Objective: to assess the effect of 60 degree head up position on preventing pneumonia in mechanically ventilated intensive care unit patients. Sixty patients aged 20 to 60 years will be randomly allocated to two groups; routine-control (45 degree head up position) and intervention (60 degree head up position). Pneumonia, respiratory rates and volumes will be recorded in a check list. Diagnosis of pneumonia will be confirmed by a specialist in intensive care unit regarding clinical and laboratory criteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106146801N1
Registration date:2011-08-27, 1390/06/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-27, 1390/06/05
Registrant information
Name
Hadi Hassankhani
Name of organization / entity
Tabriz university of medical sciences and health services
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0364
Email address
hassankhanih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
School of nursing and midwifery, Tabriz University of Medical Sciences
Expected recruitment start date
2011-06-03, 1390/03/13
Expected recruitment end date
2011-11-21, 1390/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 60 degree head up position on preventing pneumonia in mechanically ventilated intensive care unit patients
Public title
The effect of 60 degree head up position on preventing pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients between 20 and 60 years of age; Tracheal intubated under mechanical ventilation: MODE = Synchronized Intermittent Mandatory Ventilation (SIMV), Respiratory Rate (RR) = 6-12/min, Positive End-Expiratory Pressure (PEEP) = 2.5-7.5, Tidal Volume (VT) = 6-8 ml / kg, Fio2 = <50; hospitalized for 7 days; ICU admission Glasgow Coma Scale (GCS) <9; gastric feeding through a nasogastric tube, absence of fever and leukocytosis, and any infection (based on blood cultures and tracheal secretions) at the beginning of the study. Exclusion criteria: chest surgery (thoracotomy); Acute Respiratory Distress Syndrome (ARDS); Chronic Obstructive Pulmonary Disease (COPD); obesity, diabetes, cancer, contraindications to the vault open position; patients with neck and spinal trauma.
Age
From 20 years old to 60 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
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
Tabriz University of medical scinces and health services
Street address
Golgasht
City
Tabriz
Postal code
1950/4/5
Approval date
2011-05-22, 1390/03/01
Ethics committee reference number
5/4/1950
Health conditions studied
1
Description of health condition studied
mechanically ventilated intensive care unit patient`s pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified
Primary outcomes
1
Description
pneumonia
Timepoint
1 week
Method of measurement
clinical and lab measurments
Secondary outcomes
empty
Intervention groups
1
Description
head of bed elevation
Category
Prevention
2
Description
no intervention in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz university of medical sciences and health services
Full name of responsible person
hadi hassankhani
Street address
School of Nursing Midwifery, South shariati ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences, School of Nursing Midwifery
Full name of responsible person
Dr Ebrahimi
Street address
Tabriz School of Nursing Midwifery, South Shariati St
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences, School of Nursing Midwifery
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
Sina Hospital
Full name of responsible person
Shahzad Akbarzdeh
Position
Nurse
Other areas of specialty/work
Street address
Sina hospital
City
Tehran
Postal code
1348987431
Phone
+98 912 421 0616
Fax
Email
shd_akbarzade@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tbriz University of Medical Scinces
Full name of responsible person
Dr Hadi Hassankhani
Position
PhD in Nursing educatrion
Other areas of specialty/work
Street address
Tabriz School of Nursing Midwifery, South Shariati St
City
Tabriz
Postal code
Phone
+98 918 318 1267
Fax
+98 41 1479 6969
Email
hassankhanih@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of medical sciences
Full name of responsible person
Hadi Hassankhani
Position
assisstant Professor
Other areas of specialty/work
Street address
Tabriz School of Nursing Midwifery, South Shariati St
City
Tabriz
Postal code
Phone
+98 918 318 1267
Fax
+98 41 1479 6969
Email
hadi1672@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)