Improved oxygenation of patients with severe COVID-19
Design
The study was designed as a single-blind clinical trial. The study population will be patients undergoing ventilation in the ICU with positive PCR for coronavirus. The sample size was calculated in each group of 15 people. Assigning samples to two groups will also be simple random.
Settings and conduct
Patients are divided into two groups based on simple random distribution. The first group is given 3 ml of adrenaline (one in 1000) plus 2 ml of normal saline. The second group is given 5 ml of normal saline. Patients under ventilation in the ICU of Ayatollah Mousavi Hospital in Zanjan, Iran will enroll in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 y; PCR positive for COVID-19; Dyspnea, cough, and fever at the time of admission; under invasive mechanical ventilation; Pulmonary involvement in lung imaging.
Exclusion criteria: history of cardiovascular diseases; history of brain diseases; history of pulmonary diseases; pregnancy
Intervention groups
3 cc of adrenaline (1 in 1000) plus 2 cc of normal saline is prescribed for case group.
Main outcome variables
Oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210613051560N1
Registration date:2021-12-20, 1400/09/29
Registration timing:prospective
Last update:2021-12-20, 1400/09/29
Update count:0
Registration date
2021-12-20, 1400/09/29
Registrant information
Name
Masoud Asadi-Khiavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3342 0651
Email address
masadi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of endotracheal epinephrine effect on Increasing Oxygen Saturation level in COVID-19 patients with severe pulmonary involvement
Public title
Endotracheal epinephrine effect on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
PCR positive for COVID-19
Tachypnea, cough and fever at the time of admission
Under aggressive mechanical ventilation
Pulmonary involvement in lung imaging
Exclusion criteria:
History of cardiovascular diseases
History of brain diseases
History of pulmonary diseases
Pregnancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will perform on eligible patients using intratracheal epinephrine or intratracheal normal saline in every other manner. From the beginning, it is agreed to assign individual numbers to the intervention group and even numbers to the control group. Then extract the random sample size from the table of random numbers and assign each number (odd number to the first patient and even number to the second patient) to each patient. In other words, the first patient to qualify for the study will enroll in the intervention group and be treated using intratracheal epinephrine, and the second patient to qualify will enroll in the control group and be treated using intratracheal normal saline. That is, randomization is done by marking the even and odd numbers assigned to each case and is not considered as a sequential (non-random) style. This process will continue until the groups are completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are unaware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Dr.Sobouti Blvd., Zanjan,Iran
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2021-10-27, 1400/08/05
Ethics committee reference number
IR.ZUMS.REC.1400.342
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
J12.81
ICD-10 code description
Pneumonia due to SARS-associated coronavirus
Primary outcomes
1
Description
Oxygen saturation
Timepoint
Oxygen saturation is measured before intervention and 5, 10, 30 and 60 minutes after intervention.
Method of measurement
Using pulse oximetry and ABG
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with severe COVID-19 under mechanical ventilation who receive intratracheal epinephrine. At the beginning of enrollment of patients in this group, for each patient in this group, 3 ml of adrenaline one in 1000 (manufactured by Iran Hormone Pharmaceutical Company) plus 2 ml of normal saline 0.9% (manufactured by Shahid Ghazi Pharmaceutical Company) is prescribed in a nebulized form. And the consequences mentioned in the presented plan are measured in the relevant schedule.
Category
Treatment - Drugs
2
Description
Control group: Patients with severe Covid-19 who receive intratracheal normal saline.