TITLE
“A COMPARATIVE STUDY OF ENDOTRACHEAL INTUBATION WITH WIRE-REINFORCED SILICONE ENDOTRACHEAL TUBE VERSUS CONVENTIONAL POLYVINYL CHLORIDE TRACHEAL TUBE THROUGH THE INTUBATING LARYNGEAL MASK AIRWAY (LMA-FASTRACH)”
NAME OF THE INVESTIGATOR
DR. SHAJI T V
POSTGRADUATE IN MD ANAESTHESIOLOGY
A.J INSTITUTE OF MEDICAL SCIENCES, MANGALORE-575004
NAME OF THE GUIDE
DR.KARUNAKARA ADAPPA K.
PROFESSOR AND HEAD OF THE DEPARTMENT
DEPT OF ANAESTHESIOLOGY, A.J INSTITUTE OF MEDICAL SCIENCES, MANGALORE-575004
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE
Annexure –II
SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / NAME OF THE CANDIDATE / DR.SHAJI T VPOSTGRADUATE STUDENT
DEPARTMENT OF ANAESTHESIOLOGY
A.J. INSTITUTE OF MEDICAL SCIENCES, MANGALORE-575004
2 / NAME OF THE INSTITUTION / A.J. INSTITUTE OF MEDICAL SCIENCES AND RESEARCH,KUNTIKANA,MANGALORE -575004
3 / COURSE OF STUDY AND SUBJECT / MD, ANAESTHESIOLOGY.
4 / DATE OF ADMISSION TO COURSE / 05th JULY 2013.
5 / TITLE OF THE TOPIC / “A comparative study of endotracheal intubation withwire-reinforced silicone endotracheal tube versus conventional polyvinyl chloride tracheal tube through the intubating laryngeal mask airway(LMA-Fastrach)”
6 / BRIEF RESUME OF INTENDED WORK:
6.1. NEED FOR THE STUDY:
The intubating laryngeal mask airway (ILM) is an airway device that facilitates tracheal intubation without laryngoscopy. Intubating laryngeal mask airway (LMA) isan anatomically curved, soft silicone-coated, metal tube with a guiding handle.
The LMA-Fastrach™ in addition to ventilation of lung also known to provide a superior conduit for blind or fiberoptically guided tracheal intubationin difficult airway cases.
A dedicated wire-reinforced silicone (WRS) endotracheal tube (ETT) is advocated for intubation through the LMA-Fastrach TM. The unique characteristics of this tube are the straight alignment, wire reinforcement, and presence of a conical Touhy-like tip, which is less traumatic than conventional ETT. However, the low volume, high-pressure cuff of this tube makes it less suitable for prolonged use. Also, it is very expensive and not so easily available. Moreover, wire reinforcement may be disadvantageous, as ventilation may be hampered due to distortion of the lumen if the patient bites on the tube. A conventional Polyvinylchloride (PVC) ETT besides being disposable is cheaper, easily available, and has high volume low pressure cuff, which is more suitable for prolonged ventilation.
However, with PVC ETT, there are concerns of decreased chances of entry into the glottis and airway trauma, due to its relative stiffness and also because the tip points anteriorly on emergence from the ILMA, partly which can be rectified by warming the tube. Despite these concerns, the conventional PVC tube has been used successfully for tracheal intubation through the ILMA [1].
The present study is designed to compare the ease of insertion of conventional PVC ET tube through the ILMA in comparison withthe siliconeET tubeto evaluate the feasibility of using the PVC ET tube in ILMA.
6.2.REVIEW OF LITERATURE:
Sharma et al. studied the number of attempts, time taken, and manoeuvres employed to accomplish tracheal intubations. Patients were randomly allocated to one of the two groups: Group I (n = 100): Cuffed PVC tube and group II (n = 100); LMA Fastrach WRS ETT by sealed envelope method. In group I, 96% patients were successfully intubated (90% in the 1st attempt, 5% in the 2nd attempt, and 1% in the 3rd attempt). In group II, the success rate was 97%(95% in 1st attempt and 2% in 2nd attempt). Mean time for successful tracheal intubation was significantly higher in group I than in group II (14.7s and 10.04s, respectively). The adjustment manoeuvres were significantly higher in group I (28%) than in group II (3%)[1].
