Investigating and comparing the effects of open and closed tracheal suction system on the pain and respiratory indicators in patients under mechanical ventilation in intensive care units
Investigating and comparing the effects of open and closed tracheal suction system on the pain in patients under mechanical ventilation in intensive care units
Design
Clinical trial with intervention group (closed suction) and control group (open suction), single-blind due to statistics analyst, random allocation
Settings and conduct
Closed suction for the intervention group and open suction for the control group are performed by the researcher based on the patients' needs and according to the 2014 suction protocol in Intensive Care Units of Al-Zahra Hospital in Isfahan. Before suctioning, in order to access the patient's basic information, respiratory and pain indicators are recorded at three twenty minute intervals, and the mean is considered as the patient's basic status. Respiratory indicators are recorded in the special form by the researcher's colleague before, 10 minutes after and 30 minutes after the suction; similarly, pain indicators are recorded before, during, 10 minutes and 30 minutes after the suction.This study is single-blind due to statistics analyst blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
patients undergoing volumetric mechanical ventilation; hospitalized in ICU with no suction contraindication and zero or -1 RASS;
Exclusion criteria:
patients who face with hemodynamic dysfunction or life threatening conditions.
Intervention groups
All patients with inclusion criteria will be divided into two groups of closed suction and open suction using Minimization software. In the closed suction or intervention group, closed suctioning and in the open suction or control group, open suctioning are performed.
Main outcome variables
Respiratory and pain indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180108038267N1
Registration date:2018-02-23, 1396/12/04
Registration timing:retrospective
Last update:2018-02-23, 1396/12/04
Update count:0
Registration date
2018-02-23, 1396/12/04
Registrant information
Name
somayeh ghafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7517
Email address
somayeghafari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2017-12-22, 1396/10/01
Trial completion date
empty
Scientific title
Investigating and comparing the effects of open and closed tracheal suction system on the pain and respiratory indicators in patients under mechanical ventilation in intensive care units
Public title
comparing two close suction and open suction method in patients under mechanical ventilation in intensive care units
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
admission to the ICU of the hospital
Being at the age of 18-70 years
no history of cardiac diseases
no primary pulmonary pathophysiology
ventilation with Synchronized Intermittent Mandatory Ventilation (SIMV)
Positive End Expiratory Ventilation (PEEP)=3-5 cm H2O
Tidal Volume(TV)=8 – 10 ml/kg
Fractional Inspired Oxygen(FIO2)=40% to 60%
Pressure Support Ventilation (PSV)=8 -10 cm
no coagulation disorder or thrombocytopenia
Richmond Agitation Sedation Scale (RASS) =0,-1
Exclusion criteria:
hemodynamic instability (in systolic blood pressure (SBP) less and greater than 20 mmHg and in diastolic blood pressure (DBP) less and greater than 20 mmHg)
having cardiac arrhythmia
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients eligible for the research will be selected by simple method and then, using Minimization software, are divided into two open and closed suction groups. This software, based on the variables of sex, age, BMI, and spo2, divides the patients into two open and closed suction groups in such a way that the groups have the least difference.
Blinding (investigator's opinion)
Single blinded
Blinding description
Open and closed suction are performed by the researcher and the data is recorded by the researcher's colleague who is one personnel of ICU and, hence, the researcher is not aware of the recorded data.
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, Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-02-21, 1394/12/02
Ethics committee reference number
IR.MUI.REC.1394.3.976
Health conditions studied
1
Description of health condition studied
patients under mechanical ventilation in intensive care units
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient's level of pain
Timepoint
Before the suction, during the suction, ten minutes and thirty minutes after the suction.
Method of measurement
CPOT scale
2
Description
Respiratory indicators
Timepoint
Before the suction, ten minutes and thirty minutes after the suction
Method of measurement
Monitoring of patient-ventilator
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, closed suction is performed while the patient is connected to a mechanical ventilator due to the need of patient, by the researcher according to the 2014 protocol. Respiratory Indicators including respiratory rate, arterial oxygen saturation, minute ventilation, static and dynamic compliance and pain recorded by monitoring and pain assessment tool are registered in the data collection form by a researcher before, 10 minutes and thirty minutes after suctioning.
Category
Treatment - Devices
2
Description
Control group: The open suction is done by removing the patient from the ventilator by the researcher according to the 2014 protocol. Respiratory Indicators including respiratory rate, arterial oxygen saturation, minute ventilation, static and dynamic compliance and pain recorded by monitoring and pain assessment tool are registered in the data collection form by a researcher before, 10 minutes and thirty minutes after suctioning.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Fariba Taleghani
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7544
Fax
+98 31 3669 9398
Email
ftmkhaier@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Taleghani
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7544
Fax
+98 31 3669 9398
Email
ftmkhaier@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Khaier
Position
Critical Care Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7544
Email
ftmkhaier@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Ghafari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7544
Email
somayehghafari@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Ghafari
Position
Associate professor in nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7544
Email
somayehghafari@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No plan has been considered yet to publish the results. There is no further information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available