Evaluation of efficacy and safety of morphine through nebulizer mask in the treatment of acute respiratory distress caused by Covid-19 in adult patients
Design
In this randomized double-blind clinical trial study, patients were randomly divided into two groups of 30 based on a random number table: Morphine with nebulizer mask and Control: Normal saline with nebulizer mask.
Settings and conduct
Patients with acute respiratory distress due to Covid-19 referred to Shahid Madani Hospital in Karaj will be randomly divided into two groups of 30 randomly in one of the intervention / control groups.
Participants/Inclusion and exclusion criteria
This study will be performed in patients with acute respiratory distress due to Covid-19 referred to Shahid Madani Hospital in Karaj in 1400, and Patients with high suspicion / diagnosis of heart failure and unstable angina, severe shock with hemodynamic instability despite increased vascular pressure, severe / undiagnosed pulmonary infection for other reasons (COPD, lung fibrosis, lung cancer, pneumonia Bacterial ...), diagnosis of pulmonary hemorrhage, pregnancy / lactation, other important cause besides ARDS for respiratory failure, need for ECMO during the study, is expected to be transferred to another hospital within 72 hours, known allergies to Morphine, allergy or contraindication to exogenous and endogenous opioids, obesity (BMI> 35 kg / m2) will not be included in the study.
Intervention groups
Intervention group: Patients receive morphine with nebulizer mask immediately after admission to the ward or emergency department + standard treatments based on hospital guideline.
Control group: Patients with normal saline nebulizer mask immediately after admission to the ward or emergency department + standard treatments based on hospital guidelines.
Main outcome variables
Mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211112053042N2
Registration date:2021-12-06, 1400/09/15
Registration timing:prospective
Last update:2021-12-06, 1400/09/15
Update count:0
Registration date
2021-12-06, 1400/09/15
Registrant information
Name
Mohammad Hossein Delshad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3350 2347
Email address
m.delshad@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-20, 1400/09/29
Expected recruitment end date
2022-03-15, 1400/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of morphine through nebulizer mask in the treatment of acute respiratory distress due to Covid-19 in adult patients
Public title
The effect of morphine with nebulizer mask in the treatment of acute respiratory distress in adult patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 80-18 years
Patients with a definitive diagnosis of Covid-19 based on PCR test within 48 hours after hospitalization
Acute moderate respiratory distress syndrome with PaO2 / FiO2 <200 based on Berlin criteria (Force et al., 2012)
Patients with severe dyspnea
Patients in the end-stages of the disease
Lack of proper treatment
Patients with consent to participate in the project
Exclusion criteria:
Patients with high suspicion / diagnosis of heart failure and unstable angina
Existence of severe shock with hemodynamic instability despite increased vascular pressure
Severe / undiagnosed lung infection for other reasons (chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, bacterial pneumonia ...)
Diagnosis of pulmonary hemorrhage
Pregnancy / breastfeeding
An important cause other than acute respiratory distress for respiratory failure
Requires ECMO during the study period
He/she is expected to be transferred to another hospital within 72 hours
Known allergies to morphine
Sensitivity or contraindication to exogenous and endogenous opioids
Obesity (BMI>35 kg/m2 )
Patients with dissatisfaction with participating in the project
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups based on a table of random numbers. Random number table is a set of numbers that are produced without a specific pattern or order and in a completely random manner and become a table. In order to use a random number table, the researcher must first predetermine the table to read the numbers (for example, up, down, left, or right). Individual for the control group). The researcher then touches one of the numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients (intervention or control) will receive encoded sealed envelopes. The coding will be done by one of the project partners and the doctor, the evaluator and the patient will be blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
second floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Golshahr, Karaj.
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2021-10-16, 1400/07/24
Ethics committee reference number
IR.ABZUMS.REC.1400.217
Health conditions studied
1
Description of health condition studied
Acute respiratory distress caused by Covid-19
ICD-10 code
B97.2
ICD-10 code description
Coronavirus as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Mortality rate
Timepoint
During hospitalization
Method of measurement
Based on the patient's record
Secondary outcomes
1
Description
oxygen saturation level
Timepoint
Morphine dose before titration, 2 hours after first titration, 2 hours after second titration, 2 hours after third titration, 2 hours after effective drug titration, 12 hours after effective drug titration, 24 hours after effective drug titration
Method of measurement
Pulse oximetry
Intervention groups
1
Description
Intervention group: Patients receive morphine with a nebulizer mask immediately after admission to the ward or emergency room.
Category
Treatment - Drugs
2
Description
Control group: Patients receive normal saline with a nebulizer mask immediately after admission to the ward or emergency room.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Hospital
Full name of responsible person
Mohammad Hossein Delshad MD.
Street address
Shahid Madani Square, Jahanshahr, Karaj
City
Karaj
Province
Alborz
Postal code
31437 44693
Phone
+98 26 3442 7001
Email
m.delshad@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Hatam Godini P.H.D
Street address
Saffarian alley, 45 meters from Golshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
h.godini@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Hossein Delshad MD.
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 2347
Email
m.delshad@abzums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Hossein Delshad MD.
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 2347
Email
m.delshad@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Hossein Delshad MD.
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 2347
Email
m.delshad@abzums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
Research centers and faculty members
Under which criteria data/document could be used
At the request of the researcher and faculty members
From where data/document is obtainable
Send email to the scientific respondent
What processes are involved for a request to access data/document
Within two months from the time of requesting and sending the email, the documents will be sent to the mentioned people