None listed
Conditions
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
Interventions
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 gu
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.
Sponsors
MGIMS-Sevagram
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
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
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)
Outcome results
None listed