Protocol summary

Study aim
Evaluation of prone positioning in improving the oxygenation of patients with non-intubated & awake ARDS due to COVID-19 pneumonia.
Design
A clinical trial with a control group, with parallel groups, one-sided blind, will be performed on 60 patients
Settings and conduct
the study will be conducted in Rafsanjani Ali Ibn Abitaleb Hospital. patients are randomly divided into two groups A and B. Group A is control and no special intervention is done for them. Group B intervention includes patients who will be lying prone position for hours during the day and night. This change of position will be performed at least 2-3 times a day and will be measured the patient'saturation percentage frequently, ABG, c-reactive protein, lymphocyte and neutrophil count, pulse rate, and respiration per minute, before and after the change of position
Participants/Inclusion and exclusion criteria
inclusion criteria: 18-70 years old, confirmed COVID-19 disease, Saturation of Peripheral Oxygen < 90%, awake, able to prone position
Intervention groups
1.Intervention: patients that expose to prone positioning at certain times of day and night 2. control: Patients who do not lie prone positioning
Main outcome variables
Improve oxygenation of COVID-19 patients without the special facilities

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210724051970N1
Registration date: 2021-09-03, 1400/06/12
Registration timing: prospective

Last update: 2021-09-03, 1400/06/12
Update count: 0
Registration date
2021-09-03, 1400/06/12
Registrant information
Name
Mohammad amin LOTFI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2295 6312
Email address
drlotfimaim@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-21, 1400/06/30
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of prone positioning in improving the oxygenation of patients with non-intubated & awake with lung involvement due to COVID-19 pneumonia
Public title
Evaluation of prone positioning in improving breathing of awake patients with dyspnea due to COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
confirmed diagnosis of COVID-19 requiring non-invasive supplemental oxygen awake and able to do prone positioning
Exclusion criteria:
pregnancy altered consciousness requiring intubation systolic blood pressure < 90 mmHg multi-organ failure
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling and Random allocation: In order to select individuals and assign them to two groups of intervention and comparison, three steps are performed in the form of access sampling, class allocation and simple random allocation, respectively. To do this, first, people with cardiovascular disease referred to Ali Ibn Abitaleb Hospital who meet the inclusion criteria are selected by available sampling. Since in some cases, despite the application of randomization program, there is also the possibility of heterogeneity in some of the initial features in the groups, so using the method Classification on Effective Variables Attempts to eliminate heterogeneity in groups are made before random allocation. In this study, age and sex are very important factors in observing education and improving oxygen delivery, so to ensure the equal distribution of these two variables in the two intervention and comparison groups, based on gender and age of people with four entry criteria, including men And females are more or less equal to 50 years, and then the samples in each class by a simple randomization method Using the Randomization.com website, which is available to researchers for free, they are divided into experimental and control groups. For example, in men over the age of 50, a list of random sequences such as the following sequence is generated and then, based on the number of people entering the study, people are divided into two groups of intervention and comparison.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
No. 10, Azadi Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7716975334
Approval date
2021-06-07, 1400/03/17
Ethics committee reference number
IR.RUMS.REC.1400.059

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Improve oxygenation
Timepoint
ABG measurement at the beginning of the study (before the intervention) and 3 days after it
Method of measurement
Blood draw from radial artery

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Covid-19 patients referred to Ali Ibn Abitaleb Hospital in Rafsanjan, with a change in posture, lie on the abdomen at least two to three times a day (morning, noon and night, at least one hour after a meal for three consecutive days, and The percentage of oxygenation and other respiratory parameters in the form of each patient will be measured immediately before the change of position, 1 hour after the start of the change of position.
Category
Rehabilitation

2

Description
Control group: particular intervention will not be done for them, and receive routine treatment.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Ibn Abitaleb Hospital
Full name of responsible person
Ali Shamsi Zadeh
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0001
Email
drlotfimaim@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
ALi Shamsi zadeh
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
info@rums.ac.ir
Web page address
http://www.rums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad amin Lotfi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Mofatah Blvd, Aliibn abitalib hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0001
Email
drlotfimaim@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad amin Lotfi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Mofatah Blvd, Ali ibn abi talib hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0001
Email
drlotfimaim@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad amin Lotfi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Mofatah Blvd, Ali ibn abi talib hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0001
Email
drlotfimaim@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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