Comparing the Open Endotracheal Suctioning and the Closed Endotracheal Suctioning Methods on the Level of Pain and Agitation of Patients under Mechanical Ventilation
The aim of this study was comparing the effectiveness of the open and closed endotracheal suction tube system on the pain and agitation of patients under mechanical ventilation.
The present study was a randomized controlled clinical trial on mechanically ventilated patients hospitalized in the intensive care units of selected hospitals in Tehran. Sixty mechanically ventilated patients who were qualified for being included in the study were randomly assigned to the intervention and the comparison groups using the blocks of four method. In case of a necessity, the suction was carried out for each patient using the standard technique. The patients’ level of pain and agitation was measured in both group at five stages (before, during, immediately, 5 minutes, and 15 minutes after the intervention) using the behavioral pain scale and the Richmond Agitation Sedation Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508268650N6
Registration date:2016-04-01, 1395/01/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-01, 1395/01/13
Registrant information
Name
Abbas Ebadi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 6057
Email address
ebadi1347@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2015-04-01, 1394/01/12
Expected recruitment end date
2015-08-08, 1394/05/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Open Endotracheal Suctioning and the Closed Endotracheal Suctioning Methods on the Level of Pain and Agitation of Patients under Mechanical Ventilation
Public title
Comparing the Open Endotracheal Suctioning and the Closed Endotracheal Suctioning Methods on the Level of Pain and Agitation of Patients under Mechanical Ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The criteria for entering the study consisted of being 18 years of age or older, being an intubated (having a tube in the trachea) and mechanically ventilated patient, having a consciousness level with a Glasgow coma score of 7 or higher, having vital signs within normal limits, not having taken high-dose sedatives and tranquilizers (deep sedition) during the past six hours, having no severe facial trauma, taking dopamine, dobutamine and nitroglycerin according to the physician's orders (not taking them in unconventional doses), having a normal hearing and speaking ability and not being dependent on utilities such as hearing aids, not suffering from a neurological damage affecting breathing (such as quadriplegia), having no record of mental illness and severe neurological problems, and not being affected by neuromuscular diseases.
The exclusion criteria consisted of not receiving the patient’s companion’s consent, tracheal extubation, patient’s being in need of repeated suctioning or suctioning in intervals shorter than 20 minutes, having a reduced level of consciousness during suctioning, dysrhythmia, suffering from a reduced SPO2 level more than 10% during suctioning, and being in need of tranquilizers and painkillers more than the common treatment protocol.
Age
From 18 years old to 94 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Ethics Committee Medical Branch of Tehran
Street address
Khaghani st, Shariati Ave, Tehran, Iran
City
Tehran
Postal code
193951495
Approval date
2016-02-24, 1394/12/05
Ethics committee reference number
IR.IAU.TMU.REC.1394.23
Health conditions studied
1
Description of health condition studied
Patients with impaired respiratory function in ICU
ICD-10 code
J95 , J96
ICD-10 code description
Other diseases of the respiratory system
Primary outcomes
1
Description
Severity of Pain
Timepoint
Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention
Method of measurement
BPS
Secondary outcomes
1
Description
Agitation
Timepoint
Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention
Method of measurement
Richmond Agitation Sedation Scale
2
Description
Heart rate
Timepoint
Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention
Method of measurement
Monitoring Device
3
Description
SPO2
Timepoint
Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention
Method of measurement
Monitoring Device
4
Description
respiration rate
Timepoint
Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention
Method of measurement
Monitoring Device
5
Description
Systolic Blood Pressure
Timepoint
Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention
Method of measurement
Monitoring Device
6
Description
Mean Arterial Blood Pressure
Timepoint
Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention
Method of measurement
Monitoring Device
7
Description
Diastolic Blood Pressure
Timepoint
Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention
Method of measurement
Monitoring Device
Intervention groups
1
Description
In the experimental group (open suction system)
In the beginning, The vital signs were recorded by the monitor. The patient was then hyper-oxygenized with 100% oxygen. Immediately after that, endotracheal suctioning (open) was conducted rotationally for 10 to 15 seconds with a maximum pressure of 120 mm Hg. Following that, the patient was again hyper-oxygenated with 100% oxygen, and hemodynamic variables were recorded at five temporal stages for both groups with the monitoring device. The pain and agitation of the two groups were measured using the Richmond Agitation Sedation Scale at five temporal stages (before, during, immediately, 5 minutes after the suctioning, and 15 minutes after the suctioning).
Category
Prevention
2
Description
In the experimental group (close suction system)
In the beginning, The vital signs were recorded by the monitor. The patient was then hyper-oxygenized with 100% oxygen. Immediately after that, endotracheal suctioning(close) was conducted rotationally for 10 to 15 seconds with a maximum pressure of 120 mm Hg. Following that, the patient was again hyper-oxygenated with 100% oxygen, and hemodynamic variables were recorded at five temporal stages for both groups with the monitoring device. The pain and agitation of the two groups were measured using the Richmond Agitation Sedation Scale at five temporal stages (before, during, immediately, 5 minutes after the suctioning, and 15 minutes after the suctioning).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam ol Anbia Hospital and Sina Hospital
Full name of responsible person
Razieh Dastdadeh
Street address
Tehran, Rashid Yasemi St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of, Islamic Azad University branch of Medical Sciences Tehran
Full name of responsible person
Hasan Eftekhar Ardabili
Street address
Khaghani st, Shariati Ave, Tehran, Iran
City
Tehran
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, Islamic Azad University branch of Medical Sciences Tehran
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
School of Nursing and Midwifery, Islamic Azad University of Tehran
Full name of responsible person
Raziyeh Dastdadeh
Position
Student Of Master Degree In Medical Surgical Nursing
Other areas of specialty/work
Street address
Khaghani st, Shariati Ave, Tehran, Iran
City
Tehran
Postal code
193951495
Phone
+98 21 2200 6660
Fax
Email
r.dastdadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr.Abbas Ebadi
Position
PhD in Nursing Education Associate Professor
Other areas of specialty/work
Street address
Molla sadra st,Tehran,Iran
City
Tehran
Postal code
Phone
00
Fax
+98 21 2612 7237
Email
ebadi1347@bmsu.ac.ir
Web page address
www.bmsu.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)