Protocol summary

Study aim
Determine the effect of combination changes of catheter size and negative suction pressure on hemodynamic and respiratory parameters in patients undergoing mechanical ventilation.
Design
Clinical trial without control group
Settings and conduct
Study will be done in the Shahid Beheshti and Imam Sajjad Hospitals in Yasuj. 1 minute before and after suction Oxygen will be 100% received and before connecting the catheter to the suction tube the negative suction pressure will be adjusted by blocking the end of the suction tube The suctioning catheter when struck, pull 1 cm back , suction will be performed 2 times for 10 seconds Between these ,the patient will be connected to the ventilator for 30 seconds
Participants/Inclusion and exclusion criteria
Inclusion criteria: Minimum age of 18 and up to 65 years, connecting to a fixed volume ventilator , at least 24 hours before intervention in the intensive care unit Hospitalized and and has a size of 7.5 in the trachea tube , Stable hemodynamic status , Have a score of -2 to -5 based on the Richmond scale. Exclusion criteria: Having respiratory illnesses like Asthma, emphysema, COPD and ARDS diagnosed by physician ,the use of positive inotropic drugs, such as dopamine and dobutamine 3- Severe cardiovascular and pulmonary failure , high intracranial pressure, score (-1 to 4+) based on Richmond's scale, blood coagulation disorder and thrombocytopenia
Intervention groups
35 patients in a single-group will be suctioned 4 times.initially with a catheter of 10 and a negative pressure of 100, second time a catheter of 10 and a negative pressure of 150 , third time a catheter of 12 and a negative pressure of 100 and fourth time the catheter size 12 and the negative pressure 150
Main outcome variables
Hemodynamic parameters and respiratory parameters will be recorded before, immediately, 10 and 20 minutes after suction.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190120042436N1
Registration date: 2019-03-06, 1397/12/15
Registration timing: prospective

Last update: 2019-03-06, 1397/12/15
Update count: 0
Registration date
2019-03-06, 1397/12/15
Registrant information
Name
Mohsen Salari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 4115
Email address
salarimo@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-09, 1397/12/18
Expected recruitment end date
2019-06-08, 1398/03/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effect of combinational changes of catheter size and its related suction negative pressure on hemodynamic and respiratory parameters of patients undergoing mechanical ventilation
Public title
Effect of endotracheal suctioning on hemodynamic and respiratory parameters of patients undergoing mechanical ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age 18 and maximum 65 years Having an endotracheal tube and connecting to fixed volume ventilator (SIMV-A / C) The patient should be admitted at least 24 hours before the intervention in the intensive care unit and under mechanical ventilation and has an endotracheal tube with diameter of 7.5. Stable hemodynamic status( Medium arterial pressure between 60-110 mm-Hg -Hypertension is more than 90 and less than 140- And diastolic pressure of less than 100 mm Hg-Heart rate less than 100 and more than 60 beats per minute -And oxygen saturation of arterial blood more than 90%) Have a score of -2 to -5 based on the Richmond Agitation Sedation Scale
Exclusion criteria:
Having respiratory illnesses like asthma, emphysema,COPD, ARDS diagnosed by expert physician The use of positive inotropic drugs, such as dopamine and dobutamine Severe cardiovascular and pulmonary failure High intracranial pressure Having a score (-1 to 4+) based on Richmond's Scale Having blood coagulation disorder and thrombocytopenia
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 35
More than 1 sample in each individual
Number of samples in each individual: 4
Each patient will undergo a tracheal suctioning for 4 times.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
35 patients with single-group mechanical ventilation each will be suctioned in 4 times with different catheter sizes and negative pressure.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of yasuj University of Medical Sciences
Street address
Assistance of Research and Technology of the University , Yasouj University of Medical Sciences , Shahid Motahari Blvd., Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2019-02-16, 1397/11/27
Ethics committee reference number
IR.YUMS.REC.1397.143

Health conditions studied

1

Description of health condition studied
Coma, unspecified
ICD-10 code
R40.20
ICD-10 code description
Unspecified coma

Primary outcomes

1

Description
Hemodynamic parameters
Timepoint
Immediately before - immediately - 10 and 20 minutes after the trachea suction
Method of measurement
Central Monitor device

2

Description
Respiratory parameters
Timepoint
Immediately before, immediately, 10 and 20 minutes after the trachea suction
Method of measurement
Ventilator machine and computational formula

Secondary outcomes

1

Description
Heart rate
Timepoint
Immediately before , immediately , 10 and 20 minutes after the trachea suction
Method of measurement
central Monitor device

2

Description
فشار خون سیستول
Timepoint
Immediately before - immediately - 10 and 20 minutes after the trachea suction
Method of measurement
Central Monitor device

3

Description
Diastolic blood pressure
Timepoint
Immediately before - immediately - 10 and 20 minutes after the trachea suction
Method of measurement
Central Monitor device

4

Description
Median arterial pressure
Timepoint
Immediately before - immediately - 10 and 20 minutes after the trachea suction
Method of measurement
Central Monitor device

5

Description
Arterial oxygen saturation
Timepoint
Immediately before - immediately - 10 and 20 minutes after the trachea suction
Method of measurement
Central Monitor device

6

Description
Airway resistance
Timepoint
Immediately before ,immediately ,10 and 20 minutes after the trachea suction
Method of measurement
Computational formula

7

Description
Dynamic compilation
Timepoint
Immediately before ,immediately ,10 and 20 minutes after the trachea suction
Method of measurement
Computational formula

8

Description
Maximum airway pressure
Timepoint
Immediately before ,immediately ,10 and 20 minutes after the trachea suction
Method of measurement
Ventilator Bennet 840

9

Description
Plato Press
Timepoint
Immediately before , immediately , 10 and 20 minutes after the trachea suction
Method of measurement
Ventilator Bennet 840

10

Description
Expiratory tidal volume
Timepoint
Immediately before ,immediately , 10 and 20 minutes after the trachea suction
Method of measurement
Ventilator Bennet 840

Intervention groups

1

Description
Intervention group: Intervention on 35 patients by single-group method Which will have a tracheal tube under mechanical ventilation Each patient is subjected to suction for 4 times, initially with a catheter of 10 and a negative pressure of 100 For the second time, a catheter of 10 and a negative pressure of 150 For the third time, a catheter of 12 and a negative pressure of 100 and for the fourth time the catheter size 12 and the negative pressure 150 are used and the interval between two suction tracheal suction doses for each patient is at least 2 hours.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Sajjad Hospital - Shahid Beheshti Hospital
Full name of responsible person
Mohsen Salari
Street address
nursing school , Dr. Shahid Jalil street, Yasouj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5140
Email
salarimo@yums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Vice-chancellor of Research, Dr. Hossein Mari Oryad
Street address
Vice chancellor of Research and Technology, Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
oryadhsn@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Mohsen Salari
Position
Ph.D. Pediatric Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Zaynab nursing school . Dr. shajid jalil Street, Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 33235140
Email
salarimo@yums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Mohsen Salari
Position
Ph.D in Pediatric Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Zaynab Nursing School. Dr. shajid jalil Street, Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5140
Email
salarimo@yums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Maryam Jafari
Position
Master's candidate in medical- surgical Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazrat Zaynab Nursing School . Dr. shajid jalil Street, Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5140
Email
maryam.jafari@yums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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