This randomized, single-blinded controlled study to compare the effect of duration And rotational stabilization of the endotracheal tube on incidence of complications in patients intubated intensive care unit is done. Patients 20 to 65 years with a GCS of less than 8 who were intubated in the past 48 hours, samples are selected. The sample size was 132 patients. . After obtaining the written consent of the legal guardian, patients were randomly assigned to two experimental and control groups are divided.
Group Routine, endotracheal tube fixation rotation every 24 hours (n =66 ) is performed. The experimental group underwent endotracheal tube fixation rotation every 12 hours (n = 66) are.
Endotracheal tube for rotational positions in three different directions (right corner of the mouth, the mouth, and left corners of the mouth) which can be moved in three days. Other conditions such as type of bond fixator care of endotracheal tube intubation, length and width and frequency of endotracheal tube cuff deflation will be the same. In both groups to determine the effects of intervention External jugular venous pressure, displacement of the endotracheal tube,, oral hygiene, skin integrity and extubation will be investigated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041927489N1
Registration date:2016-05-09, 1395/02/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-09, 1395/02/20
Registrant information
Name
Fateme Rafiei
Name of organization / entity
Hamedan ,University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0583
Email address
m.rafee@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compared rotated endotracheal tube fixation with routine method on its Complications in intubated patient in Intensive Care Unit
Public title
the effect of rotated endotracheal tube fixation on its Complications
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: - patients with an endotracheal tube through the mouth,Age between 20 and 65, Patients who are intubated for at least the past 48 hours,Lack of skin disease (eczema, psoriasis, skin cancer, etc.),Lack of diseases of the mouth before being intubated,Normal jugular venous pressure (6 to 8 cm) water,Patients have PEEP≤ 10 cm 2 H2O,Lack of metabolic diseases (diabetes),Lack of valvular heart disease - the GCS under 8,Exclusion criteria: Extubated,Death before the end of study
Elevated jugular venous pressure due to other cases such as cardiac tamponade, hypervolemia, and ...
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Hamedan - street shahyd fahmide - across from People,'s Park
City
Hamedan
Postal code
38698-65178
Approval date
2016-04-11, 1395/01/23
Ethics committee reference number
IR.UMSHA.REC.1395.4
Health conditions studied
1
Description of health condition studied
Complications of medical and surgical care (Y40-Y84)
ICD-10 code
Y84.8
ICD-10 code description
Other medical procedures
Primary outcomes
1
Description
External jugular venous pressure
Timepoint
During the three days before and 15 minutes after changing positions
Method of measurement
Ruler (cm)
2
Description
Displacement of the Endotracheal Tube
Timepoint
During the three days before and 15 minutes after changing positions.
Method of measurement
Ruler (cm)
3
Description
Oral hygiene
Timepoint
Every 24 hours during three days
Method of measurement
Scale BRUSHED
4
Description
Extubation
Timepoint
After repositioning the endotracheal tube in three days