1- Objectives : The aim of this study was to investigate the effect of endotracheal tube cuff pressure on sore throat, hoarseness and cough in patients with cardiac artery bypass surgery.
2- Design : This quasi-experimental clinical trial in 72 patients undergoing coronary artery bypass graft surgery in Afshar Hospital of Yazd in 2016 .
3- Setting and Conduct : The sampling easy and assigned to two experimental and control groups was carried out.
4- Intervention : In the control group and by the anesthesiologist routine tracheal cuff pressure was adjusted . In the experimental group , after being intubated by standard manometer, pressure cuff at a rate of 2 ± 22 cm of water was regulated and controlled. Data hoarseness, sore throat and cough are 2 , 6 , 12 and 24 hours in both groups by measuring scales , collecting and using statistical software SPSS 20 , were analyzed.
5- Participants including major eligibility criteria : Inclusion criteria were: age between 18 - 75 years ; A patient for surgery was selected for the first time ; They are between 1 - 4 hours and the duration of intubation during surgery less than 24 hours to prevent the impact of other detrimental factors ; And those with a history of sore throat and pharyngitis to 4 weeks prior to surgery ; And a history of respiratory problems ; Addictions, smoking and drug allergy ; As well as patients in the study were throat pain unbearable or housing request ; Longer than 30 seconds for intubation needed ; Or during the study needs to be repeated or replacing the pipes or more than 24 hours under ventilation were excluded from the study.
6- main outcome measures) (variables) : Sore throat, Hoarseness and Cough.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042633657N1
Registration date:2017-06-11, 1396/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
Mohammad Hassan Mondegari Bamakan
Name of organization / entity
School of Nursing & Midwifery, Shahid Sadughi University of Medical Science, Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 3524 8268
Email address
mh.mandegari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Nursing and Midwifery Yazd
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Endotracheal Tube Cuff Pressure on Sore Throat, Hoarseness and Cough in Patients with Coronary Artery Bypass Surgery
Public title
Investigating the Effect of Endotracheal Tube Cuff Pressure on Sore Throat, Hoarseness and Cough
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria were: age between 18 - 75 years ; A patient for surgery was selected for the first time ; They are between 1- 4 hours ; And the duration of Intubation during surgery less than 24 hours to prevent the impact of other detrimental factors ; Risks of surgery at level 1 and 2 ; and the tracheal tube according to the sex of the patient ; As well as not having a history of head and neck surgery ; Anesthesia, medications used was similar adjustments ventilator for all patients ; And those with a history of sore throat and pharyngitis to 4 weeks prior to surgery ; And a history of respiratory problems ; Addictions, smoking and drug allergy ; As well as patients in the study were throat pain unbearable or housing request ; Inotrope drugs or vasodilator in the intensive care unit received more than 10 microns ; Longer than 30 seconds for intubation needed ; Or during the study needs to be repeated or replacing the pipes or more than 24 hours under ventilation were excluded from the study.
Age
From 77 years old to 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
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 Shahid Sadughi University Of Medical Siences
Street address
In Front of the Infertility Center, Bu Ali street , Safaieh
City
Yazd
Postal code
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
ir.ssu.rec.1395.030
Health conditions studied
1
Description of health condition studied
Angina pectoris
ICD-10 code
I20
ICD-10 code description
Angina pectoris
Primary outcomes
1
Description
Sore Throat
Timepoint
2 hours, 6 hours, 12 and 24 hours after Extubation
Method of measurement
To search for pain from zero to 3 ; (Zero score : without sore throat ; a score of 1 : Mild sore throat (only if the person to ask) ; score 2 : moderate sore throat (pharyngitis expressed by the patient) ; grade 3 : severe sore throat (change in volume with sore throat))
2
Description
Hoarseness
Timepoint
2 hours , 6 hours , 12 and 24 hours after Extubation
Method of measurement
As well as a change in sound quality was defined Hoarseness and its severity was determined by 4 degrees from zero to three (zero score : without hoarseness ; 1 score : violence that only by patient reported noise during the interview ; the score 2 : clear sound but mild violence ; Score 3 : violence clear sound and sharp) and transfer the patient to the intensive care unit after surgery
3
Description
Cough
Timepoint
2 hours , 6 hours , 12 and 24 hours after Extubation
Method of measurement
To measure any cough or mild and the extreme of the scale was 0 to 4 (zero score: without coughing ; rare 1: score ; score 2 : casual less than an hour ; score 3 : repeated one or more times an hour ; the score 4 : almost unchanged)
Secondary outcomes
empty
Intervention groups
1
Description
In the Intervention group, after intubated by an anesthesiologist (with more work experience of 5 years) (using the touch pad cuff), by trained nurses with listed for the control group (during the first 10 minutes of anesthesia) was set at a rate of 22 ± 2 cm of water (in the first endotracheal tube cuff pressure measurement, if the level it was different with the rate of 22 ± 2, first, the correction was recorded). At the time of admission to intensive care unit and in the interval of 2 hours, 4 hours and 6 hours after control and this amount has been set. Then, after removing the tube samples both within 2 hours, 6 hours, 12 and 24 hours later, by measure sore throat, cough and hoarseness, in terms of throat pain, cough and respiratory violence are investigated and recorded.
Category
Treatment - Drugs
2
Description
In order to collect data, demographic data and medical records endotracheal tube cuff pressure was used. In the Control group, patients with endotracheal tube cuff pressure by the anesthesiologist (with more work experience of 5 years) with a 10 cc syringe using the touch pad cuff; during the first 10 minutes of anesthesia, time of admission to the intensive care unit and then in a period of 2 hours, 4 hours and 6 hours later using a handheld German construction company pressure measurement range between zero and 120 cm of water, was measured and recorded. In this study, all patients participating in the study tracheal tube made of PVC with a life company (Intellectuals Health) brand was used, but lead. So that for women size 7 - 7.5 and for men Size 8 - 8.5 Used .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Hospital
Full name of responsible person
Bashardoost And Andisheh ICU
Street address
Afshar Hospital , Gomhuri BLV, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Sadughi University of Medical Sciences
Full name of responsible person
Ali Akbar Vaezi
Street address
In Front of the Infertility Center, Bu Ali street , Safaieh
City
yazd
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, Shahid Sadughi 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
Yazd School of Nursing and Midwifery
Full name of responsible person
Mohammad Hassan Mondegari Bamakan
Position
Msn in Critical Care Nursing
Other areas of specialty/work
Street address
Yazd School of Nursing and Midwifery, In Front of the Infertility Center , Bu Ali Street , Safaieh
City
Yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
mh.mandegari@ssu.ac.ir,mondegaribamakan@gmail.com
Web page address
www.ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadughi University Of Medical Sciences - Yazd
Full name of responsible person
Ali Akbar Vaezi
Position
Department of Nursing, School of Nursing & Midwifery, Research Center for Nursing & Midwifery Care i
Other areas of specialty/work
Street address
Yazd School of Nursing and Midwifery, In Front of the Infertility Center , Bu Ali Street , Safaieh
City
Yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
vaeziali@ssu.ac.ir
Web page address
www.ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd School of Nursing and Midwifery
Full name of responsible person
Mohamad Hassan Mondegari Bamakan
Position
Msn In Critical Care Nursing
Other areas of specialty/work
Street address
Yazd School of Nursing and Midwifery, In Front of the Infertility Center , Bu Ali Street , Safaieh
City
Yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
mh.mandegari@ssu.ac.ir
Web page address
www.ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)