Objectives; The aim of this study is to evaluate the effects of using Richmond sedation-agitation protocol on the length of hospitalization and mechanical ventilation dependency in ICU patients.
Design; randomized clinical trial study
Setting and conduct; patients hospitalized in hospital affiliated of Ahvaz jundishapur university will be chosen according to inclusion criteria. and then the samples will be allocated randomly into two groups of intervention and control by the stratified blocking method.
Major Inclusion and Exclusion criteria; The patient suffers from the brain trauma and was under the ventilator machine, the lack of family consent for the patient involve in the study.
Intervention; As soon as a patient gets anxious and agitated and every 6 hours by using Richmond sedation-agitation protocol, their level of sedation and agitation in the intervention group will be measured by the researcher and then the final score will be informed to the anesthesia specialist of the ward, he then will order or change the type and dosage of the sedative drugs for the patient based on the score obtained and on the basis of Richmond protocol, if necessary. The control group will not take any intervention and receive routine care of the ward only, Main outcome measures; Length of hospitalization in ICU, mechanical ventilation dependency.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610129469N2
Registration date:2017-01-22, 1395/11/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-22, 1395/11/03
Registrant information
Name
Mohammad Adineh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 1620 0140
Email address
mohadineh@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of using Richmond Sedation-Agitation Scale on the length of stay and mechanical ventilation in ICU patients
Public title
The effects of using Richmond Sedation, Agitation Scale on the length of stay and mechanical ventilation in ICU patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patient with brain truma is intubated and under ventilator; GCS score of ≥ 4; Not using neuromuscular blocker drugs ; The patient's age is between 16 -65 years old; Patient not be hyper active delirium with the physician diagnosis; Patient has no contraindications to the use of midazolam, lorazepam and propofol drugs.
Exclusion criteria: Lack of family consent for the patient participation in the study; The patient transferred to other centers during the study; Patient takes neuromuscular blocker drugs during the study; Patient becomes hyperactive delirium during the study; Making a contraindication for using one of the midazolam, lorazepam and propofol drugs by the patient during the study; Patient agitation is not relieved by Richmond protocol during the study.
Age
From 16 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
103
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ethics Committee, Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences.
Number of days dependence on mechanical ventilation
Method of measurement
Checklist
Intervention groups
1
Description
Intervention group: As soon as a patient gets anxious and agitated and every 6 hours by using Richmond sedation-agitation protocol, their level of sedation and agitation during monitoring under ventilator will be measured by the researcher and then the final score will be informed to the anesthesia specialist of the ward.Then, he will order or change the type and dosage of the sedative drugs for the patient based on the scores , if necessary.
Category
Treatment - Other
2
Description
Control group: non-use of Richmond protocol, receive routine care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomini hospital
Full name of responsible person
Mohammad Adineh
Street address
Naderi st, Emeam hospital, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Behzad Makmalzadeh
Street address
Golestan st, Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Grant name
119
Grant code / Reference number
3849
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Adineh
Position
Instructor of Nursing
Other areas of specialty/work
Street address
Golestan st, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 3554 2036
Fax
Email
mohadineh@gmail.com; adineh-m@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Adineh
Position
Master of critical nursing sciences
Other areas of specialty/work
Street address
Golestan st, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 3554 2036
Fax
Email
mohadineh@gmail.com; adineh-m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Adineh
Position
master of critical nursing
Other areas of specialty/work
Street address
Golestan st, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 3554 2036
Fax
Email
mohadineh@gmail.com; adineh-m@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)