Protocol summary

Summary
Objective: Comparison of the effects of shallow and deep endotracheal suctioning methods on physiological indices and airway clearance in patients hospitalized in intensive care units of Al-Zahra Hospital in 2013. Study design: Randomized clinical trial. Study population: patients admitted to the intensive care unit at Al-Zahra Hospital. 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: patients who would discontinue voluntarily; extubation during the study; become unstable hemodynamic parameters such as bradycardia, arrhythmia, cyanosis, loss of arterial oxygen. Sample Size: 74 patients. Intervention: using shallow endotracheal suction in shallow suction group and deep endotracheal suction in deep suction group. Time of intervention: shallow and deep endotracheal suction will be performed for each group. Design variables will be taken immediately before, immediately after, 1, 2 and 3 minutes after endotracheal suctioning in both groups. Primary outcomes: changes in physiological indices.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012123111954N1
Registration date: 2013-05-01, 1392/02/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-01, 1392/02/11
Registrant information
Name
Mohammad Abbasinia
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2917
Email address
irajpour@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2013-04-09, 1392/01/20
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effects of shallow and deep endotracheal suctioning methods on physiological indices and airway clearance in patients hospitalized in intensive care units of Al-Zahra Hospital in 2013.
Public title
The effects of endotracheal suctioning methods on physiological indices and airway clearance
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 19 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
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
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
Approval date
2013-04-09, 1392/01/20
Ethics committee reference number
392015

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
Blood pressure
Timepoint
Immediately before, immediately after, and 1 and 2 min after endotracheal suctioning
Method of measurement
Vital signs monitor

2

Description
Heart Rate
Timepoint
Immediately before, immediately after, and 1 and 3 min after endotracheal suctioning
Method of measurement
Vital signs monitor

3

Description
Respiratory Rate
Timepoint
Immediately before, immediately after, and 1 and 3 min after endotracheal suctioning
Method of measurement
Vital signs monitor

4

Description
Spo2
Timepoint
Immediately before, immediately after, and 1 and 3 min after endotracheal suctioning
Method of measurement
Vital signs monitor

5

Description
Number of endotracheal suctioning
Timepoint
After each endotracheal suctioning
Method of measurement
Counting the number of endotracheal suctioning

Secondary outcomes

empty

Intervention groups

1

Description
In shallow suction group the suction catheter insert to the end of the endotracheal tube. Then negative pressure performs while pulling out the catheter.
Category
Prevention

2

Description
In deep suction group the suction catheter insert until resistance is met, then it withdraw by 1 cm before application of negative pressure.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Abbasynia Mohammad (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
Abbasinia Mohammad
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
Phone
+98 31 1792 2917
Fax
Email
irajpour@nm.mui.ac.ir; abbasyniamohammad@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
Irajpour Alireza
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
Phone
+98 31 1792 2917
Fax
Email
irajpour@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
Abbasynia Mohammad
Position
student of MSc in critical care nursing
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
irajpour@nm.mui.ac.ir; abbasyniamohammad@yahoo.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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