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Comparison the effect of open and closed endotracheal suctioning systems on cardiopulmonary parameters of ventilated patients in general ICU at Hamadan's Besat Hospital 1390.

Protocol summary

Summary
Objective: to determine the impact of open and closed endotracheal suction system on the cardiopulmonary parameters of ventilated patients in general ICU at Hamadan's Besat Hospital 1390. Study design: randomized. Study population: patients admitted to the intensive care unit at Hamadan's Besat Hospital. Major inclusion criteria: having an endotracheal tube, being under mechanical ventilation,age between 18 to 65 years, having acceptable hemodynamic parameters. Major exclusion criteria: Become unstable hemodynamic parameters of patients during the study, require suctioning at the time of wash out, need to perform medical intervention during the study, fighting with ventilator. Sample Size: 42 patients. Intervention: using closed and open endotracheal suction systems on any of the samples. 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 30 minutes. Design variables will be taken before suctioning, 1, 5, 10 and 15 minutes after endotracheal suctioning with both open and closed suction system. Primary outcomes: changes in cardiopulmonary parameters.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106066714N1
Registration date: 2011-06-21, 1390/03/31
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-06-21, 1390/03/31
Registrant information
Name
Ali Afshari
Name of organization / entity
Hamadan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1251 9636
Email address
afshari@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research & technology, Hamadan university of medical sciences
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2011-09-06, 1390/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of open and closed endotracheal suctioning systems on cardiopulmonary parameters of ventilated patients in general ICU at Hamadan's Besat Hospital 1390.
Public title
Effect of closed suction on cardiopulmonary parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Having tracheal tube and being under mechanical ventilation; Not with chronic obstructive pulmonary diseases; Do not use of dopamine,dobutamin and nitroglycerin; Being stable hemodynamic parameters; age between 18 to 65 years; Being in supine position; The patient was paralyze and ventilated with CMV mode. Exclusion Criteria: require suctioning at the time of wash out; Become unstable hemodynamic parameters of patients during the study; Need for necessary diagnostic or therapeutic intervention on a patient while doing research; fighting with ventilator(due to Disappear Paralyze or Being conscious).
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 38
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 Hamadan university of medical sciences
Street address
Hamadan university of medical sciences, Shahid Fahmideh st, Hamadan
City
Hamadan
Postal code
Approval date
2011-05-30, 1390/03/09
Ethics committee reference number
16/35/9/790/پ/د

Health conditions studied

1

Description of health condition studied
comatose patient
ICD-10 code
R40.2
ICD-10 code description
Coma, unspecified

Primary outcomes

1

Description
Blood pressure
Timepoint
Pre-suction and 1, 5, 10 and 15 minutes after suction
Method of measurement
Cuff pressure gauge attached to the patient bedside monitor

2

Description
heart rate
Timepoint
Pre-suction and 1, 5, 10 and 15 minutes after suction
Method of measurement
patient's Bedside monitor

3

Description
heart rates pattern
Timepoint
Pre-suction and 1, 5, 10 and 15 minutes after suction
Method of measurement
patient's Bedside monitor

4

Description
SPO2
Timepoint
Pre-suction and 1, 5, 10 and 15 minutes after suction
Method of measurement
patient's Bedside monitor

Secondary outcomes

empty

Intervention groups

1

Description
In this study, the suction is done on the samples. In this way, the patient separated from the ventilator and suction catheter placed inside the tracheal tube and suction is done.
Category
Prevention

2

Description
Again the open suctioning in the same patient was performed after at least 30 minutes closed suctioning is done. In this manner the catheter placed in the ventilatory circuit and the possibility of suctioning performed without removing the patient from the ventilator.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamadan's Besat Hospital
Full name of responsible person
Ali Afshari, MSc Student in Critical care nursing
Street address
Besat Hospital, Motahari blv, Hamadan
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research & technology, Hamadan university of medical sciences
Full name of responsible person
Ali Ghaleiha
Street address
Hamadan university of medical sciences, Shahid Fahmideh st, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research & technology, Hamadan 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
Hamadan university of medical sciences
Full name of responsible person
Ali Afshari
Position
MSc Student in Critical care nursing
Other areas of specialty/work
Street address
Hamadan university of medical sciences, Shahid Fahmideh st, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1251 9636
Fax
Email
afshari@umsha.ac.ir; ali.ems77@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Ali Afshari
Position
MSc Student in Critical care nursing
Other areas of specialty/work
Street address
Hamadan university of medical sciences, Shahid Fahmideh st, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1251 9636
Fax
Email
afshari@umsha.ac.ir; ali.ems77@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Ali Afshari
Position
MSc Student in Critical care nursing
Other areas of specialty/work
Street address
Hamadan university of medical sciences, Shahid Fahmideh st, Hamadan
City
Hamadan
Postal code
Phone
Fax
Email
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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