Determination and comparison of respiratory indicators of patients with respiratory failure under ventilator before and after intervention in two groups of control and intervention. Determining and comparing the duration of mechanical ventilation of patients with respiratory failure under ventilator before and after the intervention in two groups of control and intervention.
Design
Randomized Control Trial(RCT) with control and parallel group
Settings and conduct
The research environment of ICU ward of Imam Khomeini Hospital is affiliated with Tehran University of Medical Sciences. Respiratory index of patients in the intervention group will be measured first and at the end of each day Other indicators, such as the duration of mechanical ventilation and the length of hospital stay in the ICU, will be collected in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria for this study included 48 hours after intubation and mechanical ventilation, age over 18 years and under 65 years, patients with RASS greater than -3 and less than 2, stable hemodynamic conditions with minimal dose of supportive drugs, Patients with PEEP <8, <60 FiO2, 89 <Spo2% and respiration rate of more than 12 and less than 30.
Intervention groups
The intervention designed for this study is a standard 4-level protocol. Measures taken at this level include changing the position every 2 hours, inactive movement of the joint area 3 times a day, and the patient should be placed in a fully sitting position for at least 2 times for 20 minutes. All second-level measures are also performed at levels 3 and 4.
Main outcome variables
Respiratory index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161124031068N4
Registration date:2020-05-21, 1399/03/01
Registration timing:prospective
Last update:2020-05-21, 1399/03/01
Update count:0
Registration date
2020-05-21, 1399/03/01
Registrant information
Name
Maryam Esmaeili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4402
Email address
esmaeili_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-19, 1399/03/30
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of early mobilization on clinical index in patients with respiratory failure undergoing mechanical ventilation in intensive care units
Public title
Effect of early mobilization on clinical index in respiratory failure
Psychosomatic disorder
Any mobility disfunction
Acute cerebral strock
BMI>40
Femour fracture
After CPR
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into control and intervention groups based on the random allocation of double blocking. To do this, the 4 blocks will be selected so that they will belong to the letter A intervention group and the letter B control group. 6 probable states are written on separate cards and one number (from one to six) will be assigned to each card, then the numbers will be written on paper and randomly removed.Until the expected number of samples is completed. In this study, online randomization service (https://www.sealedenvelope.com/simple-randomiser/v1/lists) will be used for randomized block allocation.Allocation concealment will be done using closed envelopes, so that one letter is placed inside each envelope in the specified order, and then the envelope lid will be closed and provided to the 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 in Research, School of Nursing and Midwifery, and Faculty of Rehabilitation, Tehran
Street address
Nosrat St.,Tohid Sq.,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.TUMS.FNM.REC.1399.007
Health conditions studied
1
Description of health condition studied
Respiratory Failure
ICD-10 code
J96.9
ICD-10 code description
Respiratory failure, unspecified
Primary outcomes
1
Description
Respiratory index
Timepoint
Before the start, the end of the first day, the end of the second day, the end of the third day
Method of measurement
Arterial blood gas and monitoring system
Secondary outcomes
1
Description
Duration of hospital stay in ICU and duration of mechanical ventilation
Timepoint
Mechanical ventilation weaning and discharge from ICU
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group:The intervention designed for this study is a standard 4-level protocol. In the first level, the range of motion of the joints is performed on non-conscious patients and five times on each joint. At the second level, the physiotherapy protocol begins.The patient must answer three of the commands so that the researcher realizes that she/he is ready to enter the next stage.Open your eyes, look at me, open your mouth and stick out your tongue, raise and lower your head, raise your eyebrows when you hear the number 5. If the patient responds to three of the researcher's five requests, his or her condition is appropriate for initiating physiotherapy. When the patient finds sufficient strength and alertness to participate in occupational therapy, he or she will be moved toward two active recipient approaches or active range of motion. They move from level 2 to 4.Measures taken at this level include changing the position every 2 hours, inactive movement of the joint area 3 times a day, and the patient should be placed in a fully sitting position for at least 2 times for 20 minutes.All second-level measures are also performed at levels 3 and 4. The upgrade from level 2 to 3 and from 3 to 4 depends on the score that the patient receives from the MRC criterion in terms of muscular strength in one attempt.A score of 3 out of 5 on the biceps is required to enter level 3 and a score of 3 out of 5 on the quadriceps is required to enter level 4. As the patient progresses, activities should focus on a variety of functions such as sitting on the edge of the bed, getting out of bed, sitting in a balanced position, and pre-starting exercises such as weight transfer on the legs or walking and moving. The implementation of this protocol in the form of interdisciplinary and team work with the cooperation of the members of this team will include a researcher, physiotherapist, physician in charge of ICU and assistant to the ward assistant.
Category
Rehabilitation
2
Description
Control group: In this study, the control group will receive the usual care of the ward. The usual care of the section under study in this study is to change the position once or twice in each shift.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomaini hospital
Full name of responsible person
Maryam Esmaeili
Street address
Nosrat St., Tohid Sq., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
fnm@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohamad Ali Sahraeian
Street address
sixth floor, Deputy of Research and Technology, Central University Organization, corner of Quds Street, Keshavarz Boulevard,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Esmaeili
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Central Organization, Tehran University of Medical Sciences, Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
esmaeili_m@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Esmaeili
Position
Associate Professor, Tehran university of medical sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Central Organization, Tehran University of Medical Sciences, Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
esmaeili_m@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Esmaeili
Position
Associate professor, Tehran university of medical sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Central Organization, Tehran University of Medical Sciences, Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
esmaeili_m@tums.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data will be shared.
When the data will become available and for how long
starting 6 months after publication.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There is no limitation.
From where data/document is obtainable
Email address.
What processes are involved for a request to access data/document
Documents will be sent via email after the work is completed and 6 months after the article is published.