In a study by Brain et al. in 1997, tracheal intubation with silicone tube, was successful in 149 of 150 (99.3%) patients. 75(50%) at the first attempt, 28 (19%) required one adjusting manoeuvre, 21(14%) required two, 18 (12%) required three and seven (5%) required four attempts. They used different manoeuvres to achieve high success rate, which include the up and down manoeveuvre, optimizing the airway, change of size, raising the mask upwards, partial withdrawal, rotating the bevel, adjusting head-neck position, and adding air to the cuff [2].
Ferson et al. in 2001, studied blind intubation through the LMA-Fastrach™ using non-disposable, silicone endotracheal tubes. It was attempted in 200 cases and was successful in 193 (96.5%). Blind intubation was achieved on the first attempt in 151 cases (75.5%). On the remaining blind intubation attempts, successful intubation was achieved on the second, third, fourth, and fifth attempts in 28 (14.0%), 7 (3.5%), 5 (2.5%), and 2 cases (1.0%), respectively. In seven cases (3.5%), blind intubation through the LMA- Fastrach™ failed after five attempts, and fiberoptically guided intubation was successful on the first attempt[3].
Kundra et al.in 2004evaluated the success rate of blind tracheal intubation through the ILMA by using the LMA Fastrach™ silicone wire-reinforced tracheal tube (FTST), the Rusch polyvinyl chloride tube (PVCT), and the Rusch latex armored tube (LAT). Blind tracheal intubation through the ILMA was successful in 96% of patients with a maximum of 2 attempts, and more frequent success was demonstrated in Groups PVCT and FTST when compared with Group LAT. Overall, 74.6% of patients had successful tracheal intubation on the first attempt. Tracheal intubation was accomplished more frequently in Groups PVCT and FTST (86%) than in Group LAT (52%). This study demonstrates an overall success rate with the PVCT that is similar to that with the FTST (96%) [4].
Joo and Rose, in 1998, compared tracheal intubation using direct laryngoscopy, ILMA with fiberoptic guidance (ILMA-FOB) and ILMA without fiberoptic guidance (ILMA-Blind) using PVC tracheal tube. They studied 30 patients in each group and success rate with ILMA blind technique was 97% [5].
Kihara et al. in 2000 compared tracheal intubation with the Macintosh Laryngoscope versus blind intubation via the ILM using a straight, silicone tube; In their study, ILM intubation was successful in 94%. The average time for intubation was 57 s. Incidence of mucosal injury and esophageal intubation was higher (26%), whereas incidence of sore throat and hoarseness were similar among groups[6].
Kapila et al. (1995) achieved a 95% success rate with a Portex PVC tube. They conducted a study on 100 ASA I/II patients scheduled for elective surgeries. 72% were intubated at the 1st attempt with no manipulation, 21% with 2 or more attempts (manipulation) [7].
Shetty et al.in 2005, studied Intubating Laryngeal Mask Airway (ILMA) for blind endotracheal intubation in patients undergoing Spine or Orthopaedic Surgery under general anaesthesia. The study was conducted on 75 ASA I/II patient. In their study they were able to intubate 96% of the patients via ILMA. The mean time for successful intubation via the ILMA was 19.08s [8].
6.3. OBJECTIVES OF THE STUDY
- To evaluate and compare the ease of intubation between groups I and II.
- To compare the complications(sore throat,Hoarseness, evidence of trauma and esophageal intubation), if any.
7 / MATERIALS AND METHODS:
7.1 (a) SOURCE OF DATA:
Patients aged between 18-60 years, ASA grade I/II posted for elective surgeries under general anaesthesia in A.J.I.M.S Hospital, Mangalore between December 2013 and May 2015.
(b)STUDY DESIGN:
Prospective study by randomised sampling method.
(c)INCLUSION CRITERIA.
1. Patients belonging to ASA grade I and II scheduled for elective surgery under general anaesthesia.
2. Mallampatti grade I and II patients.
3. Patients of either sex, between the age group 18-60 years.
4. Interincissor distancesmore than 2 cms on pre-anesthetic assessment.
5. Thyro-mental distance greater than 6 cms.
(d) EXLUSION CRITERIA.
