Clinical Trial Protocol

Iranian Registry of Clinical Trials

05 Oct 2023

The Effect of two Different Size of Suction Catheter on The Hemodynamic

Parameters, Pain And Secretion Removal of Patient in The ICU

Protocol summary Registrant information

Name
Summary Akvan Paymard
This Quasi-Experimental Study On Patients in Intensive Name of organization / entity
Care Beheshti Hospital of Yasouj With Less BThan Eight Yazd University of Medical Sciences
Level Of Consciousness That Has Conditions Such As an Country
Oral Endotracheal Tube and Connected To a Ventilator Iran (Islamic Republic of)
With Volume Mode, The Minimum Age of Eighteen Years Phone
and Up Sixty Years;Systolic Blood Pressure More Than +98 35 3824 1751
Email address
One Hundred or Less Than a Hundred and Forty ‫ ؛‬Heart
paymard@ssu.ac.ir
Rate Less Than a Hundred Beats Per Minute and Blood
Oxygen Saturation More Than Ninety Percent،Will Be Recruitment status
Done.Thirty of These Patients That Their Inclusion Recruitment complete
Criteria Are Selected.The Exclusion Criteria of This Study Funding source
Include Lack of Willingness of The Family to Participate in Yazd University Of Medical Siences
The Study, Requires Less Than Three Times in Each
Stage Suction, Diseases, Blood Coagulation Disorders, Expected recruitment start date
Paralysis for Patients‫ ؛‬Receiving Narcotic Drugs and 2015-09-23, 1394/07/01
Muscle Relaxants.This study Will Be Conducted as a Expected recruitment end date
Crossover Design, Each Day Randomly Twelve or 2015-12-01, 1394/09/10
Fourteen Patients Undergoing Tracheal Suction Catheter Actual recruitment start date
Placed With Suction Three Episodes and Each Time IsTen empty
Seconds.And Finally Heart Rate, Blood Pressure, Blood Actual recruitment end date
Oxygen Saturation,Pain and Secretion Removal Weight empty
Before, During and After the Suction is Measured and Trial completion date
Compared. empty

Scientific title
General information The Effect of two Different Size of Suction Catheter on
The Hemodynamic Parameters, Pain And Secretion
Acronym Removal of Patient in The ICU
IRCT registration information
IRCT registration number: IRCT2015100724410N1 Public title
Registration date: 2015-12-02, 1394/09/11 The Effect Of Catheter Size on Hemodynamic Parameters
Registration timing: retrospective Purpose
Supportive
Inclusion/Exclusion criteria
Last update: (Inclusion Criteria:Being Admitted to Hospital Intensive
Update count: 0 Care Units‫ ؛‬an Oral Endotracheal Tube and Connected to
Registration date a Ventilator With Volume Mode‫ ؛‬The Minimum Age of 18
2015-12-02, 1394/09/11 Years and Maximum 60 Years‫ ؛‬Systolic Blood Pressure

1
 Greater Than 100 and Less Than 140‫ ؛‬Less Heart Rate of Primary outcomes
100 Beats Per Minute‫ ؛‬Oxygen Saturation Greater Than
90%) (Exclusion Criteria:Need to Suction More Than 3
Times‫ ؛‬Diseases and Blood Coagulation Disorders‫؛‬ 1
Thrombocytopenia‫؛‬Not Paralyzed Patient‫ ؛‬Underlying Description
Respiratory Disease‫ ؛‬Particularly Narcotic Drugs and Heart Rate
Muscle Relaxants) Timepoint
Age 5 Minutes Before The Suction،First Suction For 10
From 18 years old to 60 years old Seconds، Two Seconds Suctioning For10 Seconds، Third
Gender Suction For10 seconds، 5 Minutes After Suctioning، 20
Both Minutes After Suctioning
Method of measurement
Phase Monitoring
N/A
Groups that have been masked
No information 2
Sample size Description
Target sample size: 37 O2 Saturation
Randomization (investigator's opinion) Timepoint
N/A 5 Minutes Before The Suction،First Suction For 10
Randomization description Seconds، Two Seconds Suctioning For10 Seconds، Third
Blinding (investigator's opinion) Suction For10 seconds، 5 Minutes After Suctioning، 20
Double blinded Minutes After Suctioning
Blinding description Method of measurement
Placebo Monitoring
Not used
Assignment
3
Crossover
Other design features Description
Blood Pressure
Timepoint
Secondary Ids 5 Minutes Before The Suction، 5 Minutes After Suctioning،
empty 20 Minutes After Suctioning
Method of measurement
Monitoring
Ethics committees
4
1
Description
Ethics committee
Pain
Name of ethics committee
Timepoint
shahid saddoghi yazd university of medical of siences
First Suction For 10 Seconds، Two Seconds Suctioning
Street address
For10 Seconds، Third Suction For10 seconds
In Front of the Infertility Center, Safaieh street,Bu Ali
Method of measurement
Boulevard
Observation By Cpot Tools
City
Yazd
Postal code 5
Approval date Description
2015-09-27, 1394/07/05 Secretion Removal
Ethics committee reference number Timepoint
ir.ssu.rec.1394.86 After Suctioning
Method of measurement
Health conditions studied Digital Balance

