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

Sponsor
Khon Kaen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05047835
Collaborator
(none)
60
1
11.7
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: electrocardiogram

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients: A Prospective Study in Specialized COVID-19
Actual Study Start Date :
Sep 10, 2021
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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).

  3. 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).

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Khon Kaen Unversity Khon Kaen Thailand 40002

Sponsors and Collaborators

  • Khon Kaen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Praew Kotruchin, Associate professor, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT05047835
Other Study ID Numbers:
  • HE641442
First Posted:
Sep 17, 2021
Last Update Posted:
Sep 23, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Praew Kotruchin, Associate professor, Khon Kaen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 23, 2021