Incidence of respiratory and ventilator-associated events in patients intubated with RAE or spiral endotracheal tubes in head and neck surgery
Design
500 patients based on the studies and statistical calculations that meet the inclusion criteria and according to the order of referral will be selected and base on Randlist software will be divided into controlo&intervention groups.In the control group, the RAE tube will be used for endotracheal intubation and in the intervention group, the spiral tube will be used.This study is a randomized, double blind clinical trial with control group
Settings and conduct
study will be performed in the operating room of Imam Reza Hospital in Tabriz.After premedication with fentanyl 1µg/kg,midazolam 0.02 mg/kg, induction of anesthesia will be done by propofol3mg/kg and atracurium40-50mg. Then, hemodynamic variables including blood pressure,heart rate and oxygen saturation will be measured and recorded every 5 minutes by the anesthesiologist.Penlon/PrimaSP2 Ventilator will be used in all patients. Respiratory modes will be in volume control modes with a target volume of 8-6cc/kg and the upper limit of acceptable airway pressure will be adjusted to 40 CmH2O. increase airway pressure,tube kinking,inability to properly ventilate and require tube inspection or endotracheal tube replacement will be recorded. In this study, anesthesiologists and patients will be blinded to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:patient undergoing head and neck surgery with ASA1&2.
Exclusion criteria:obstructive sleep apnea
Respiratory tract infection over the last 2 weeks
wheeze 3 or more times in 12 months
wheezing during exercise
Intervention groups
RAE endotracheal tube will use in control group and spiral endotracheal tube will use in intervention group
Main outcome variables
ventilatory and respiratory complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150125020795N9
Registration date:2019-12-11, 1398/09/20
Registration timing:prospective
Last update:2019-12-11, 1398/09/20
Update count:0
Registration date
2019-12-11, 1398/09/20
Registrant information
Name
Samad Golzari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3556 6183
Email address
golzaris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Incidence of respiratory and ventilator-associated events in patients intubated with RAE or spiral endotracheal tubes in head and neck surgery
Public title
respiratory and ventilator-associated events in patients intubated with RAE or spiral endotracheal tubes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing head and neck surgery are classified as Class 1 or 2 as defined by the ASA Class
Exclusion criteria:
Patients with a history of obstructive sleep apnea
Respiratory tract infection over the last 2 weeks
Wheeze 3 or more times in 12 months
A history of asthma in the absence of wheezing
Wheezing during exercise
Persistent nacturnal dry cough
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
500
Randomization (investigator's opinion)
Randomized
Randomization description
according to the order of referral will be selected and base on Randlist software will be divided into controlo&intervention groups
Blinding (investigator's opinion)
Double blinded
Blinding description
An anesthesiologist who assesses the ventilatory and respiratory complications of patients will be blind.Patients will also be unaware of the type of endotracheal tube used in intubation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz university of medical sciences,Golgasht st,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-07-03, 1398/04/12
Ethics committee reference number
IR.TBZMED.REC.1398.404
Health conditions studied
1
Description of health condition studied
Intubation with RAE and spiral endotracheal tube in head and neck surgery
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Amount of airway pressure despite anesthesia and muscle relaxation
Timepoint
The entire duration of surgery
Method of measurement
Ventilation and respiratory complications questionnaire
2
Description
Endotracheal Tube kinking
Timepoint
The entire duration of surgery
Method of measurement
Ventilation and respiratory complications questionnaire
3
Description
Amount of proper ventilation
Timepoint
The entire duration of surgery
Method of measurement
Ventilation and respiratory complications questionnaire
4
Description
Need to endotracheal tube inspection
Timepoint
The entire duration of surgery
Method of measurement
Ventilation and respiratory complications questionnaire
5
Description
Need to endotracheal tube replacment
Timepoint
The entire duration of surgery
Method of measurement
Ventilation and respiratory complications questionnaire
Control group: Patients undergoing RAE tube intubation
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza hospital
Full name of responsible person
Samad jamal eslam golzari
Street address
Emamreza hospital,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
51666-14756
Phone
+98 41 3334 7059
Fax
+98 41 3334 7059
Email
info@imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Street address
Department of Anesthesiology,Faculty of Medicine,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Samad Jamal Eslam Golzari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology DepartmentوFaculty of Medicine,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
51666-14766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam jamal golzari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department,Faculty of Medicine,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anestesiology,Faculty of Medicine,Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
golzaris@tbzmed.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the study participants' individual data is shared after unidentifiable individuals.
When the data will become available and for how long
access period will be 6 months after printing results
To whom data/document is available
Documents will be available for people working in academia institution and also people working in businesses.
Under which criteria data/document could be used
There are no specific restrictions on the use of data or documentation
From where data/document is obtainable
You can contact Dr. Samad Jamal Islam Golzari for the required documentation or data through the following contact ways:
adress:Anesthesiology department,faculty of medicine,Golgasht street
Tel number:0984133341994
mobile number:0989141151894
Email adress:golzaris@tbzmed.ac.ir
What processes are involved for a request to access data/document