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

NCT05047835 | Unknown

• 1 other identifier: HE641442
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COVID-19; electrocardiogram; ARDS; Prone position

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Diagnosis

  The first day of admission.

Interventions

electrocardiogram DIAGNOSTIC_TEST

Prone position electrocardiogram

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COVID-19 patients proved by nasal and pharyngeal swab for PCR, who were admitted to the COVID-19 specialized ward and were diagnosed with pulmonary infiltration from a chest x-ray.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen Unversity

Khon Kaen, 40002, Thailand

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Arrhythmias, Cardiac; COVID-19

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Praew Kotruchin, MD, PhD.

CONTACT

+66366869; kpraew@kku.ac.th

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 17, 2021
• Study Start: September 10, 2021
• Primary Completion: April 30, 2023
• Study Completion: December 31, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After the study finished and for 5 years later.
• Access Criteria: For educational or research purposes.

Locations

TH (1)