This study aimed to determine the effect of controlled sedation based Richmond- tool on clinical outcomes in mechanically ventilated patients admitted to intensive care in the hospital in Rasht in 2017. This study is a randomized and single center. Inclusion criteria include patients undergoing coronary artery bypass graft that receiving mechanical ventilation in ICU; patients are receiving the sedation drugs. Patients ages 30 to 70 years old, after the operation requires mechanical ventilation for less than 24 hours and the number one to four arterial grafts without the need Endarterectomy; lack of hearing and vision problems or difficulty in understanding the language of Persian, exclusion criteria included Patients with postoperative cardiac and respiratory arrest and need to re-operation due to abnormal bleeding.
The number of samples in each group computed 40 patients in that randomized block design are divided the blocks A and B. the Richmond tool used for evaluation the sedation level of patients in the intervention group. but the control group received routine. COPT tool measuring pain in both groups. Two groups are compared duration of mechanical ventilation and the hemodynamic parameters
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050517693N2
Registration date:2017-05-24, 1396/03/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-24, 1396/03/03
Registrant information
Name
Mohammad Reza Yeganeh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 5056
Email address
yeganeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of controlled sedation based Richmond tool on clinical outcomes in mechanically ventilated patients admitted to intensive care units
Public title
The effect sedation level on weaning of mechanical ventilation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing coronary artery bypass graft (CABG); From ages 30 to 70 years old; Need for mechanical ventilation for less than 24 hours after the operation; The number of one to four arterial grafts without the need to Endarectomy; Lack of hearing and vision problems or difficulty in understanding the language of Persian
Exclusion criteria: Cardiac and respiratory arrest after surgery; The need for re-operation due to abnormal bleeding
Age
From 17 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethic Committee of Guilan University of Medical Sciences, Vice chancellor for research
Street address
Opposite bank sepah, Boulevard Martyr Beheshti western, Rasht
City
Rasht
Postal code
41938-93345
Approval date
2017-04-29, 1396/02/09
Ethics committee reference number
IR.GUMS.REC.1396.37
Health conditions studied
1
Description of health condition studied
mechanical ventilation duration
ICD-10 code
T81.8, Z51
ICD-10 code description
Other complications of procedures, not elsewhere classified , Other specified medical care
Primary outcomes
1
Description
sedation level
Timepoint
intervention time
Method of measurement
richmond scale
2
Description
pain
Timepoint
intervention time
Method of measurement
COPT scale
3
Description
mechanical ventilation duration
Timepoint
intervention time
Method of measurement
hour
4
Description
the amount of using of sedative
Timepoint
intervention time
Method of measurement
mg,mcigram/h , based on a sedation
Secondary outcomes
1
Description
Length of stay in Hospital
Timepoint
discharge or dead
Method of measurement
day
2
Description
Length of stay in ICU
Timepoint
discharge of ICU
Method of measurement
hour
3
Description
median arterial pressure
Timepoint
intervention time
Method of measurement
mmHG with manitor
4
Description
body mass index
Timepoint
before intervention
Method of measurement
weight by meters squared
5
Description
pulse pressure
Timepoint
intervention time
Method of measurement
mmHG with manitor, difference between SBPand DBP
6
Description
pulse rate
Timepoint
intervention time
Method of measurement
bpm with monitor
7
Description
o2 saturation
Timepoint
intervention time
Method of measurement
percentage
Intervention groups
1
Description
Intervention group: Mechanically ventilated patients receive
the amount of sedative based on Richmond scale measured every hour the sedation level
Category
Other
2
Description
Control group: Mechanically ventilated patients receive routinely the amount of sedative without used agitation sedation scales
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Heart Dr Heshmat
Full name of responsible person
Mohammad Reza Yeganeh
Street address
15 Azar St, next to Management and PlaningOrganization
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of medical Sciences, Vice chancellor for research
Full name of responsible person
Mohammad Reza Yeganeh
Street address
Opposite bank sepah, Boulevard Martyr Beheshti western, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of medical Sciences, Vice chancellor for research
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
Guilan University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Mohammad Reza Yeganeh
Position
Msc, Nursing
Other areas of specialty/work
Street address
Opposite bank sepah, Boulevard Martyr Beheshti western, Rasht
City
Rasht
Postal code
4193893345
Phone
+98 13 3336 2772
Fax
+98 13 3336 2842
Email
yeganeh@gums.ac.ir
Web page address
www.gums.ac.ir/nmr
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan Uiversity of Medical Sciences
Full name of responsible person
Mohammad Reza Yeganeh
Position
Msc. Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, St Student, High way Martyr Beheshti, Rasht
City
Rasht
Postal code
41466939841
Phone
+98 13 3355 5058
Fax
+98 13 3355 0097
Email
yeganeh@gums.ac.ir
Web page address
www.gums.ac.ir/nmr
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Reza Yeganeh
Position
Msc.Nursing
Other areas of specialty/work
Street address
ST Student, High way Martyr Beheshti , Rasht
City
Rasht
Postal code
4146939841
Phone
+98 13 3355 5058
Fax
+98 13 3355 0097
Email
yeganeh@gums.ac.ir
Web page address
www.gums.ac.ir/nmr
Sharing plan
Deidentified Individual Participant Data Set (IPD)