Comparing the effect of open and closed endotracheal suctioning on hemodynamic indices, oxygen saturation, and pain in post CABG patients under mechanical ventilation.
The main objective of this study is comparing the effect of open and closed endotracheal suctioning on hemodynamic indices, oxygen saturation and pain in post CABG patients under mechanical ventilation.
Design:
150 patients who needed endotracheal suctioning in CSICU following CABG were randomly allocated to undergo either closed (n=75) or open (n=75) suctioning. After getting oxygenated with 100% O2 for one minute, the patients are suctioned with either methods for 15 seconds. They will also receive 100% oxygen for one minute after suctioning. Pain score using critical pain objective tool (CPOT) is compared during suctioning between two groups. Mean arterial pressure, heart rate and peripheral oxygen saturation are compared after suctioning at one minute intervals for 5 minutes between two groups.This study is single-blind, parallel clinical trial.
Inclusion criteria:
Patients without primary lung pathophysiology; lack of dysrhythmia; Age more than 18; Hemodynamic stability; lack of intracranial hypertension; PEEP<10 CMH2O; FIO2<60%; PFRatio>200; RASS = 0, -1
Exclusion criteria:
Any serious adverse effects during study.
Intervention:
In one group closed suction method and in another open suction method will perform.
Main outcome measures:
Severity of pain, for Pain score, using critical pain objective tool (CPOT) that is measured during suctioning.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042713134N1
Registration date:2013-06-16, 1392/03/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-16, 1392/03/26
Registrant information
Name
Sahereh Mirzaei
Name of organization / entity
Gonabad university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3514
Email address
mirzaei.s@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad university of medical sciences.
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-06, 1392/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of open and closed endotracheal suctioning on hemodynamic indices, oxygen saturation, and pain in post CABG patients under mechanical ventilation.
Public title
Comparing the effect of open and closed endotracheal suctioning on mean arterial pressure, heart rate, oxygen saturation, and pain in post CABG patients under mechanical ventilation.
Purpose
Supportive
Inclusion/Exclusion criteria
Major Inclusion criteria:
Patients without primary lung pathophysiology; lack of dysrhythmia; Age more than 18 years old; Hemodynamic stability; lack of intracranial hypertension; PEEP<10 CMH2O; FIO2<60%; PFRatio>200; RASS = 0, -1
Exclusion criteria:
Any serious adverse effects during study such as; new cerebral side effects; dangerous dysrhythmia; Drop of oxygen saturation during suctioning.
Age
From 18 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Gonabad university of medical sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi
City
Gonabad
Postal code
Approval date
2013-03-03, 1391/12/13
Ethics committee reference number
91/5/7
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Severity of Pain
Timepoint
Before and during suctioning
Method of measurement
CPOT
Secondary outcomes
1
Description
Mean arterial pressure
Timepoint
Before and immediately after suctioning and then every minute up to five minutes
Method of measurement
Observation and record
2
Description
Pao2
Timepoint
Before and immediately after suctioning and then every minute up to five minutes
Method of measurement
Observation and record
3
Description
Heart rate
Timepoint
Before and immediately after suctioning and then every minute up to five minutes
Method of measurement
Observation and record
4
Description
Spo2
Timepoint
Before and immediately after suctioning and then every minute up to five minutes
Method of measurement
Observation and record
5
Description
Paco2
Timepoint
Before and immediately after suctioning and then every minute up to five minutes
Method of measurement
Observation and record
6
Description
Bronchospasm
Timepoint
Before and immediately after suctioning and then every minute up to five minutes
Method of measurement
Observation and records
7
Description
Arrhythmia
Timepoint
Before and immediately after suctioning and then every minute up to five minutes
Method of measurement
Observation and record
Intervention groups
1
Description
After getting oxygenated with 100% O2 for one minute, the patients are suctioned with closed suction method for 15 seconds. The catheter will insert into the endotracheal tube until resistance meet and withdraw 0.5 cm. A negative pressure of maximum 20 KPa will set, and catheter will withdraw. They will also receive 100% oxygen for one minute after suctioning.
Category
Prevention
2
Description
After getting oxygenated with 100% O2 for one minute, the patients are suctioned with open suction method for 15 seconds. The catheter will insert into the endotracheal tube until resistance meet and withdraw 0.5 cm. A negative pressure of maximum 20 KPa will set, and catheter will withdraw while gently rotating. They will also receive 100% oxygen for one minute after suctioning.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr. Shahram Amini
Street address
CSICU, Imam Reza Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Gonabad university of medical sciences
Full name of responsible person
Dr. Ali Mohammad pour Vice chancellor for research, Gonabad University of Medical Sciences
Street address
Jadeye Asiaee
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Gonabad 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
Gonabad university of medical sciences
Full name of responsible person
Sahereh Mirzaei
Position
Student of master degree in critical care nursing / Nurse
Other areas of specialty/work
Street address
Asiaee road
City
Gonabad
Postal code
Phone
+98 53 3722 3028
Fax
Email
sahereh_mirzaei@yahoo.com, mirzaei.s@gmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Dr. Shahram Amini
Position
ICU fellowship
Other areas of specialty/work
Street address
Imam Reza hospital, Imam Reza square, Ibn sina street
City
Mashhad
Postal code
Phone
+98 51 1852 5208
Fax
Email
aminish@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad university of medical sciences
Full name of responsible person
Sahereh Mirzaei
Position
Student of master degree in critical care nursing / Nurse
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi
City
Gonabad
Postal code
Phone
+98 53 3722 3028
Fax
+98 53 3722 3814
Email
sahereh_mirzaei@yahoo.com, mirzaei.s@gmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)