Influence of geographic altitude on the evolution of severe cases of COVID-19 in Ecuador
| ISRCTN | ISRCTN27613785 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27613785 |
| Secondary identifying numbers | No. 015-2020 (Ecuadorian Ministry of Health) |
- Submission date
- 21/06/2021
- Registration date
- 16/08/2021
- Last edited
- 13/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
COVID-19 ranges from mild disease to severe cases of pneumonia, which can be accompanied by a strong inflammatory reaction (acute respiratory distress syndrome or ARDS), multiorgan failure and death. Some factors have been found to influence disease in these patients, including age and the coexistence of other diseases (comorbidities) like obesity, high blood pressure and diabetes. Constant exposure to decreased levels of oxygen (hypoxia) can also lead to a variety of clinical conditions and to physiologic adaptations that allow people living in these environments to reduce their oxygen demand by improving efficiency at a cellular level. During critical illness, it is proposed that natives of high-altitude cities have a higher oxygen utilization efficiency and an advantage over severe patients living at sea level. The aim of this study is to determine if a high geographic altitude affects patients diagnosed with severe cases of COVID-19 requiring oxygen support (mechanical ventilation).
Who can participate?
Patients who are 18 years old or older with a confirmed diagnosis of COVID-19, admitted to the intensive care units between March 2020 and October 2020 in Ecuadorian cities located in a geographical altitude of 2500 m or at sea level, and requiring invasive oxygen support (mechanical ventilation)
What does the study involve?
The study involves the gathering and analysis of data including demographic variables, coexistence of other diseases (comorbidities), symptoms and signs prior to hospital admission, severity scores and initial management. Additionally, laboratory, vital signs (hemodynamic variables), and respiratory variables (mechanical ventilation) will also be collected.
What are the possible benefits and risks of participating?
There will no direct contact with the patients and the information required will be collected using medical registries complying with privacy protocols. All data will be gathered anonymously, and each patient will have a code assigned to them. The data will not be used outside the hospital or research group. Therefore, there are no possible risks to the patients participating in this study. However, the information will become useful and beneficial for treatment and prognosis in future patients.
Where is the study run from?
Hospital de Especialidades Eugenio Espejo (Ecuador)
When is the study starting and how long is it expected to run for?
April 2020 to July 2021
Who is funding the study?
Investigator-initiated and funded
Who is the main contact?
Manuel Jibaja
edison.jibaja@hee.gob.ec
Contact information
Public
Av. Gran Colombia & Yaguachi
Quito
170136
Ecuador
| Phone | +593 (0)999668588 |
|---|---|
| edison.jibaja@hee.gob.ec |
Scientific
Av. Gran Colombia & Yaguachi
Quito
170136
Ecuador
| Phone | +593 (0)999668588 |
|---|---|
| edison.jibaja@hee.gob.ec |
Study information
| Study design | Multicentre longitudinal case-control observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Influence of geographic altitude on the evolution of COVID-19 patients admitted to the intensive care units (ICUs) in Ecuador |
| Study objectives | A geographic altitude of 2500 m or more above sea level affects the evolution of patients diagnosed with COVID-19 admitted to the ICU and requiring mechanical ventilation. |
| Ethics approval(s) | Approved 11/02/2021, Ecuadorian Ministry of Health Ethics Committee (Av. Quitumbe Ñan y Av. Amaru Ñan 170146, Quito, Ecuador; +593 (0)23814400; cnbs@msp.gob.ec); ref: 015-2020 |
| Health condition(s) or problem(s) studied | Severe cases of COVID-19 (SARS-CoV-2 infection) requiring ICU and mechanical ventilation |
| Intervention | Retrospective data collection from the cohort of patients diagnosed with severe COVID-19 between the months of March to July 2021, admitted to Intensive Care Units of hospitals located in Ecuadorian cities with a geographical altitude of 2500 m above sea level and at sea level. Information on demographic variables, comorbidities, symptoms, and signs prior to admission to the ICU, severity indexes, and initial management in the ICU will be collected. Laboratory data, hemodynamic variables, and respiratory variables on mechanical ventilation will also be collected, the latter at admission and after 24 h. Data on withdrawal of mechanical ventilation, specific treatments, complications, and prognosis are collected. |
| Intervention type | Other |
| Primary outcome measure | Mortality (%) of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point |
| Secondary outcome measures | 1. Duration of mechanical ventilation (in days) of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 2. Duration of ICU admission and duration hospitalization (in days) of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 3. PaO2/FiO2 index of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 2. Mortality risk factors of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 3. Comorbidities of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 4. Symptoms and signs prior to admission to the ICU of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 5. Severity indexes of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 6. Initial management of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 7. Laboratory data of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 8. Hemodynamic variables of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 9. Respiratory variables on mechanical ventilation taken on admission and after 24 h in patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 10. Withdrawal of mechanical ventilation from patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 11. Specific treatments received by patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 12. Complications in patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point 13. Prognosis of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point |
| Overall study start date | 01/04/2020 |
| Completion date | 01/07/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | A sample size calculation will not be performed; rather, the maximum possible number of patients meeting the inclusion criteria will be recruited. |
| Key inclusion criteria | 1. Patients (men and women) 18 years old or older 2. Diagnosed with COVID-19 by RT-PCR 3. Admitted to ICUs in Ecuador located in cities with geographic altitude of 2500 ms above sea level and at sea level 4. Need for mechanical ventilation as part of their management |
| Key exclusion criteria | 1. Patients younger than 18 years of age 2. Patients admitted to ICU for a diagnosis other than COVID-19 and also required mechanical ventilation 3. Foreign patients |
| Date of first enrolment | 12/02/2021 |
| Date of final enrolment | 01/05/2021 |
Locations
Countries of recruitment
- Ecuador
Study participating centres
Quito
170136
Ecuador
Quito
170521
Ecuador
Sector Las Tres Marías
Portoviejo
130101
Ecuador
Camino A Rayoloma
Cuenca
010210
Ecuador
Babahoyo
120102
Ecuador
Quito
170103
Ecuador
Ibarra
100104
Ecuador
Sponsor information
Hospital/treatment centre
Av. Gran Colombia & Yaguachi
Quito
170136
Ecuador
| Phone | +593 (0)82230212 |
|---|---|
| jorge.velez@hee.gob.ec | |
| Website | http://hee.gob.ec |
University/education
Diego de Robles s/n & Pampite
Quito
170901
Ecuador
| Phone | +593 (0)82971700 |
|---|---|
| mgrunauer@usfq.edu.ec | |
| Website | https://www.usfq.edu.ec/ |
"ROR" |
https://ror.org/01r2c3v86 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/11/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Iván Sisa(isisa@usfq.edu.ec) Anonymized demographic data and clinical data will become in January 2022, for two years to researchers, by RedCap, for secondary analyses. Informed consent for this study was not obtained. This is a retrospective study of clinical data. Patients/next of keens signed the hospital's consent for treatment. There are no ethical restrictions, as ethical approval was obtained for the study and data is anonymized. |
Editorial Notes
13/08/2021: Trial’s existence confirmed by Ecuadorian Ministry of Health Ethics Committee.
