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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

anaesthesia

intubation methods

Condition category

Condition code

Anaesthesiology

Anaesthetics

Respiratory

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]

Treatment: Devices

Intervention code [2]

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]

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]

measured from removal of pre oxygenation mask till securing of endotracheal tube after confirmation of its correct placement

Primary outcome [2]

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]

>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]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

India

State/province [1]

Maharashtra

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

MGIMS-Sevagram

Address [1]

Mahatma gandhi Institute of Medical sciences-Sevagram,
POST CODE 442102,
Distt Wardha,
Maharashtra,
INDIA

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

MGIMS-Sevagram Institutional committee

Ethics committee address [1]

Mahatma gandhi Institute of Medical sciences-Sevagram,
POST CODE 442102, 
Distt Wardha,
Maharashtra,
INDIA

Ethics committee country [1]

India

Date submitted for ethics approval [1]

Approval date [1]

06/08/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr.Vijay sharma

Address

Department of Anaesthesiology,
MGIMS-Sevagram,
At Post Code-442102,
District Wardha
Maharashtra
INDIA

Country

India

Phone

+91 7152 260031

Fax

+91 7152 284333

[email protected]

Contact person for scientific queries

Name

Dr.Vijay sharma

Address

Department of Anaesthesiology,
MGIMS-Sevagram,
At post Code-442102,
District Wardha
Maharashtra
INDIA

Country

India

Phone

+91 7152 260031

Fax

+91 7152 284333

[email protected]

No information has been provided regarding IPD availability

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Results publications and other study-related documents

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