Investigation of the effects of prone position on respiratory status, hemodynamics, hospital stay and transfer to intensive care unit in patients with Covid-19: A randomized controlled clinical trial
Investigation of the effects of prone position on respiratory status, hemodynamic, hospital stay and transfer to intensive care unit in patients with Covid-19
Design
The clinical trial is a randomized controlled trial with parallel groups in 74 patients
Settings and conduct
Intervention group: For the first time, the participant is placed in a prone position for 90 minutes. After evaluating the initial outcome, participants are asked to be in the prone position between 20 or 30 minutes of tolerance every three hours during hospitalization, so that the total time in the prone position is between 6 or 8 in 24 hours, and then the secondary outcome will be evaluated.
Control group: For the first time, participants are asked to be in the supine position for 90 minutes. After evaluating the primary outcomes, the patient is asked to rest in his or her normal position, and then the secondary outcomes are evaluated.
Participants/Inclusion and exclusion criteria
All patients with COVID-19 based on the standard diagnostic test and the presence of at least one respiratory symptom include the study and in the following cases will exclude from the study:
Patient intolerance
Severe hemodynamic and respiratory changes greater than 20% of baseline
Severe cough
Nausea and vomiting during the position
Intervention groups
Intervention group or prone position group
Control group or common position group
Main outcome variables
Hemodynamic status and respiratory status include o2 saturation, respiration rate, shortness of breath, mean arterial blood pressure, and pulse rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160126026217N4
Registration date:2020-06-08, 1399/03/19
Registration timing:prospective
Last update:2020-06-08, 1399/03/19
Update count:0
Registration date
2020-06-08, 1399/03/19
Registrant information
Name
Sajad Yarahmadi
Name of organization / entity
Iran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 5655
Email address
yarahmadi.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effects of prone position on respiratory status, hemodynamics, hospital stay and transfer to intensive care unit in patients with Covid-19: A randomized controlled clinical trial
Public title
Investigation of the effects of prone position on cardiac and respiratory status in patients with Coronavirus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with COVID-19 based on standard diagnosed test and had at least one respiratory symptom
Age between 18 and 65 years
Willing to participate in the study
Exclusion criteria:
Do not use mechanical ventilation devices
Absence of respiratory diseases such as asthma and COPD
Not suffering from hypertension
No history of heart failure
No history of orthopedic and spinal problems
No history of neurological diseases
Lack of anemia
Lack of treatment-induced pulmonary complications such as barometer and chest tube installation
No history of thoracic surgery in the last 6 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
The patients by block randomization assigned in intervention and control groups. Classification is done using a random number table. Classes by age(below 50 years/ older 50 years) and gender (male/female). It should be noted that the volume of each block is 4 cases, thus creating 6 different combinations of 4 blocks and randomly selecting the blocks. Blocking and allocation sequences for concealment will be done by the non-involved researcher.
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 Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, Anooshirvan Rezaei Square
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.LUMS.REC.1399.059
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
RA01.0
ICD-10 code description
Covid-19
Primary outcomes
1
Description
Mean blood pressure
Timepoint
At 0, 30, 60, 90 and 120 minutes after the first intervention
Method of measurement
Digital sphygmomanometer
2
Description
Heart rate
Timepoint
At 0, 30, 60, 90 and 120 minutes after the first intervention
Method of measurement
Pulse oximeter device
3
Description
Oxygen saturation
Timepoint
At 0, 30, 60, 90 and 120 minutes after the first intervention
Method of measurement
Pulse oximeter device
4
Description
Respiratory rate
Timepoint
At 0, 30, 60, 90 and 120 minutes after the first intervention
Method of measurement
Count the number of breaths per minute
5
Description
Breath shortness
Timepoint
At 0, 30, 60, 90 and 120 minutes after the first intervention
Method of measurement
Visual analog scale for breath shortness
Secondary outcomes
1
Description
Hospital stay
Timepoint
Patient discharge time
Method of measurement
Count the number of days a patient is hospitalized
2
Description
Percentage of patients transferred to the intensive care unit
Timepoint
At the end of the study
Method of measurement
Percentage of the number of patients who will be transferred to the intensive care unit
3
Description
Mortality rate of patients
Timepoint
At the end of the study
Method of measurement
The number of patients who die by the end of the study
Intervention groups
1
Description
Intervention group: In this group, participants will be in the prone position for 90 minutes for the first time. After evaluating the initial outcomes, the participant will be asked to be in the prone position for 6 to 8 hours until the clearance time, and then the secondary outcomes will be evaluated.
Category
Treatment - Other
2
Description
Control group: In this group, participants will be in their usual position for 90 minutes for the first time, after evaluating the initial outcomes, the participant will be asked to be in his usual positions until the time of discharge, and then the secondary outcomes will be evaluated.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Ashayer hospital
Full name of responsible person
Sajad Yarahmadi
Street address
Shohadaye Ashayer hospital, Enghlab Blvd
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3323 6401
Fax
+98 66 3322 0105
Email
s.yarahmadi000@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ebrahim Falahi
Street address
Lorestan university medical sciences, km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village