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Comparison the effect of distilled water and normal saline instillation during endotracheal suctioning on hemodynamic parameters and ventilator associated pneumonia among patients under mechanical ventilation

Protocol summary

Study aim
Comparison the effect of distilled water and normal saline instillation during endotracheal suctioning on hemodynamic parameters and ventilator associated pneumonia among patients under mechanical ventilation
Design
A parallel single blinded randomized controlled clinical trial
Settings and conduct
Selecting of 60 intubated patients admitted to the intensive care unit of Imam Jafar Sadegh Hospital affiliated to Alborz University of Medical Sciences, randomly, and instillation 3 to 5 cc of either distilled water or normal saline in the trachea before endotracheal suctioning for 5 continuous days by nurse in the intervention and control group, respectively, and after that, obtaining culture from trachea and send it to the laboratory to determine the ventilator-associated pneumonia by the laboratory staffs blinded to the allocation groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Negative culture of the trachea; Systolic blood pressure more than 90 mmHg; Normal level of electrolytes; Without cardiac arrhythmia; Urinary output more than 30 cc per hour; Without asthma, chronic obstructive pulmonary disease, or lung infections. Exclusion criteria: With previous asthma, chronic obstructive pulmonary disease, or lung infections.
Intervention groups
Intervention group: Instillation of 3 to 5 cc of distilled water (Samen company, Iran) in the trachea before endotracheal suctioning for 5 continuous days by nurse Control group: Instillation of 3 to 5 cc of normal saline (Samen company, Iran) in the trachea before endotracheal suctioning for 5 continuous days by nurse
Main outcome variables
Ventilator associated pneumonia; Hemodynamic parameters such as blood pressure, heart rate, respiratory rate, and peripheral blood oxygen saturation (SpO2)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161124031068N2
Registration date: 2018-10-20, 1397/07/28
Registration timing: retrospective

Last update: 2018-10-20, 1397/07/28
Update count: 0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Maryam Esmaeili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4402
Email address
esmaeili_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
2018-07-23, 1397/05/01
Scientific title
Comparison the effect of distilled water and normal saline instillation during endotracheal suctioning on hemodynamic parameters and ventilator associated pneumonia among patients under mechanical ventilation
Public title
Comparison the effect of distilled water and normal saline on hemodynamic parameters and ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Negative culture of the trachea at the beginning of intubation Systolic blood pressure more than 90 mmHg without administration of inotropic drugs Normal level of electrolytes Without cardiac arrhythmia Urinary output more than 30 cc per hour Without asthma Without chronic obstructive pulmonary disease Without lung infections
Exclusion criteria:
With previous asthma With previous chronic obstructive pulmonary disease With previous lung infections
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block balanced randomization method will be used. Randomization sequence will be generated by free website available from: www.randomization.com. In order to determine the randomization sequence in this website, 4 subjects in each block will be considered. Thus, by considering letter A for control group and letter B for intervention group, randomization sequence will be generated for 21 blocks. For random allocation concealment, cards containing blocks will be inserted in standard envelopes. In order to determine the allocation group, one envelope will be taken randomly by the researcher after shuffling.
Blinding (investigator's opinion)
Single blinded
Blinding description
All cultures related to the patients will be sent to laboratory. However, laboratory staffs prepared the culture would not be aware of the allocation groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 123, School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town,
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4263

Health conditions studied

1

Description of health condition studied
Ventilator associated pneumonia (VAP)
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia

Primary outcomes

1

Description
Ventilatore associated pneumonia
Timepoint
Before intervention and 5 days after intervention
Method of measurement
Endoteracheal culture

Secondary outcomes

1

Description
Blood pressure
Timepoint
Before and 5 minutes after endotracheal suctioning
Method of measurement
Vital-signs monitoring device

2

Description
Heart rate
Timepoint
Before and 5 minutes after endotracheal suctioning
Method of measurement
Vital-signs monitoring device

3

Description
Respiratory rate
Timepoint
Before and 5 minutes after endotracheal suctioning
Method of measurement
Vital-signs monitoring device

4

Description
Peripheral blood oxygen saturation (SpO2)
Timepoint
Before and 5 minutes after endotracheal suctioning
Method of measurement
pulse oximeter

Intervention groups

1

Description
Intervention group: Instillation of 3 to 5 cc of distilled water (Samen company, Iran) in the trachea before endotracheal suctioning for 5 continuous days by nurse
Category
Prevention

2

Description
Control group: Instillation of 3 to 5 cc of normal saline (Samen company, Iran) in the trachea before endotracheal suctioning for 5 continuous days by nurse
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Jafar Sadegh Hospital
Full name of responsible person
Maryam Esmaeili
Street address
Imam Jafar Sadegh Hospital, Parastar Ave, Hashtgerd, Alborze state
City
Hashtgerd
Province
Alborz
Postal code
3361659943
Phone
+98 26 4421 0917
Email
EmamJafarsadegh@abzums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadali Sahraian
Street address
Research deputy of Tehran University of Medical Sciences, No. 21, Qods St., Keshavarz Blvd., Tehran Town,
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8163 3698
Email
msahrai@tuma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Esmaeili
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 123, School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733117
Phone
+98 21 6692 7171
Email
Esmaeiliem@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Esmaeili
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 123, School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733117
Phone
+98 21 6692 7171
Email
Esmaeiliem@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Esmaiili
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 123, School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Esmaeiliem@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After making data unrecognizable, all data will be shared.
When the data will become available and for how long
Starting in January 2020
To whom data/document is available
It will be available for researchers working in academic institutions.
Under which criteria data/document could be used
For people that have academic education and these data can be useful for their research.
From where data/document is obtainable
Maryam Shafei; maryam_nursing@yahoo.com
What processes are involved for a request to access data/document
email to "maryam_nursing@yahoo.com" and comment that why he/she wants to access to these data
Comments
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