Postoperative sore throat and the pressure of endotracheal tube cuff filled with air or saline following tracheal intubation in different body positions
Assessment of endotracheal tube cuff pressure filled by air versus saline and postoperative sore throat in patients undergoing abdominal and orthopedic surgery with lateral position
Design
A double-blinded, parallel-group clinical trial with random sampling and allocation in intervention and control group
Settings and conduct
An available double-blinded sampling will be conducted on patients referred to the central operating room of Qaem Hospital, Mashhad. They will be all candidates of 1 to 2-hour abdominal or orthopedic surgery in the lateral position with GA. Neither analyst nor participant will be informed about group allocation. After the intubation in the supine position, the endotracheal tube cuff is filled with saline in intervention and air in control group, until a pressure of 15 cm H2O is reached. Checklist variables are recorded during the surgery (VBM cuff pressure gauge is used in the control group and the transducer and monitoring device of the VECTRA Company is employed in intervention group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: No history of a previous acute or chronic throat, jaw and larynx illness or surgery; Being alert; Not being intubated an endotracheal tube initially; Being able to speak Persian; Having lateral position during the surgery; Scheduled to undergo abdominal and orthopedic Surgery; No history of drug allergy affecting general anesthesia; BMI = 18.5-25 kg/m2 and Exclusion criteria: Mallampati score 3 & 4; ASA more than 3; Duration of intubation more than 20 seconds; The need for steroidal anti-inflammatory and NSAIDs up to 24 hours after surgery
Intervention groups
After the intubation in the supine position, the endotracheal tube cuff is filled with saline in intervention and air in control group respectively, until a pressure of 15 cm H2O is reached.
Main outcome variables
Endotracheal tube cuff pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160516027925N3
Registration date:2018-04-28, 1397/02/08
Registration timing:registered_while_recruiting
Last update:2018-04-28, 1397/02/08
Update count:0
Registration date
2018-04-28, 1397/02/08
Registrant information
Name
Amir Zoka
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3822 4395
Email address
zokaa921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Postoperative sore throat and the pressure of endotracheal tube cuff filled with air or saline following tracheal intubation in different body positions
Public title
Postoperative sore throat and the pressure of endotracheal tube cuff
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of a previous acute or chronic throat, jaw and larynx illness or surgery
Being alert
Not being intubated an endotracheal tube initially
Being able to speak Persian
Having lateral position during the surgery
Scheduled to undergo abdominal and orthopedic Surgery
No history of drug allergy affecting general anesthesia
BMI = 18.5-25 kg/m2
Exclusion criteria:
mallampati score 3&4
ASA more than 3
Duration of intubation more than 20 seconds
The need for steroidal anti-inflammatory and non-steroidal anti-inflammatory drugs up to 24 hours after surgery
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to the control or intervention group by drawing a random number out of a bag
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not be informed about which group they are in. Also, the data analyst will be blind to which group the participants are assigned
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Administration Center(Qoreishi Building), Daneshgah St, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2018-01-31, 1396/11/11
Ethics committee reference number
IR.MUMS.fm.REC.1396.678
Health conditions studied
1
Description of health condition studied
Postoperative cuff pressure after the operation of patients undergoing abdominal and orthopedic surgery with lateral position
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Endotracheal tube cuff pressure
Timepoint
After intubation, before change the position, after change the position, before extubation
Method of measurement
Pressure Gauges endotracheal tube cuff pressure &
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The cuff of the endotracheal tube of the intervention group is filled in with water after the intubation in the supine position until a pressure of 15 cm H2o is reached.
Category
Treatment - Devices
2
Description
Control group: The cuff of the endotracheal tube of the Control group is filled in with air after the intubation in the supine position until a pressure of 15 cm H2o is reached.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem hospital
Full name of responsible person
Mohsen Sabermoghaddam
Street address
Ahmadabad Blvd, Mashhad, Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
zoka.am69@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Sabermoghaddam
Street address
Ahmadabad Blvd, Mashhad, Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
sabermoghaddamm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Amir Zoka
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Unite 14, Block 17, Number 43, Delavaran St., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
092111111111
Phone
+98 51 3822 4395
Fax
Email
zokaa1@thums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Amir Zoka
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Torbat Heydariyeh University of Medical Sciences, Qarani Blvd, Torbat Heydariyeh, khorasan Razavi
City
Mahshad
Province
Razavi Khorasan
Postal code
092111111111
Phone
+98 51 3822 4395
Fax
+98 51 3822 4395
Email
zokaa1@thums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Amir Zoka
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Torbat Heydariyeh University of Medical Sciences, Qarani Blvd, Torbat Heydariyeh, khorasan Razavi
City
Mahshad
Province
Razavi Khorasan
Postal code
092111111111
Phone
+98 51 3822 4395
Fax
+98 51 3822 4395
Email
zokaa1@thums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All de-identified individual participant data will be shared. Both of the entire study protocol and informed consent of the participants in the study are shared too.
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Given the patient's satisfaction to participate in this study, the data should only be used for similar studies
From where data/document is obtainable
Email to the authors
Sabermoghaddamm@mums.ac.ir
Zokaa1@thums.ac.ir
What processes are involved for a request to access data/document
After the email, the request will be made available to the authors to reach the requesting person within a maximum of one month if the conditions are confirmed.