Protocol summary

Summary
Objective: to determine the impact of closed endotracheal suction system on the values of arterial blood gases of patients undergoing open heart surgery in Imam Ali hospital, kermanshah. Study design: randomized. Study population: Patients undergoing open heart surgery and admitted to the intensive care unit at Imam Ali hospital. Major inclusion criteria: having an endotracheal tube, being under mechanical ventilation, having acceptable clinical and Para clinical criteria such as sufficient tissue perfusion and urinary output. Major exclusion criteria: having paranchymal lung diseases, congestive heart failure, chronic smoker, congenital cyanotic diseases, right to left shunt, and renal failure. Sample Size: 42 patients. Intervention: using closed and open endotracheal suction systems. Time of intervention: firstly, closed or open endotracheal suction randomly will be performed for each patient and for the second time vice versa. In order to remove the effects of previous suction on the results of the next one, the interval between the two suctions, is to at least 60 minutes. Before the tracheal suction an arterial blood sample will be taken for having the base value. Arterial blood samples will be taken 1, 5 , and 15 minutes after each suction in the both methods. Primary outcomes: abg results

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201009134736N1
Registration date: 2010-12-18, 1389/09/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-12-18, 1389/09/27
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research & technology, Kermanshah university of medical sciences
Expected recruitment start date
2010-11-06, 1389/08/15
Expected recruitment end date
2010-12-21, 1389/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a closed-endotracheal suction system on the ABGs of patients undergoing open heart surgery and admitted in the intensive care unit of Imam Ali hospital
Public title
Effect of closed syction on arterial blood gases
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: 1. Having tracheal tube and being under mechanical ventilation 2. Having acceptable clinical and paraclinical criteria such as adequate tissue perfusion and urinary output 3. Having coronary artery bypass graft surgery 4. Chest tube drainages lower than 100 ml/hr 5. Temperature between 35 to 38.5 ° C 6. Having normal Hg, Hct, and electrolytes (Na and K) 7. Having arterial blood gases (PaO2, PaCO2) in the acceptable ranges Exclusion Critera: 1. Patients with paranchymal lung diseases such as COPD, emphysema, and asthma 2. Patients with chest disorders such as kyphosis 3. Patients who are chronic smokers 4 .patients with lung contusion 5. Patients who have treated with Bronchodilators and Mocolytic drugs suck as Salbutamol and N-Acetylcystein before admission to hospital 6. patients with congenital cyanotic diseases and right to left shunt 7. Patients with congestive heart failure 8. Patients who suffered cardiac arrest due to hypoxia 9. Patients with heart valves diseases 10. Patients with Intra aortic balloon pump 11. Patients who need frequent suctioning 12. Patients who are suffering from renal failure
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of kermanshah university of medical sciences
Street address
Shahid beheshty Blv.
City
Kermanshah
Postal code
Approval date
2010-06-28, 1389/04/07
Ethics committee reference number
204/420/7/پ

Health conditions studied

1

Description of health condition studied
Arterial Blood Gases
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Arterial blood gases
Timepoint
Pre-suction and 1, 5 and 15 minutes after suction
Method of measurement
Laboratory methods

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group a open suctioning system will be performed with the disconnection of the patient from the ventilator and the introduction of the suction catheter into the endotracheal tube.
Category
Prevention

2

Description
In the control group a closed suctioning system included in the ventilatory circuit, allowing to introduce the suction catheter into the airways without disconnecting the patient from the ventilator.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali hospital
Full name of responsible person
Dr Gholamreza Morady
Street address
Sepah pasdaran sq. shahid beheshty bld.
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Dr Farid Najafy
Street address
Kermanshah university of medical sciences, sepah pasdaran sq. shahid beheshty bld.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah school of nursing and midwifery
Full name of responsible person
Alireza Khatony
Position
PhD. dean of faculty
Other areas of specialty/work
Street address
Doolat abbad, ashayer bld.
City
Kermanshah
Postal code
6719851351
Phone
+98 83 1827 9394
Fax
+98 83 1827 9394
Email
Akhatony@gmail.com
Web page address
http://nursing-school.kums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah school of nursing and midwifery
Full name of responsible person
Alireza Khatony
Position
Phd- dean of faculty
Other areas of specialty/work
Street address
Dolaat abad, ashayer bld
City
Kermanshah
Postal code
6719851351
Phone
+98 83 1827 9394
Fax
+98 83 1827 9394
Email
akhatony@gmail.com
Web page address
http://nursing-school.kums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah school of nursing and midwifery
Full name of responsible person
Alireza khatony
Position
PhD-faculty member, dean of faculty
Other areas of specialty/work
Street address
Doolat aba'd, ashayer bld.
City
Kermanshah
Postal code
6719851351
Phone
+98 83 1827 9394
Fax
+98 83 1827 9394
Email
akhatony@gmail.com
Web page address
http://nursing-school.kums.ac.ir/

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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