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The effect of expiratory rib cage compression before endotracheal suctioning on hemodynamic changes in mechanically ventilated patients in ICU

Protocol summary

Summary
This research is clinical trial study to determine the effect of rib cage compression on hemodynamic changes in patients under mechanical ventilation in intensive care units.The samples included of 58 mechanically ventilated patients .The patients will be selected gradually according to inclusion criteria .Inclusion criteria includes:age 18 to 65 years, having endotracheal tube for 24 hour, stable hemodynamic status (mean arterial pressure between 110 to 60 mm Hg, heart rate of less than 110 beats per minute ), lack of a chest tube, no chest surgery or injuries, no rib fractures,, no skin grafts and reconstructive surgery of the chest,no pregnancy, obesity (body mass index (BMI)> 30).The procedure is that patients randomly are divided into two groups.In intervention group,patients receive expiratory rib cage compression before suctioning three times a day and control group receive routine suction without rib cage compression. Then 5 min before and 15,25 min after intervention, blood pressure, heart rate and O2saturaion measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016021326537N1
Registration date: 2016-05-12, 1395/02/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-05-12, 1395/02/23
Registrant information
Name
Maryam Yaghoubi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3223 1523
Email address
yaghoubi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of expiratory rib cage compression before endotracheal suctioning on hemodynamic changes in mechanically ventilated patients in ICU
Public title
The effect of expiratory rib cage compression before endotracheal suctioning on hemodynamic changes
Purpose
Other
Inclusion/Exclusion criteria
Iclusionl criteria: age 18 to 65 years, having endotracheal tube for 24 hour, stable hemodynamic status (mean arterial pressure between 110 to 60 mm Hg, heart rate of less than 110 beats per minute), lack of a chest tube, no chest surgery or injuries, no rib fractures, no skin grafts and reconstructive surgery of the chest,no pregnancy, obesity (body mass index (BMI)> 30) Exclusion criteria: mucolytic and muscle paralysis drugs, start, stop, or change the bronchodilator medications during the study, extubation during the study period, using paralyze anesthesia
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: 58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz University of Medical Sciences
Street address
Zip cod:61357-15794, second floor, Golestan highway, Ahvaz University of Medical Sciences, Ahvaz, , Iran
City
Ahvaz
Postal code
6135715794
Approval date
2016-01-27, 1394/11/07
Ethics committee reference number
IR.AJUMS.REC.1394.589

Health conditions studied

1

Description of health condition studied
Mechanically ventilated patients
ICD-10 code
J00-J99
ICD-10 code description
Diseases of the respiratory system

Primary outcomes

1

Description
Blood pressure
Timepoint
Bp will be measured three times: five minutes prior to the endotracheal suctioning, and 15 and 25 minutes following the procedure
Method of measurement
using of the Sphygmomanometer

2

Description
O2 Saturation
Timepoint
SpO2 will be measured three times: five minutes prior to the endotracheal suctioning, and 15 and 25 minutes following the procedure
Method of measurement
with pulse Oximetry (Monitor observation)

3

Description
Heart Rate
Timepoint
HR will be measured three times: five minutes prior to the endotracheal suctioning, and 15 and 25 minutes following the procedure
Method of measurement
Via monitor observation

Secondary outcomes

1

Description
Respiratory Rate
Timepoint
Respiratory rate will be measured three times:five minutes prior to the endotracheal suctioning, and 15 and 25 minutes following the procedure
Method of measurement
Counting the respiratory rate of the patient

Intervention groups

1

Description
In intervention group use expiratory ribcage compression befor suctioning .Then standard suction is done during three times a day
Category
Prevention

2

Description
In control group suctioning without rib cage compression is done
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Glostan hospital in Ahvaz city
Full name of responsible person
Maryam Yaghoubi
Street address
Zip code:6931366853, Mostafa hospital, Keshvary square, Ilam city
City
Ilam

2

Recruitment center
Name of recruitment center
Emam Khomaini hospital in Ahvaz
Full name of responsible person
Maryam Yaghoubi
Street address
Zip code:6931366853, Mostafa hospital, Keshvary square, Ilam city
City
Ilam

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research of Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Nasrin Elahi
Street address
Zip cod:61357-15794, second floor, Golestan highway, Ahvaz University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
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 of Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Yaghoubi
Position
Nursing Critical Care Graduate Student (MSc)
Other areas of specialty/work
Street address
Zip code:6931366853, Mostafa hospital, Keshvary square, Ilam city
City
Ilam
Postal code
6931366853
Phone
+98 84 3223 1523
Fax
Email
m4ry4myaghoubi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Baraz
Position
Assistant Professor
Other areas of specialty/work
Street address
Zip cod:61357-15794, Golestan highway, Ahvaz University of Medical Sciences, Ahvaz, , Iran
City
Ahvaz
Postal code
Phone
+98 61 3373 8621
Fax
Email
shahrambaraz@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Yaghoubi
Position
Nursing Critical Care Graduate Student (MSc)
Other areas of specialty/work
Street address
Zip code:6931366853, Mostafa hospital, Keshvary square, Ilam city
City
Ilam
Postal code
6931366853
Phone
+98 84 3223 1523
Fax
Email
m4ry4myaghoubi@gmail.com
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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