1. Patients belonging to ASA grade III or IV.
2. Patient refusal.
3. Patients with loose dentures.
4. Patients with enlarged thyroid gland.
5. Patients with hypertrophied tonsils (grade 3 and 4).
6. Patients with morbid obesity.
7. Patients with respiratory tract pathology.
8. Patients with previous upper gastrointestinal (GI) surgery like gastroeseophageal reflux disease or Hiatus Hernia.
7.2. METHOD OF COLLECTION OF DATA:
SELECTION CRITERIA:
Written informed consent will be taken from patients, for willingness to participate in the study, for pre-anesthetic assessment, intubation and postoperative evaluation of any complications.
60 patients aged between 18-60 years posted for elective surgeries under general anaesthesia, in A.J.I.M.S, Mangalore, will be divided into two groups (Group I and Group II) of 30 patients each,by random sampling method.
- Group I: will be intubated using wire enforced silicone endotracheal tube through intubating laryngeal mask airway (LMA-Fastrach).
- Group II: will be intubated using Polyvinyl chloride tube through the intubating laryngeal mask airway (LMA-Fastrach).
: Size 3 – for patients weighing < 50 kgs
: Size 4 – for patients weighing between 50 and70kgs
All patients will be kept NPO overnight. Tab.Ranitdine 150mgs will be given previous night and the morning of surgery. In the operation theatrefollowing monitors like pulse oximeter, non-invasive blood pressure, ECG leads and ETCO2will be connected. IV line secured and fluid DNS initiated. Patient will be premedicated with Inj.Glycopyrrolate (0.005mcg/kg) I V, Inj.Fentanyl (1mcg/kg) I.V. Patients are preoxygenated with 100% Oxygen for 3 minutes. Induced with Inj.Propofol (2 mg/kg)I.V. and Inj.Vecuronium (0.1mg/kg) I.V.
After 3 minutes, when patient is fully relaxed an appropriate sized ILMA will be inserted with cuff deflated, after which the cuff is inflated with air, up to 20ml for size 3and 30ml for size 4. Correct placement is confirmed by the ability to ventilate without leak at an airway pressure of 20 mm Hg. Then cuff is inflated and a square wave capnograph tracing during gentle ventilation is noted. Ifpatient cannot be ventilated, adjustments like pulling the handle back towards the intubator(extension manoeuvre), withdrawal of the ILMA by 5 cms with the cuff inflated followed by reinsertion(up-down manoeuvre), ventilation commenced and the position of the ILM adjusted until the optimal seal, as determined by audible leak with the expiratory valve closed was obtained(optimization manoeuvre), and flexing the neck and extending the head(head-neck manoeuvre), rotation in the sagittal plane, or lifting away from the posterior wall(Chandy manoeuvre) are done. Thereafter, a well-lubricated size 7.0 or 7.5mm ID cuffed, WRS ETT or pre-warmed PVC at 60C for 1minute in sterile water, according to the group assignment, is passed through the metal tube of the ILMA. The tube is inserted till 16cm depth. It is then advanced gently in to the trachea without applying undue force, the cuff is inflatedand the ETT connected to Bain circuit. Correct tube placement is confirmed by the presence of bilateral breath soundson auscultation and capnography. The ILMA is then deflated and removed using the designed stabilizing rod to maintain the tube in place, which is then reconnected to the Bain circuit. Intubation failure is recorded if intubation was not accomplished in 3 attempts, in which case alternate method of securing the airway using direct laryngoscopy will be used.
Patient is maintained on O2+N2O + Halothane (0.2%) + Inj.Vecuronium, intermittent i v bolus.
Post operatively patients will be observed/monitored over 24 hours and any complications like hoarseness, sore throat and airway trauma will be noted inevery patient.
Parameters to be studied
1)Ease of intubation by i) Number of attempts
ii) Time taken for intubation (is the time from disconnection of breathing circuit from the ILMA to the time to successful tracheal intubation as confirmed by the presence of bilateral breath sounds and capnography).
iii) Manoeuvre employed to accomplish tracheal intubation
2) Overall success rate for oxygenation and ventilation with the ILMA as a primary airway, success rate for tracheal intubation using the ILMA.