1 Secondary outcomes
Description of health condition studied
Coma 1
ICD-10 code Description
R40.2 Level Of Consciousness
ICD-10 code description Timepoint
Coma, unspecified Before Of Intervention

2
Method of measurement Country of origin
Glasscow Coma Scale Type of organization providing the funding
empty
Intervention groups
Person responsible for general inquiries
1 Contact
Description Name of organization / entity
Endotracheal Suction With 12 French Catheter Yazd School of Nursing and Midwifery
Category Full name of responsible person
Diagnosis Akvan Paymard
Position
Msn in Critical Care Nursing
2 Other areas of specialty/work
Description Street address
Endotracheal Suction With 14 French Catheter Yazd School of Nursing and Midwifery‫؛‬In Front of the
Category Infertility Center‫؛‬Safaieh street ‫؛‬Bu Ali Boulevard
Diagnosis City
Yazd
Postal code
Recruitment centers
Phone
+98 35 3824 1751
1 Fax
Recruitment center Email
Name of recruitment center akvan_paimard9@yahoo.com, paymard@ssu.ac.ir
Shahid Beheshti Hospital of Yasuj Web page address
Full name of responsible person www.ssu.ac.ir
Akvan Paymard
Street address Person responsible for scientific
Shahid Beshti Hospital,Yasuj
inquiries
City
Yasuj Contact
Name of organization / entity
Sponsors / Funding sources Shahid Sadoghi Yazd University Of Medical Sciences
Full name of responsible person
Dr Mostafa Javadi
1 Position
Sponsor Phd In Nursing
Name of organization / entity Other areas of specialty/work
School of Nursing and Midwifery Yazd Street address
Full name of responsible person School of Nursing and Midwifery Yazd‫؛‬In Front of the
Dr Mostafa Javadi Infertility Center‫؛‬Safaieh street ‫ ؛‬Bu Ali Boulevard
Street address City
Iin Front of the Infertility Center,Safaieh street , Bu Ali Yazd
Boulevard Postal code
City Phone
Yazd +98 35 3824 1751
Grant name Fax
Grant code / Reference number Email
Is the source of funding the same sponsor akvan_paimard9@yahoo.com, Javadi@ssu.ac.ir
organization/entity? Web page address
Yes www.ssu.ac.ir
Title of funding source
School of Nursing and Midwifery Yazd Person responsible for updating data
Proportion provided by this source
100 Contact
Public or private sector Name of organization / entity
empty Yazd University of Medical Sciences, School of
Domestic or foreign origin Nursing and Midwifery Yazd
empty Full name of responsible person
Category of foreign source of funding Akvan Paymard
empty Position

3
 Msn In Critical Care Nursing Sharing plan
Other areas of specialty/work
Street address Deidentified Individual Participant Data Set (IPD)
empty
Iin Front of the Infertility Center,Safaieh street , Bu Ali
Study Protocol
Boulevard empty
City Statistical Analysis Plan
Yazd empty
Postal code Informed Consent Form
Phone empty
Clinical Study Report
+98 35 3824 1751
empty
Fax
Analytic Code
Email empty
akvan_paimard9@yahoo.com Data Dictionary
Web page address empty