon Kaen, Thailand