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Trial registered on ANZCTR


Registration number
ACTRN12612000799853
Ethics application status
Approved
Date submitted
21/07/2012
Date registered
30/07/2012
Date last updated
30/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Overall efficacy and haemodynamic effects following blind oro-tracheal intubation with Intubating Laryngeal Mask Airway (ILMA) vs conventional direct laryngoscopy guided intubation with Macintosh laryngoscope in patients with normal airway undergoing elective surgery.
Scientific title
To find out whether blind oro-tracheal intubation with Intubating laryngeal mask Airway (ILMA) is more efficacious and maintain better haemodynamics compared to conventional direct laryngoscope guided intubation with Macintosh laryngoscope in patients with normal airway undergoing elective surgery?
Secondary ID [1] 280889 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anaesthesia 286959 0
intubation methods 286960 0
Condition category
Condition code
Anaesthesiology 287299 287299 0 0
Anaesthetics
Respiratory 287314 287314 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Conventionally all patients who undergo surgery under general anaesthesia require intubation of their trachea with help of macintosh Laryngoscope and endotracheal tube.The tracheal intubation using a laryngoscope inevitably involves distortion of the anatomy in order to bring the glottis into the line of sight. In addition the tracheal tube is designed in such a way that it can be passed easily into the trachea only when the anatomy is distorted.
The ILMA is a new device specially designed to guide blind intubation. Various reports have shown that ILMA has advantage over laryngoscope guided tracheal intubation in patients of cervical trauma and difficult airways. It does not require head and neck manipulation for insertion and facilitate better alignment of tracheal tube. This device has also been to used to intubate patients in lateral position. However it is yet to be determined whether ILMA is feasible to use as a primary intubating device in patients with normal airways.
Time required for both the methods of intubation differ from case to case as multiple factors affect them for eg.skill and competency of the intubating person,difficulty level with respect to patients anatomy,adequate depth of anaesthesia ,and unanticipated problems arising on last moment either patient or equipment related causing unexpected delays in intubation time.
hence to findout this in the present study, 60 adult patients comparable in age, sex, weight ,MPC and ASA status scheduled for elective surgeries under general anaesthesia were randomly allocated into two groups of 30 each. Explained written informed consent was obtained from all the patients .Baseline HR, SBP, DBP, MAP, Spo2 were recorded for all the patients. Both the groups received general anaesthesia with similar balanced anaesthesia technique (Injection fentanyl 2ug/kg intravenously , injection propofol 2-2.5mg/kg intravenously, injection rocuronium 1mg/kg intravenously). Tracheal intubation was performed using either intubating laryngeal mask airway or Macintosh laryngoscope.where conventional intubation with Macintosh laryngoscope finished within few seconds to couple of minute ,ILMA guided intubations aoften require multiple sequential steps theoratically demanding few extra time.
The intubation time, number of attempts required for successful intubation, haemodynamic changes and oro-pharyngo-laryngeal complications encountered during both the methods were recorded.
Intervention code [1] 285322 0
Treatment: Devices
Intervention code [2] 285350 0
Treatment: Other
Comparator / control treatment
Active controll "standard care'' , the comparator group underwent conventional direct laryngoscope guided intubation with use of Macintosh laryngoscope which is the second group or second arm of our study and by itself it is a standard care and routine practice for all those who receive general anaesthesia.
Control group
Active

Outcomes
Primary outcome [1] 287574 0
The intubation time
This will be assesed by use of a stop watch started and stopped at similar endpoints(timepoints) predecided at the start of the procedure and observations noted noted by an independent observer blinded from the details and nature of this study.
Timepoint [1] 287574 0
measured from removal of pre oxygenation mask till securing of endotracheal tube after confirmation of its correct placement
Primary outcome [2] 287575 0
number of intubation attempts and success rate
This will be judged by clinical assessment and charting the observations onto a data record sheetby an independent observer blinded from the details and nature of this study.
Timepoint [2] 287575 0
>2 attempts at intubation considered as failed attempt.
This will be judged by clinical assessment and charting the observations onto a data record sheetby an independent observer blinded from the details and nature of this study.
Primary outcome [3] 287576 0
Heart rate and Mean arterial blood Pressure.
This will be judged fromthe Multiparameter equipment displaying heart rate and invasive blood pressure values which will be entered in a data record sheet by an independent observer blinded from the details and nature of this study.
Timepoint [3] 287576 0
during ILMA or Macintosh laryngoscope placement
during Endotracheal tube(ETT) placement
during ILMA removal
every 1 min till 5 min post ETT placement
Secondary outcome [1] 298432 0
Oro-pharyngo-laryngeal complications
Eg:
1.oxygen saturation(Spo2):- judged by 'puloximeter device'
2.Dental trauma:- judged by clinical observation of dentition
3.Mucosal trauma:- will be judged by presence of blood stains on intubation device after the procedure
4.Oesophageal intubation:- judged both by clinical observation and by special device known as capnogram
5.Laryngospam:- judged by clinical observation
Timepoint [1] 298432 0
from start of the intubation technique till securing ETT

Eligibility
Key inclusion criteria
1.Patients scheduled for elective surgeries planned under general anaesthesia requiring oro-tracheal intubation.
2.ASA status I or II
3.Mallampati grading I and II
4.Body Mass Index (BMI)<40
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Age<18 and >55 years
2.ASA status III and above
3.Mallampatti Grading III and Above
4.Anticipated difficult intubation
5.H/O of active gastro-oesophageal reflux
6.Cardio respiratory or cerebrovascular disease
7.Taking long term medications affecting HR and BP
8.Morbid Obesity- BMI 40 and above
9.H/O of sore throat within last 10 days
10.Unwillingness to participate in the study (no Consent)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by self handpicking the similar looking envelopes containing a paper chit determining the group to which the patient is randomised.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4417 0
India
State/province [1] 4417 0
Maharashtra

