Comparing the effect of head of bed elevation 30 and 45 degree on incidence of ventilator associated pneumonia in patients admitted to Intensive Care Units.
1). Main aim of current study is investigating effects of head of bed elevation 30, 45 degree on incidence of ventilator associated pneumonia among admitted patients in ICU. 2) Design study as randomized clinical trial with control group. 3) Method: 120 patients with max 8 hours intubation in ICU as randomized within two groups as control and intervention groups. 4) All participants should intubated now or at least they should intubated up to 8 hours before and they should not have pneumonia or pressure ulcers. 5). Interference: intervention group should be under 30 or 45 degree within 3 days and they should receive all routine cares. Control group were not under any angles and only receive all routine cares . 6). The primary outcome variable is ventilator associated pneumonia and secondary outcome variable is pressure ulcers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120225345N1
Registration date:2016-04-29, 1395/02/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-29, 1395/02/10
Registrant information
Name
Leila Kalhor
Name of organization / entity
Iran Univercity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 4686 6474
Email address
kalhor.l@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Iran University of Medical Science
Expected recruitment start date
2016-04-13, 1395/01/25
Expected recruitment end date
2016-10-17, 1395/07/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of head of bed elevation 30 and 45 degree on incidence of ventilator associated pneumonia in patients admitted to Intensive Care Units.
Public title
Comparing the effect of head of bed elevation 30 and 45 degree on incidence of Ventilator Associated Pneumonia in patients admitted to Intensive Care Unites. unites.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria’s: Age more than 18 years old, Lack of ventilator associated Pneumonia, Hospitalized patients in ICU with mechanical ventilation up to max 8 hours after admission and intubation of patients, Lack of pressure ulcers,
Lack of spine injuries and or unstable pelvic fractures.
Exclusion criteria’s :
Patient death, Patients who were in semi recumbent position less than 6 hours within 24 hours, Patients who have pressure ulcers on 45 degree, Separating patients from mechanical ventilation or transport to other units before 72 hours.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Iran Univercity of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-11-29, 1394/09/08
Ethics committee reference number
IR.IUMS.REC.1394.9311449007
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J18
ICD-10 code description
Pneumonia, organism unspecified
Primary outcomes
1
Description
Ventilator Associated Pneumonia
Timepoint
3 days after intervention
Method of measurement
CPIS scale
Secondary outcomes
1
Description
pressure ulcer
Timepoint
3 days after intervention
Method of measurement
Braden Scale
Intervention groups
1
Description
In intervention group, patients positioned 30,45 degree for 3 days. Head of bed elevation measure with goniometer.
Category
Prevention
2
Description
In control group, patients not position in degree and only recived routin care.