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Comparison the effect of two levels of negative pressure in open endotracheal tube suction on physiological indices among patients in intensive care units of Al-Zahra Hospital, Isfahan in 2013

Protocol summary

Summary
Comparison the effect of two levels of negative pressure in open endotracheal tube suction on physiological indices among patients in intensive care units of Al-Zahra Hospital, Isfahan in 2013, Study design: Randomized clinical trial with parallel design, Study population: patients admitted to the intensive care unit at Al-Zahra Hospital, Major inclusion criteria:minimum age 18 years and maximum age 75 years, having endotracheal tube and conect to ventilatore, no coagulation disordere and thrombocytopenia, having stable hemodynamice before suctioning(SBP>100,HR<120,MAP>70) and no hypoxemia(SPO2<90).Major inclusion criteria: age over than 18; obtaining informed consent; no blood clotting disorders; no chronic respiratory disease; intubation time between 48 hours and one week. Major exclusion criteria: extubation during the study; become unstable hemodynamic parameters such as bradycardia, arrhythmia, cyanosis, loss of arterial oxygen.sample size:60, Intervention or interventions: First group suctioned with negative pressure of 100 mmHg and second group with 200 mmHg. Time of intervention:suction with negative pressure 100 and 200mmHg will be perfomed for each group and Design variables will be taken immediately before, during, 5 and 20 minute after endotracheal suctioning in both groups. Primary outcomes: changes in physiological indices

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013041713039N1
Registration date: 2013-07-26, 1392/05/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-26, 1392/05/04
Registrant information
Name
Hojatollah Yousefi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7543
Email address
yousefi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2013-04-11, 1392/01/22
Expected recruitment end date
2013-05-24, 1392/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of two levels of negative pressure in open endotracheal tube suction on physiological indices among patients in intensive care units of Al-Zahra Hospital, Isfahan in 2013
Public title
Comparison the effect of two levels of negative pressure in open endotracheal tube suction on physiological indices among patients in intensive care units of Al-Zahra Hospital, Isfahan in 2013
Purpose
Supportive
Inclusion/Exclusion criteria
Major inclusion criteria: age over than 18; obtaining informed consent; no blood clotting disorders; no chronic respiratory disease; intubation time between 48 hours and one week. Major exclusion criteria: extubation during the study; become unstable hemodynamic parameters such as bradycardia, arrhythmia, cyanosis, loss of arterial oxygen
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical sciences
Street address
Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib Street, Isfahan. Postal cod: 81746-73461
City
Isfahan
Postal code
81746-73461
Approval date
2013-04-09, 1392/01/20
Ethics committee reference number
392012

Health conditions studied

1

Description of health condition studied
Respiratory conditions due to other specified external agents
ICD-10 code
J70.8
ICD-10 code description
Respiratory conditions due to other specified external agents

Primary outcomes

1

Description
Spo2
Timepoint
Immediately before, During, 5 and 20 min after endotracheal suctioning
Method of measurement
Vital signs monitor

Secondary outcomes

1

Description
Heart Rate
Timepoint
Immediately before, During, 5 and 20 min after endotracheal suctioning
Method of measurement
Vital signs monitor

2

Description
MAP
Timepoint
Immediately before, During, 5 and 20 min after endotracheal suctioning
Method of measurement
Vital signs monitor

3

Description
SBP
Timepoint
Immediately before, During, 5 and 20 min after endotracheal suctioning
Method of measurement
Vital signs monitor

4

Description
DBP
Timepoint
Immediately before, During, 5 and 20 min after endotracheal suctioning
Method of measurement
Vital signs monitor

5

Description
Respiratory Rate(RR)
Timepoint
Immediately before, 5 and 20 min after endotracheal suctioning
Method of measurement
Vital signs monitor

Intervention groups

1

Description
this study is a parallel study that First group suctioned with negative pressure of 100 mmHg with standard method
Category
Prevention

2

Description
Scond group suctioned with negative pressure of 200 mmHg with standard method
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital, Intensive Care Units
Full name of responsible person
Jahanbakhsh Vahdatnejad (student of MSc in critical care nursing)
Street address
Al-Zahra Hospital, Sofeh Avenue, Isfahan. Postal cod: 81746-75731
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Peiman Adibi
Street address
Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan. Postal cod: 81746-73461
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Jahanbakhsh Vahdatnejad
Position
student of MSc in critical care nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan. Postal cod: 81746-73461
City
Isfahan
Postal code
73461-81746
Phone
+98 31 1792 2944
Fax
Email
yousefi@nm.mui.ac.ir;jahan_vahdat@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Yousefi Hojatollh
Position
PHD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan. Postal cod: 81746-73461
City
Isfahan
Postal code
73461-81746
Phone
+98 31 1792 2944
Fax
Email
yousefi@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Jahanbakhsh Vahdatnejad
Position
student of MSc in critical care nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib
City
Isfahan
Postal code
73461-81746
Phone
+98 31 1792 2944
Fax
Email
yousefi@nm.mui.ac.ir
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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