Funding & Sponsors
Funding source category [1] 285678 0
Hospital
Name [1] 285678 0
MGIMS-Sevagram
Country [1] 285678 0
India
Primary sponsor type
Hospital
Name
MGIMS-Sevagram
Address
Mahatma gandhi Institute of Medical sciences-Sevagram,
POST CODE 442102,
Distt Wardha,
Maharashtra,
INDIA
Country
India
Secondary sponsor category [1] 284507 0
None
Name [1] 284507 0
None
Address [1] 284507 0
None
Country [1] 284507 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287666 0
MGIMS-Sevagram Institutional committee
Ethics committee address [1] 287666 0
Mahatma gandhi Institute of Medical sciences-Sevagram,
POST CODE 442102,
Distt Wardha,
Maharashtra,
INDIA
Ethics committee country [1] 287666 0
India
Date submitted for ethics approval [1] 287666 0
Approval date [1] 287666 0
06/08/2009
Ethics approval number [1] 287666 0
MGIMS/IEC/AUGUST/6/2009

Summary
Brief summary
A Comparative Study of "Overall efficacy and haemodynamic effects following blind oro-tracheal intubation with Intubating Laryngeal Mask Airway (ILMA) vs conventional direct laryngoscopy guided intubation with Macintosh laryngoscope in patients with normal airway undergoing elective surgery".
Background: Intubating laryngeal mask airway (ILMA)is a new device to guide blind Orotracheal intubation thus offering a new approach for endotracheal intubation and is expected to produce less sympathetically driven haemodynamic stress response.The available studies provide inconsistent results and wide subjective variations with respect to user. The purpose of this study was to assess overall efficacy ,haemodynamic advantage and complication rate with use of ILMA compared to conventional method of endotracheal intubation with use of Macintosh laryngoscope.
Method: The present randomized controlled study was conducted to compare the overall efficacy and haemodynamic effects following blind oro-tracheal intubation with ILMA vs conventional direct laryngoscopy guided intubation with Macintosh laryngoscope in patients with normal airways. 60 adult patients comparable in age, sex, weight ,MPC and ASA status scheduled for elective surgeries under general anaesthesia were randomly allocated into two groups of 30 each. Pre-anaesthetic checkup and routine pre operative investigations according to departmental protocol were done for all the patients. Explained written informed consent was obtained from all the patients .Baseline HR, SBP, DBP, MAP, Spo2 were recorded for all the patients. Both the groups received general anaesthesia with similar balanced anaesthesia technique (Inj fentanyl 2ug/kg, propofol 2-2.5mg/kg, rocuronium 1mg/kg). Tracheal intubation was performed using either intubating laryngeal mask airway or Macintosh laryngoscope.The intubation time, number of attempts required for successful intubation, haemodynamic changes and oro-pharyngo-laryngeal complications encountered during both the methods were recorded.
Results:Time to intubation was comparatively longer in the ILMA group than laryngoscopy group (152.46+26.06sec vs 34.9+7.59sec, P less than 0.05).The success rate of intubation was 100% in both the groups.Overall haemodynamic changes in both the groups were statistically comparable (P greater than 0.05) and ILMA appears to be offering no haemodynamic advantage over Macintosh laryngoscope. But when looked at individual steps of intubation it was seen that insertion of ILMA and passing of ETT through ILMA generates lesser pressor response compared to laryngoscopy and intubation with Macintosh laryngoscope(P less than 0.05).This haemodynamic advantage of ILMA however is lost at the time of its removal over ILMA-ETT where MAP of ILMA rises to become comparable with that of Laryngoscope group (maximum MAP with ILMA was 104.43+5.90, maximum MAP with Laryngoscope was 102.15+4.16, P greater than 0.05). All the changes in HR and MAP remained within acceptable 20% from the baseline values in both the groups and hence were clinically insignificant . The incidence of Oro-phayngo-laryngeal morbidity judged by desaturation, dental injury, mucosal trauma, oesophageal intubation and laryngospasm was rare and comparable amongst both the groups(P greater than 0.05).
Conclusion :Therefore in patients with normal airway blind intubation with ILMA is a successful and equally efficacious method without significant oro-pharyngo-laryngeal morbidity but offers no added haemodynamic advantage compared to conventional direct laryngoscopy with Macintosh laryngoscope . Thus ILMA may act as a suitable alternative to direct laryngoscopy for patients with normal airway undergoing elective surgeries which require tracheal intubation and general anaesthesia but its advantages in difficult airway cases needs to be further investigated where pressor response to direct laryngoscopy and intubation is proven to be deleterious
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34469 0
Address 34469 0
Country 34469 0
Phone 34469 0
Fax 34469 0
Email 34469 0
Contact person for public queries
Name 17716 0
Dr.Vijay sharma
Address 17716 0
Department of Anaesthesiology,
MGIMS-Sevagram,
At Post Code-442102,
District Wardha
Maharashtra
INDIA
Country 17716 0
India
Phone 17716 0
+91 7152 260031
Fax 17716 0
+91 7152 284333
Email 17716 0
[email protected]
Contact person for scientific queries
Name 8644 0
Dr.Vijay sharma
Address 8644 0
Department of Anaesthesiology,
MGIMS-Sevagram,
At post Code-442102,
District Wardha
Maharashtra
INDIA
Country 8644 0
India
Phone 8644 0
+91 7152 260031
Fax 8644 0
+91 7152 284333
Email 8644 0
[email protected]

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