Protocol summary

Summary
The aim of the study: The application of progressive change position program in lung health in patients undergoing mechanical ventilation. Design of study: Progressive change position program is gradually putting the patient in the chair position that 3 times a day and in three different shifts, for 4 days, will be done and Includes the following steps: The head of the bed at an 45 degrees and the foot of the bed an -75 degrees for 15 minutes; The head of the bed at an 60 degrees and the foot of the bed an -75 degrees for 15 minutes; The head of the bed at an 75 degrees and the foot of the bed an -75 degrees for 30 minutes. In this study, drug or chemical composition will not be used. In this study of the ergonomics rule is used to determine the angles of the bed. Healthy lungs in this study is the respiratory index in the range of natural and not infection to mechanical ventilation pneumonia. Sampling method: Completely randomized block design Study population: All newly admitted patients under mechanical ventilation tube in the ICU. Inclusion criteria: Age between 18 to 65 years; Having oral endotracheal tube; Connected to a mechanical ventilator; Lack of previous pneumonia by chest radiography; Lack of Immunosuppressive diseases; Lack of Immunosuppressive drug; Lack of damage to the spine and being permitted to impose conditions according to intensive care specialist. Exclusion criteria: The patient died during the study; Leaving the endotracheal tube at the time of the study; The separation of mechanical ventilation during the study; The risk of pneumonia after 24 hours according to intensive care specialist. Sample: 30 patients in each group Method: First newly admitted patients under mechanical ventilation tube in the ICU are evaluated for inclusion criteria and the patients with inclusion criteria are selected and investigated for mechanical ventilation pneumonia by intensive care specialist. The patients with pneumonia are removed and then the sampling, the samples in the intervention group or control will be done. Then in the intervention group, 24 hours after admission, the progressive change position program until obtain exclusion criteria by the researcher and trained nurses will be done. Progressive change position program are as follows: The head of the bed at an 45 degrees and the foot of the bed an -75 degrees for 15 minutes The head of the bed at an 60 degrees and the foot of the bed an -75 degrees for 15 minutes The head of the bed at an 75 degrees and the foot of the bed an -75 degrees for 30 minutes In both groups, routine care will be alike. Respiratory parameters in intervention group (Respiratory rate, Tidal volume, Minute ventilation and Arterial oxygen saturation) before the program, half an hour after starting the program, immediately after and one hour after the end of the program will be measured and recorded. Respiratory parameters in control group (Respiratory rate, Tidal volume, Minute ventilation and Arterial oxygen saturation) at the same intervals as the intervention group will be recorded. 48 and 96 hours after study (Two times during the study) patients will be examined by colleague physician based on set criteria from pneumonia associated with mechanical ventilation, and cases of pneumonia associated with mechanical ventilation will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110237874N1
Registration date: 2011-12-18, 1390/09/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-18, 1390/09/27
Registrant information
Name
Narges Baghcheghi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1251 9636
Email address
baghcheghi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2011-11-01, 1390/08/10
Expected recruitment end date
2011-12-31, 1390/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of progressive change position program on lung health in patients undergoing mechanical ventilation
Public title
Effect of progressive change position program on lung health in patients undergoing mechanical ventilation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 to 65 years; Having oral endotracheal tube; Connected to a mechanical ventilator; Lack of previous pneumonia by chest radiography; Lack of Immunosuppressive diseases; Lack of Immunosuppressive drug; Lack of damage to the spine and being permitted to impose conditions according to intensive care specialist. Exclusion criteria: The patient died during the study; Leaving the endotracheal tube at the time of the study; The separation of mechanical ventilation during the study; The risk of pneumonia after 24 hours according to intensive care specialist.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical scinces, Shahid Fahmideh St, Hamadan, Iran
City
Hamadan
Postal code
6516859593
Approval date
2011-10-26, 1390/08/04
Ethics committee reference number
16/35/9/2657/پ/د

Health conditions studied

1

Description of health condition studied
Mechanical ventilation pneumonia
ICD-10 code
(J44.0)
ICD-10 code description
lower respiratory infection

Primary outcomes

1

Description
Respiratory rate
Timepoint
Before starting the program, Half an hour after starting the program, Immediately after the end of program, An hour after the end of program
Method of measurement
Observation of values ​​of respiratory rate in monitor ventilator

2

Description
Tidal volume
Timepoint
Before starting the program, Half an hour after starting the program, Immediately after the end of program, An hour after the end of program
Method of measurement
Observation of values ​​of respiratory rate in monitor ventilator

3

Description
Oxygen saturation of arterial blood
Timepoint
Before starting the program, Half an hour after starting the program, Immediately after the end of program, An hour after the end of program
Method of measurement
Observation of values ​​of arterial blood oxygen in pulse oximetry

Secondary outcomes

empty

Intervention groups

1

Description
The Intervention group: Implementing of progressive change position program Progressive change position program is gradually putting the patient in the chair position that 3 times a day and in three different shifts, for 4 days, will be done and Includes the following steps: The head of the bed at an 45 degrees and the foot of the bed an -75 degrees for 15 minutes; The head of the bed at an 60 degrees and the foot of the bed an -75 degrees for 15 minutes; The head of the bed at an 75 degrees and the foot of the bed an -75 degrees for 30 minutes. In this study, the ergonomics rule is used to determine the angles of the bed. In this study, drug or chemical composition will not be used.
Category
Prevention

2

Description
In control group, do not any intervention. In this group, as intervention group, routine work is performed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamadan Besat hospital
Full name of responsible person
Narges Baghcheghi
Street address
ICU, Besat hospital, Shahid Motahari Blv, Resalat Sq, Hamadan, Iran
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Ali Ghaleiha
Street address
Hamadan University of Medical scinces, Shahid Fahmideh St, Hamadan, Iran
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Narges Baghcheghi
Position
Mcs student in critical care nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Scinces, Shahid Fahmideh St, Hamadan, Iran
City
Hamadan
Postal code
6516859593
Phone
+98 81 1251 9636
Fax
+98 81 1251 9636
Email
baghcheghi@umsha.ac.ir; baghcheghinarges@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Narges Baghcheghi
Position
Msc student in critical care nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Scinces, Shahid Fahmideh St, Hamadan, Iran
City
Hamadan
Postal code
6516859593
Phone
+98 81 1251 9636
Fax
+98 81 1251 9636
Email
baghcheghi@umsha.ac.ir; baghcheghinarges@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Narges Baghcheghi
Position
Msc student in critical care nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Scinces, Shahid Fahmideh St, Hamadan, Iran
City
Hamadan
Postal code
6516859593
Phone
+98 81 1251 9636
Fax
+98 81 1251 9636
Email
baghcheghi@umsha.ac.ir;baghcheghinarges@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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