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Trial registered on ANZCTR


Registration number
ACTRN12614000405617
Ethics application status
Approved
Date submitted
17/03/2014
Date registered
14/04/2014
Date last updated
21/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative study of orotracheal intubation through Air Q laryngeal mask airway: Blind versus fiberoptic guided during general anesthesia
Scientific title
Comparative study of orotracheal intubation through Air Q laryngeal mask airway: Blind versus fiberoptic guided during general anesthesia
Secondary ID [1] 284275 0
nil
Universal Trial Number (UTN)
U1111-1154-5889
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
orotracheal intubation 291408 0
pressor response 291410 0
arousable response 291411 0
Condition category
Condition code
Anaesthesiology 291771 291771 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study was conducted at Beni- Suef University Hospital,Egypt. 100 adult patients ASA I and II undergoing elective surgeries under general anesthesia with orotracheal intubation were divided into two groups according to the technique of intubation through Air-Q ILA. Group I (n= 50) patients intubated blindly using air Q intubating laryngeal airway (Air-Q ILA): the cuff of the Air-Q ILA was deflated until two dimples appear at the back of Air-Q ILA as described by manufacturer and was lubricated with xylocain gel 2% , the Air-Q ILA was inserted into the patients mouth with the upper incisor of the patient opposite the lower landmark on the tube of the air Q ILA to prevent epiglottic folding with the cuff of the Air-Q ILA, the cuff then inflated with 10-15 ml air and connected to the circle system.After confirmation of ventilation by capnography, bilateral chest expansion , and bilateral auscultation of breath sounds the air Q ILA mask adaptor was disconnected, a well lubricated PVC endotracheal tube (ID 7mm in females,7.5 in males)was advanced through its shaft blindly then connected to the circle system, successful endotracheal intubation and ventilation was confirmed with capnography, then the cuffs of the Air-Q ILA and endotracheal tube were deflated, the ETT connector was removed then the Air-Q ILA was removed over a special stylet, Then, the ETT connector was placed into its position ,the cuff reinflated and the ETT was connected to the circle system, any blood visible on the device indicative of trauma to the upper airway or bronchospasm were recorded If first attempt of intubation failed, the second attempt was done by maximal head extension and mandibular lift,If the second attempt failed, the third attempt was done by fiberoptic bronchooscope through Air-Q ILA.).
Intervention code [1] 289010 0
Treatment: Devices
Comparator / control treatment
In Group II(n=50) patients were intubated through the Air-Q ILA from the start guided by flexible fiberoptic bronchoscpe( KARL STORZ- Endoscope 5.2 x 65): a reusable Air-Q ILA use was lubricated with xylocain gel 2% and inserted into the patient mouth, the cuff then inflated with 10-15 ml and the Air-Q ILAwas connected to the circle system, after confirmation of ventilation, a well lubricated fiberoptic bronchoscope loaded with a proper size well lubricated PVC ETT (ID 7mm in females and 7.5 in males) was advanced through the Air-Q ILA shaft till visualization of the glottic area of the larynx and advancing into the trachea until visualization of the carina then the ETT was advanced into the trachea . The scope then was removed and the ETT cuff was inflated and connected to the circle system, successful endotracheal intubation was confirmed with capnography , adequate chest expansion and bilateral auscultation of breath sounds. The cuff of the Air-Q ILA was deflated then it was removed over a special stylet. Any blood visible on the device, indicative of trauma to the upper airway or bronchospasm was reported
Control group
Active

Outcomes
Primary outcome [1] 291701 0
Time of insertion of the air q ila: stop watch
Timepoint [1] 291701 0
Time of insertion of the endotracheal tube
Primary outcome [2] 291702 0

Number of attempts of insertion of Air-Q ILA
Timepoint [2] 291702 0
Number of attempts of intubation
Secondary outcome [1] 307678 0
Number of patients who failed to be intubated with the device
Timepoint [1] 307678 0
Number of patients who failed to be intubated with the device (after 3 attempts)
Secondary outcome [2] 307712 0
Airway complications: injury to the gums or teeth damage.hoarseness of the voice , bleeding, sore throat.
Timepoint [2] 307712 0
Before leaving the PACU the patients was asked about sore throat and hoarseness. If noted, assessment for 48 hours was done
Secondary outcome [3] 307713 0
Bispectral Index (BIS) values
Timepoint [3] 307713 0
measured before induction of anesthesia, after induction, immediately after intubation and after 5 minutes of endotracheal intubation
Secondary outcome [4] 307714 0
Arterial oxygen saturation (SpO2); by pulse oximetry
Timepoint [4] 307714 0
before, during and after intubation.
Secondary outcome [5] 307715 0
Systolic arterial blood pressure : by noninvasive blood pressure monitoring
Timepoint [5] 307715 0
preinduction, after induction of anesthesia, then at 1 and 5 minutes after intubation
Secondary outcome [6] 307716 0
diastolic arterial blood pressure :
by noninvasive blood pressure monitoring
Timepoint [6] 307716 0
preinduction, after induction of anesthesia, then at 1 and 5 minutes after intubation
Secondary outcome [7] 307717 0
mean arterial blood pressure: by noninvasive blood pressure monitoring
Timepoint [7] 307717 0
preinduction, after induction of anesthesia, then at 1 and 5 minutes after intubation

