COVID-19 Acute Respiratory Distress SyndromeNCT05047835
Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients
An observational study of COVID-19 Acute Respiratory Distress Syndrome and Cardiovascular Diseases, run by Khon Kaen University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome, Cardiovascular Diseases, Arrhythmias, Cardiac
- What is being tested?
- electrocardiogram
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 10 Sep 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- COVID-19 patients who were admitted to the COVID-19 specialized ward
- Age 18 -80 years old
- Suffered from pulmonary infiltration
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Khon Kaen Unversity
Khon Kaen, 40002
Jiranan Thedmee, BSc, jirathe@kku.ac.th
About this study
Official title: Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients: A Prospective Study in Specialized COVID-19
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.
Read the 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.
- Conditions
- COVID-19 Acute Respiratory Distress Syndrome, Cardiovascular Diseases, Arrhythmias, Cardiac
- Being tested
- electrocardiogram
- Keywords
- COVID-19, electrocardiogram, ARDS, Prone position
- Medical subject headings
- Cardiovascular Diseases, Arrhythmias, Cardiac, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrocardiogramDiagnostic test
Prone position electrocardiogram
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: The first day of admission
Secondary outcomes (1)
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.
Measured: The first day of admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start10 Sep 2021
- Primary completion30 Apr 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Praew Kotruchin, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047835
- Sponsor's protocol ID
- HE641442
- Status last verified
- Oct 2023
- First submitted
- 16 Sep 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For educational or research purposes, data can be provided by contacting PI or correspondent author.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients: A Prospective Study in Specialized COVID-19
- ClinicalTrials.gov ID
- NCT05047835
- Acronym / sponsor ID
- HE641442
- Conditions
- COVID-19 Acute Respiratory Distress Syndrome, Cardiovascular Diseases, Arrhythmias, Cardiac
- Keywords
- COVID-19, electrocardiogram, ARDS, Prone position
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- COVID-19 patients who were admitted to the COVID-19 specialized ward
- Age 18 -80 years old
- Suffered from pulmonary infiltration
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrocardiogramProne position electrocardiogram | Diagnostic test | – |
Primary outcome
The change of P wave amplitude
Time frame: 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
Time frame: 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).
The change of T wave amplitude
Time frame: 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).
1 secondary outcome
Diagnosis
Time frame: The first day of admission.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Yes. For educational or research purposes, data can be provided by contacting PI or correspondent author.
Related trials for COVID-19 Acute Respiratory Distress Syndrome
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
Active, not recruitingPhase 1/2
Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia
COVID-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome
Active, not recruitingPhase 2
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Acute Respiratory Distress Syndrome, Viral or Bacterial Infections
Active, not recruitingObservational study
Post Acute Sequelae of COVID-19
Covid19, Sars-CoV-2 Infection
RecruitingObservational study
BALance: ARDS Deconvolution by Bronchoalveolar Lavage Multiomics and Radiomics
ARDS (Acute Respiratory Distress Syndrome)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Acute Respiratory Distress Syndrome and Cardiovascular Diseases, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Praew Kotruchin, MD, PhD. (+66366869, kpraew@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of P wave amplitude (time frame: The first day of admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.