Tracheal Intubation Morbidity Clinical Trial
Official title:
Comparison of Visualisation of Laryngeal Inlet and Ease of Intubation With Different Laryngoscope Blades.
Orotracheal intubation the commonest method used to secure and maintain airway during
anaesthesia. A variety of methods are available for orotracheal intubation such as digital
or tactile method, use of lighted orotracheal intubating stylet, use of intubating LMA
(which is becoming increasing popular, particularly in cased of anticipated difficult
intubation), fibreoptic endoscopic orotracheal intubation (also used when a difficulty is
predicted), and conventional and most common method, direct laryngoscopy. Orotracheal
intubation is most commonly achieved after visualization of laryngeal inlet with direct
laryngoscopy following induction of general anaesthesia and muscle relaxation achieved by
administration of a muscle relaxant.
Due to the hazards seen with failed intubation, anaesthetists are also on the lookout for
techniques which will improve visualization of the laryngeal inlet, i.e. glottis. View
obtained during laryngoscopy can be classified in a variety of ways such as Cormack Lehane
grading, the percentage of glottic opening (POGO Score)Literature suggests that straight
blade gives better glottic visualization while tracheal intubation is easier with the curved
blade. We therefore wanted to compare the Macintosh and Miller laryngoscope blades in terms
of visualization of Laryngeal inlet and ease of intubation in patients with normal predicted
intubation. We also compared the McCoy blade, a modified curved blade, and the Trueview
Laryngoscope, which incorporates a prism in a straight blade, for glottic view and ease of
intubation.
This prospective observational study was conducted after obtaining approval from the
Institutional Review board of our institute. One hundred and twenty adult patients were
included who had given written informed consent. These patients were ASA I or II, between
18-70 yrs of age, were undergoing elective oncosurgery procedure under general anaesthesia
requiring endotracheal intubation. Patinets were excluded if they refused consent, were
pregnant, had potential difficult mask ventilation and /or anticipated difficult intubation
or had pathology in neck, upper respiratory tract and upper alimentary tract. A detailed
routine pre-anaesthetic check-up was performed and routine laboratory investigations were
done. The patients were randomly divided in four groups of 30 each per laryngoscope blade.
Group 1: Macintosh Group Group 2: McCoy's Group Group 3 Miller Group and Group 4: TrueView
Group. : included 30 patients.
In the operating room, patients' medical history was again confirmed in brief before
subjecting the patient to anaesthesia. Demographic data such as age, sex and weight of the
patient was noted. Pulse oximeter, electrocardiograph, capnography and automated
non-invasive blood pressure were used for monitoring. Airway assessment was done clinically
using Samsung and Young's modification of the Mallampati classification for oropharyngeal
view. The patient was asked to assume sitting position, open the mouth maximally, and
protrude the tongue but not to phonate. Visibility of the oral and pharyngeal structures was
then classified by an observer sitting at the same level as the patient.
Class I: Soft palate,fauces,uvula,pillars visible Class II: Soft palate,fauces,portion of
uvula visible Class III: Soft palate,base of uvula visible Class IV : Only hard palate
visible A Doughnut-shaped pillow and hard sponge square pillow, totalling about 7 cm in
height, was placed under the head of the patient. The patient was preoxygenated with 100%
oxygen for three minutes. Anaesthesia was then induced with 1-3 mg/kg of Propofol or
thiopentone sodium 5 mg/kg, fentanyl 2 µg/kg. Feasibility of ventilation with a face mask
was checked prior to injection of non-depolarising muscle relaxant. After ventilation was
confirmed a vecuronium was administered and the patient was ventilated with isoflurane
0.5-1% in a 50:50 mixture of O2 and N2O for 3 minutes then ventilated for 1 minute with 100%
O2. Then laryngoscopy and tracheal intubation accomplished with the selected laryngoscope
blade. The laryngoscopy and intubation were carried out by a single anaesthesiologist who
had trained with all laryngoscope blades till he had obtained sufficient familiarity all
four laryngoscope blades. We studied following aspects during tracheal intubation.
Visualization of laryngeal inlet: This was graded using Cormack Lehane Grades:
Grade 1: complete glottis visible Grade 2: anterior glottis not seen Grade 3: epiglottis
seen but not glottis Grade 4: epiglottis not seen
Ease of intubation: This was graded as follows:
Grade 1: Intubation easy Grade 2: Intubation requiring an increased anterior lifting force
and assistance to pull the right corner of the mouth upwards to increase space Grade 3:
Intubation requiring multiple attempts and a curved stylet Grade 4: Failure to intubate with
the assigned laryngoscope Number of attempts: We noted the number of attempts needed for
intubation with that particular blade in each patient.
Requirement of external laryngeal manipulation: Classified as Grade 1: No requirement of
external laryngeal manipulations and Grade 2: Requirement of external laryngeal
manipulation.
Statistical analysis: Demographic data, Mallampatti Classification and other variables were
compared using the Chi Square test. A p value of > 0.05 was taken to assume statistical
significance.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01118533 -
Impact of Blades Used for Scheduled Orotracheal Intubation on Postoperative Sore Throat
|
N/A | |
Recruiting |
NCT05542823 -
Effect of Cuff Pressure of Endotracheal Tube on POST
|
||
Not yet recruiting |
NCT05899270 -
3D-printed Reconstruction Automated Matching System Predicts Size of Double-lumen Tube: a Prospective Double-blinded Randomized Controlled Trial
|
N/A | |
Completed |
NCT02966392 -
Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections
|
N/A | |
Completed |
NCT03304431 -
Evaluation of the Effect of 10% Lidocaine Spray Undergoing Coronary Artery Bypass Graft Operation
|
Phase 4 | |
Withdrawn |
NCT05016076 -
Multi-Strategy Intervention for Anesthesia Care of Obese Patients A Factorial Randomized Controlled Trial
|
N/A | |
Completed |
NCT01116999 -
Retrograde Light Target Tracheal Intubation Technique:Clinical Comparison With Direct Pharyngoscopic Tracheal Intubation
|
N/A | |
Recruiting |
NCT05173220 -
Impact of the Bougie on the Prehospital Setting Intubation Quality.
|
||
Recruiting |
NCT03471884 -
Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection
|
N/A | |
Completed |
NCT01289769 -
The Effect of Dexmedetomidine on Hemodynamic Response During Double Lumen Endotracheal Intubation
|
Phase 2 | |
Recruiting |
NCT03486171 -
Tracheal Intubation and Prehospital Emergency Setting
|
||
Recruiting |
NCT05451953 -
Providing Oxygen During Intubation in the NICU Trial
|
N/A | |
Terminated |
NCT02495259 -
Comparison of Double Lumen Tube Placement Techniques
|
N/A | |
Completed |
NCT01367093 -
French and EuRopean Outcome Registry in Intensive Care Unit
|
N/A | |
Completed |
NCT01474252 -
Comparison of Intubation Duration Between Rapid Sequence Intubation (RSI) Technique and Non-RSI Technique
|
Phase 4 | |
Completed |
NCT04948359 -
Determining Optimal Cuff Volume in Pediatric Patients
|
||
Completed |
NCT05614414 -
Postoperative Sore Throat: Interest of the Videolaryngoscope
|
N/A | |
Recruiting |
NCT02671877 -
Preoperative Fibroscopy as a Predictor of the Difficulty of Laryngoscopy and Intubation
|
N/A | |
Completed |
NCT01215422 -
Success of Pediatric Anesthesiologists in Learning to Use Videolaryngoscopes
|
Phase 3 | |
Completed |
NCT03747250 -
Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia
|
N/A |