Eligibility
Key inclusion criteria
ASA (I–II) planned for elective surgical operations under general anesthesia with oral endotracheal intubation.
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
hypertension, neurological, cardiovascular, endocrine disease, risk of regurgitation and pulmonary aspiration, cervical spine lesion, patients undergoing cardiac and neurosurgical procedures, risk index of El-Ganzouri for difficult tracheal intubation more than or eqaul 4, BMI > 35 kg/m2, oropharyngeal mass, respiratory pathology, or any history of allergy to drugs used in the protocol

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis and data handling
Data are presented as mean+/- SD, number and percentage ,median and rang as appropriate. Unpaired Student t- test was used for comparison between means of the two groups. Mann-Whitney U test was used for comparison of nonparametric data. Chi-square test or Fisher's exact test were used for comparing categorical data. P values = 0.05 were considered statistically significant. Statistical package for social science (SPSS) software version 17 was used."Sample size was calculated based on a previous study (El-Ganzouri AR, Marzouk S, Abdelalem N and Yousef M: Blind versus fiberopticlaryngoscopic intubation through air Q laryngeal mask airway, Egypt J Anesth,2011; 27: 213–8.) which included 40 patients in each group, we increased the size to 50 patient per group to compensate if any case excluded due to failure or difficult technique.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/06/2013
Actual
5/06/2013
Date of last participant enrolment
Anticipated
Actual
1/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5897 0
Egypt
State/province [1] 5897 0
benisuef

Funding & Sponsors
Funding source category [1] 288902 0
Hospital
Name [1] 288902 0
benisuef university hospital
Country [1] 288902 0
Egypt
Funding source category [2] 288918 0
Self funded/Unfunded
Name [2] 288918 0
personal
Country [2] 288918 0
Egypt
Primary sponsor type
University
Name
faculty of medicine benisuef university
Address
egypt,benisuef governerate
-,mokbel, 62511
Country
Egypt
Secondary sponsor category [1] 287669 0
None
Name [1] 287669 0
Address [1] 287669 0
Country [1] 287669 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290734 0
research ethical comittee
Ethics committee address [1] 290734 0
benisuef governerate
-,mokbel, 62511
benisuef faculty of medicine
(FMBUS)
Ethics committee country [1] 290734 0
Egypt
Date submitted for ethics approval [1] 290734 0
Approval date [1] 290734 0
Ethics approval number [1] 290734 0

Summary
Brief summary
Background:Tracheal intubation is the gold standard for securing the airway, laryngoscopy and endotracheal intubation induce pressor response which is of concern in patients with cardiac diseases and patients with cerebrovascular lesions, not only laryngoscopy and tracheal intubation cause cardiovascular responses but also induce an arousal response on the EEG .The AIR-Q intubating Laryngeal Mask (Air-Q ILA Cookgas LLC; distributed by Mercury Medical)is a new supraglottic device with the following advantages: ease of insertion, reliable alignment of the glottis opening, ability for continuous oxygenation and ventilation .
Methods:
This study was conducted at Beni- Suef University Hospital,Egypt, 100 adult patients ASA I and II undergoing elective surgeries under general anesthesia with orotracheal intubation were divided into two groups according to the technique of intubation through Air-Q ILA
Group I (n= 50)patients intubated blindly through Air-Q ILA
Group II (n=50) patients intubated through Air-Q ILA guided by flexible fiberoptic bronchoscope.
The following parameters were recorded: Heart rate,systolic, diastolic and mean arterial blood pressure and Bispectral Index (BIS) values: preinduction, after induction of anesthesia, then at 1 and 5 minutes after intubation ,arterial oxygen saturation (SpO2): before, during and after intubation,time of insertion(in seconds) and number of attempts of insertion of the Air-Q ILA and endotracheal tube and airway complications; injury to the gums or teeth damage, hoarseness of the voice , bleeding, sore throat.
Results:
Systolic and mean arterial blood pressures were statistically significant lower in the fiberoptic group than blind group. There was no statistically significant difference between the two groups in the heart rate and diastolic blood pressure. Time and number of attempts of insertion of Air-Q ILA were statistically significant lower in fiberoptic group than in blind group. There was statistically significant lower time of intubation and less number of attempts in fiberoptic group than in blind group and success rate of intubation in the fiberoptic group was 100% compared to 76% in blind group. There was statistically significant lower BIS value in the fiberoptic group 1 minute after intubation than in the blind group
Conclusion: endotracheal intubationthrough the Air-Q ILA guided by flexible fiberoptic bronchoscope is associated with less hemodynamic pressor response and arousal response than blind endotracheal intubation through the Air-Q ILA,the number of attempt and time of successful intubation were statistically significantly lower in the fiberoptic group than the blind group
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46994 0
Dr Reham Mohammed Mohammed essawy
Address 46994 0
Reham Mohammed Mohammed essawy
egypt,benisuef governerate
benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511
Country 46994 0
Egypt
Phone 46994 0
+2020822318605
Fax 46994 0
Email 46994 0
Re_esawy@yahoo.com
Contact person for public queries
Name 46995 0
doaa rashwan
Address 46995 0
doaa rashwan egypt,

benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511
Country 46995 0
Egypt
Phone 46995 0
+20822318605
Fax 46995 0
Email 46995 0
doaa_rashwan2007@yahoo.com
Contact person for scientific queries
Name 46996 0
doaa rashwan
Address 46996 0
doaa rashwan egypt,

benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511
Country 46996 0
Egypt
Phone 46996 0
+20822318605
Fax 46996 0
Email 46996 0
doaa_rashwan@hotmail.com

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