StatisticalAnalysis:
Statistical analysis for demographics is compared using Student’s ‘T’ test. Categorical data are analysed using Chi-Square test or as appropriate.
7.3 Does the study require any investigation or interventions to be conducted on patients or other human or animals? If so, please describe briefly.
YES. Pre-anesthetic routine investigation as indicated.
7.4 Has the ethical clearance obtained from your institution?
Yes, ethical clearance has been obtained.
8 / LIST OF REFERENCES:
1: Sharma MU, Gombar S, Gombar KK, Singh B, Bhatia N. Endotracheal intubation
through the intubating laryngeal mask airway (LMA-Fastrach™): A randomized study
of LMA- Fastrach™ wire-reinforced silicone endotracheal tube versus conventional
polyvinyl chloride tracheal tube. Indian J Anaesth. 2013; 57:19-24.
2: Brain AI, Verghese C, Addy EV, Kapila A, Brimacombe J. The intubatinglaryngeal mask. II: A preliminary clinical report of a new means of intubatingthe trachea. Br J Anaesth. 1997;79(6):704-9
3. Ferson DZ, Rosenblatt WH, Johansen MJ, Osborn I, Ovassapian A. Use of the
intubating LMA-Fastrach in 254 patients with difficult-to-manage airways.
Anesthesiology. 2001;95(5):1175-81
4.Kundra P, Sujata N, Ravishankar M. Conventional tracheal tubes for intubation
through the intubating laryngeal mask airway. Anesth Analg. 2005; 100(1):284-8.
5. Joo HS, Rose DK. The intubating laryngeal mask airway with and without
fiberoptic guidance. Anesth Analg. 1999; 88(3):662-6.
6. Kihara S, Watanabe S, Taguchi N, Suga A, Brimacombe JR. A comparison of blind
and lightwand-guided tracheal intubation through the intubating laryngeal mask.
Anaesthesia. 2000; 55(5):427-31.
7. Kapila A, Addy EV, Verghese C, Brain AI. The intubating laryngeal mask airway:
an initial assessment of performance. Br J Anaesth. 1997;79(6):710-3.
8.A Shetty, P Shroff, L Chaudhari, R Prashanth. “Clinical Appraisal of Intubating Laryngeal Mask Airway (ILMA) for blind endotracheal intubation in the patients undergoing Spine or Orthopaedic Surgery under General Anaesthesia”. The Internet Journal of Anesthesiology. 2005 Volume 10 Number 2.
9 / SIGNATURE OF CANDIDATE:
10 / REMARKS OF THE GUIDE:
Securing and maintenance of a patent airway is the fundamental requirement of safe anesthesia. Laryngeal mask airway(LMA), a supraglottic airway device, is a breakthrough development in the management of difficult airway. LMA can be used as a sole airway device as well as a conduit to endotracheal intubation. In this “comparative study of endotracheal intubation with wire-reinforced silicone endotracheal tube versus conventional polyvinyl chloride tracheal tube through the intubating laryngeal mask airway”is done in normal airway patients.
This study will be a beacon in the management of difficult airway patients with regular PVC ET tube.
11 / NAME AND DESIGNATION OF:
11.1. GUIDE
DR.KARUNAKARA ADAPPA K.
PROFESSOR AND HEAD OF THE DEPARTMENT
DEPT OF ANAESTHESIOLOGY,A.J INSTITUTE OF MEDICAL SCIENCES, MANGALORE-575004.11.2. SIGNATURE:
11.3. COGUIDE:
11.4. SIGNATURE:
11.5. HEAD OF THE OF THE DEPARTMENT:
DR.KARUNAKARA ADAPPA K.
PROFESSOR AND HEAD OF THE DEPARTMENT
DEPT OF ANAESTHESIOLOGY, A.J .INSTITUTE OF MEDICAL SCIENCES, MANGALORE-57500411.6. SIGNATURE:
12 / 12.1.REMARKS OF THE CHAIRMAN AND PRINCIPAL:
12.2.SIGNATURE OF THE PRINCIPAL:
1