Protocol summary

Summary
Endotracheal suctioning is common nursing care in intubated patients . nurses commonly instillation normal saline before suctioning procedure . the purpose of instillation N/S is diluting and loosening thick secretions and facilating moblisation and remove secretions.however , its efficacy is unsupported by research based evidence .this study is a randomized , , cross-over , clinical trial , done on 74 intubated patients that recive mechanical ventilation,and their hemodynamic ststus is stable.we lay aside patients had chronic disease and those using cardiac and respiratory medications; using muscle relaxtion medications or change setting ventilator within our study and patients that do not require suctioning after 2 hrs. the purpose of this research is to be determin to be affected with each of the method on patients. in the first cycle of study , patients randomly assigned two group. group A ( suctioning without N/S) group B (suctioning with instilation 5 cc N/S ) , then respiratory and hemodynamic parameters meassure once befoer suctioning and another after suctioning .the next cycle ., rested for 2 hrs, and using cross-over design. two group of patients is interchange.again the whole procedure repeat .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205181174N7
Registration date: 2012-07-21, 1391/04/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-21, 1391/04/31
Registrant information
Name
Atefeh Ghanbari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13780509
Email address
at_ghanbari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University Of Medical Science
Expected recruitment start date
2012-07-05, 1391/04/15
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of endotracheal suctioning with and without normal saline on hemodynamic and respiratory parameters in patients with mechanical ventilation in intensive care unit , rasht,guilan
Public title
The effct of normal saline in endotracheal suctioning on hemodynamic and respiratory parameters.
Purpose
Supportive
Inclusion/Exclusion criteria
Patients with the flowing conditions were included: intubated patients; the ET size is 7-8 fr and to recive volume mechanical ventilation for > 72 hrs and less than for one week; their hemodynamic status is stable ( BP> 90mmHg , urine output of less than 30 ml/h and having balance electrolytes and non disrhythemia. Exclusion certeria: patients had chronic disease such as: cardiac disease, hypertension, COPD and those using cardiac and respiratory medications; using muscle relaxtion medications or change setting ventilator within our study and patients that do not require suctioning after 2 hrs.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

1

Registry name
No
Secondary trial Id
No
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Commitee of Guilan University Of Medical Science
Street address
Guilan University Of Medical Sciences
City
Rasht
Postal code
Approval date
2012-04-17, 1391/01/29
Ethics committee reference number
2910051519

Health conditions studied

1

Description of health condition studied
Patients with impaired respiratory function in ICU
ICD-10 code
J95-99
ICD-10 code description
Other diseases of the respiratory system

Primary outcomes

1

Description
Respiratory parameters include: ETco2
Timepoint
the variable before suctioning and immediately , 15 , 30 , 45 , 30 second and then 1,2,3,4,5 minute aftter suctioning
Method of measurement
Capnograph

2

Description
respiratory rate
Timepoint
the variable before suctioning and 2 and 5 minute after suctioning
Method of measurement
monitor of ventilator

3

Description
mean airway pressure
Timepoint
the variable before suctioning and 2 and 5 minute after suctioning
Method of measurement
monitor of ventilator

4

Description
peak inspiratory pressure
Timepoint
the variable before suctioning and 2 and 5 minute after suctioning
Method of measurement
monitor of ventilator

5

Description
o2 sat
Timepoint
the variable before suctioning and immediately , 15 , 30 , 45 , 30 second and then 1,2,3,4,5 minute aftter suctioning
Method of measurement
pulseoxymeter

Secondary outcomes

1

Description
systolic blood pressure
Timepoint
once before suctioning and another 2and 5 minute afer suctioning
Method of measurement
Monitor

2

Description
diastolic blood pressure
Timepoint
Once before suctioning and another 2and 5 minute after suctioning
Method of measurement
Monitor

3

Description
mean arterial blood pressure
Timepoint
once befor suctioning and another 2and 5 minute afer suctioning
Method of measurement
Monitor

4

Description
pulse rate
Timepoint
once before suctioning and another 2and 5 minute afer suctioning
Method of measurement
Monitor

Intervention groups

1

Description
This study for group A , suctioning is performance once without and once with instillation5 ml normal saline. the blood pressure, respiratory rate, heart rate, mean airway pressure record (prior to suctioning and after 2 and 5 minute after suctioning). then o2 saturation,ETco2 by pulseoxymeter and capnograph(monitor ) record , once before suctioning and another afte suctioningr ( immediately , 15, 30 , 45 second and also 1,2,3,4,5 minute after suctioning ).
Category
Treatment - Other

2

Description
This study for group B , suctioning is performance once with instillation5 ml normal saline and once without . the blood pressure, respiratory rate, heart rate, mean airway pressure record (prior to suctioning and after 2 and 5 minute after suctioning). then o2 saturation,ETco2 by pulseoxymeter and capnograph(monitor ) record , once before suctioning and another afte suctioningr ( immediately , 15, 30 , 45 second and also 1,2,3,4,5 minute after suctioning ).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Educational Medical Centers Of Guilan University Of Medical Science( Razi and Poursina Hospital)
Full name of responsible person
Masoumeh Adib
Street address
Rasht- Shahid Beheshti Boulvar-Shahid Beheshti Collage Of Nursing and Midwifery
City
Rrasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University Of Medical Science
Full name of responsible person
Dr Abdoalrasoul Sobhani
Street address
Rasht - Namjoo Ave -Shahid Siadati Ave-deputy of research Building
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 Science
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 Science
Full name of responsible person
Masoumeh Adib
Position
M.S/Faculty Of Member
Other areas of specialty/work
Street address
Rasht-Shahid Beheshti Boulvar - Shahid Beheshti Collage Of Nursing and Midwifery
City
Rasht
Postal code
41469
Phone
+98 13 1555 5056
Fax
+98 55 50097
Email
AdibMasoomeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University Of Medical Science
Full name of responsible person
Masoumeh Adib
Position
M.S / Faculty Of Member
Other areas of specialty/work
Street address
Rasht- Shahid Beheshti Boulvar- Shahid Beheshti Collage Of Nursing and Midwifery
City
Rasht
Postal code
41469
Phone
+98 13 1555 5056
Fax
+98 55 0097
Email
AdibMasoomeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan university Of Medical Sciences
Full name of responsible person
Masoumeh Adib
Position
M.S /Faculty Of Member
Other areas of specialty/work
Street address
Rasht- Shahid Beheshti Boulvar-Shahid Beheshti Collage Of Nursing and Midwifery
City
Rasht
Postal code
41469
Phone
+98 13 1555 5056
Fax
+98 55 0097
Email
AdibMasoomeh@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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