Comparison of the effect of continuous positive airway pressure )CPAP) and biphasic Positive Airway Pressure (BiPAP) on hemodynamic parameters in covid-19 patients
Most previous studies on the effects of CPAP and BIPAP masks on hemodynamic status have been performed in patients who usually have relatively stable conditions, and no study has been found comparing the two masks in coronary patients. Evidence suggests that patients Covid-19 sufferers suffer from cardiovascular problems and hemodynamic changes, so in emergencies, the use of respiratory aids with minimal side effects is considered. Because no study was found to compare the hemodynamic effects of CPAP and BIPAP masks on patients with Quid-19, this study was performed.
Design
After approving the proposal and obtaining the permission of the University Ethics Committee, the researcher will go to the hospital and patients with Quid-19 will be selected according to the doctor's diagnosis and laboratory results and based on the inclusion criteria. In this way, the specialist will select patients who need non-invasive ventilation according to the protocol of the Office of Respiratory Failure in Covid-19 of the Ministry of Health. After determining the type of mask, the patient's hemodynamic status (systolic blood pressure, diastolic blood pressure, heart rate) based on the monitor attached to the patient before mask administration, immediately after use and after 1 hour, 6 hours and then daily for up to 3 days at an hour One person will be examined.
Settings and conduct
Teaching hospitals Associated with Gonabad University of Medical Sciences
Participants/Inclusion and exclusion criteria
need for oxygen and candidate for non-invasive respiratory aid (NIV) according to the doctor (need for intubation No)
Exclusion criteria: the need for immediate intubation of the patient
Intervention groups
intervention group with CPAP and intervention group with BiPAP
Main outcome variables
Hemodynamic parameters
General information
Reason for update
Acronym
cbpapc
IRCT registration information
IRCT registration number:IRCT20210424051061N1
Registration date:2021-09-29, 1400/07/07
Registration timing:retrospective
Last update:2021-09-29, 1400/07/07
Update count:0
Registration date
2021-09-29, 1400/07/07
Registrant information
Name
Raziyeh Nikbeen
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3513
Email address
nikbeen.nurse@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of continuous positive airway pressure )CPAP) and biphasic Positive Airway Pressure (BiPAP) on hemodynamic parameters in covid-19 patients
Public title
Effect of continuous and biphasic positive airway pressure in patients with Covid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age 20 -60 y/o
No history of cardiovascular disease such as hypertension, liver, kidney according to self-declaration
Need to prescribe oxygen and candidate for non-invasive respiratory assistance (NIV) according to physician (no need for intubation)
No ban on the use of masks
Definitive diagnosis of coronavirus infection by physician and laboratory results
Exclusion criteria:
Need to intubate the patient immediately
Awareness level based on the Glasgow scale less than 15
Any change in the patient's condition that affects the course of treatment, for example blood pressure below 90 mmhg despite fluid therapy or the use of vasopressors
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, first, individuals are entered into the study in an accessible manner based on inclusion and exclusion criteria, and then using permutation blocks in two groups, CPAP mask and BIPAP mask will be allocated. In this method, if we consider the cpap group A, the bipap group B, the 6 possible states will be in the 4 blocks AABB-BBAA-ABAB-BABA-BAAB-ABBA, which will be assigned a number for each block and each The load will be selected by lot and patients will enter the study, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, health care personnel (physicians, nurses, physiotherapists, etc.) who are responsible for patient care, used the allocation of the device and did not know the purpose of the study.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of gonabad University of Medical Sciences
Street address
9P67+R29,Imam Khomeini street, Gonabad, Razavi Khorasan Province
City
Gonabad
Province
Razavi Khorasan
Postal code
5722381522
Approval date
2021-04-21, 1400/02/01
Ethics committee reference number
IR.GMU.REC.1400.006
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Mean score of hemodynamic parameters
Timepoint
Before the mask is prescribed, it will be examined by a person immediately after use and after 1 hour, 6 hours and then daily for up to 3 days at a specific time.
Method of measurement
Patient-connected monitoring device
Secondary outcomes
1
Description
Mean oxygen saturation, mean blood pressure, mean pulse rate
Timepoint
Based on the monitor attached to the patient before the mask is administered, immediately after use and after 1 hour, 6 hours and then daily for up to 3 days at a specific time will be examined by one person.
Method of measurement
Patient-connected monitoring device
Intervention groups
1
Description
Intervention group: In this research, the CPAP device of Saadat and venet manufacturers is used. Using an air pump, the CPAP device transmits airflow to the patient at a pressure set by the mask. The device settings are adjusted by a physician or specialist based on the information contained in the sleep test. These settings include parameters such as the number of apneas; Adjustable pressure range: 20 - 4 cm water; Pressure adjustment: 3 - 0 cm of water; Adjustable initial pressure by the patient; Device settings with buttons; LED lights on the device; Storing, calculating and retrieving information is like the average total treatment hours.
Category
Treatment - Drugs
2
Description
Intervention group: In this research, the BIPAP device of Fisher and Resmed manufacturers is used, which includes a humidifier chamber-hose and mask whose settings include IPAP-EPAP (IPAP applies maximum pressure at the time of inhalation and EPAP minimum pressure at the time of Exhale).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Teaching hospitals related toGonabad Medical Sciences Hospital
Full name of responsible person
Dr. Kokab Basiri Moghaddam
Street address
9P67+R29,Imam Khomeini street, Gonabad, Razavi Khorasan Province
City
Gonabad
Province
Razavi Khorasan
Postal code
5722381522
Phone
+98 51 5722 3551
Email
k.basiri@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Kokab Basiri Moghaddam
Street address
9P67+R29,Imam Khomeini street, Gonabad, Razavi Khorasan Province
City
Gonabad
Province
Razavi Khorasan
Postal code
5722381522
Phone
+98 51 5722 3513
Email
k.basiri@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
2
Sponsor
Name of organization / entity
Vice Chancellor for Research, Gonabad University of Medical Sciences
Full name of responsible person
Dr. Kokab Basiri Moghaddam
Street address
9P67+R29, Imam Khomeini street,Gonabad, Razavi Khorasan Province
City
Gonabad
Province
Razavi Khorasan
Postal code
5722381522
Phone
+98 51 5722 3513
Email
k.basiri@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Kokab Basiri Moghaddam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
9P67+R29,Imam Khomeini street, Gonabad, Razavi Khorasan Province
City
Gonabad
Province
Razavi Khorasan
Postal code
5722351322
Phone
+98 51 5722 3513
Email
k.basiri@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Kokab Basiri Moghaddam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
9P67+R29, Gonabad, Imam Khomeini street, Razavi Khorasan Province
City
Gonabad
Province
Razavi Khorasan
Postal code
5722351322
Phone
+98 51 5722 3513
Email
k.basiri@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Kokab Basiri Moghaddam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
9P67+R29,Imam Khomeini street, Gonabad, Razavi Khorasan Province
City
Gonabad
Province
Razavi Khorasan
Postal code
5722381522
Phone
+98 51 5722 3815
Email
k.basiri@gmu.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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
After completing the plan
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
For research
From where data/document is obtainable
Researcher email address
What processes are involved for a request to access data/document