CTRI Number |
CTRI/2018/08/015351 [Registered on: 16/08/2018] Trial Registered Retrospectively |
Last Modified On: |
12/08/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Crossover Trial |
Public Title of Study
|
Study comparing Laryngeal Views during laryngoscopy With Macintosh and Miller Larygoscope Blade At Different Operating Table Heights |
Scientific Title of Study
|
Comparative Study Of Laryngeal Views With Macintosh Vs Miller Larygoscope Blade At Different Operating Table Heights |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Kush Sharma |
Designation |
Post Graduate |
Affiliation |
Maulana Azad Medical College |
Address |
Anaesthesia Office,3rd floor, BLT Block, Bahadur Shah Zafar Marg, Delhi
Central DELHI 110002 India |
Phone |
09910823872 |
Fax |
|
Email |
qsh.sharma@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Kirti Nath Saxena |
Designation |
Director Professor |
Affiliation |
Maulana Azad Medical College |
Address |
Anaesthesia Office, 3rd floor, BL taneja Block, Maulana Azad Medical College, New Delhi
Central DELHI 110002 India |
Phone |
9910823872 |
Fax |
|
Email |
kirtinath@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Kush Sharma |
Designation |
Post Graduate |
Affiliation |
Maulana Azad Medical College |
Address |
Anaesthesia Office, 3rd floor, BL taneja Block, Maulana Azad Medical College, New Delhi
Central DELHI 110002 India |
Phone |
9910823872 |
Fax |
|
Email |
qsh.sharma@gmail.com |
|
Source of Monetary or Material Support
|
Maulana Azad Medical College, South Campus, Delhi University, Bahadurshah Zafar Marg, New Delhi 110002 |
|
Primary Sponsor
|
Name |
Maulana Azad Medical College |
Address |
2, Bahadurshah Jafar Marg, New Delhi 110002 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
KUSH SHARMA |
Lok Nayak Hospital |
1st floor, OT Block,Bahadur Shah Zafar Road, New Delhi, Delhi 110002 Central DELHI |
9910823872
qsh.sharma@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
PATIENTS FOR SURGERY UNDER GENERAL ANAESTHESIA, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Laryngeal views on direct laryngoscopy using Macintosh laryngoscope blade
|
Laryngeal views and head extension compared with the Miller laryngoscope blade |
Intervention |
Laryngeal views on direct laryngoscopy using miller laryngoscope blade |
Direct laryngoscopy performed using miller and macintosh laryngoscope blade and the laryngeal views compared with both blades at different operating table heights |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.Age group of 18-65 of either sex
2.ASA grading 1 and 2 excluding those with cardiovascular disease.
3.Mallampatti score of 1-2
4.Thyromental distance of more than 6 cms
5.Inter-incisor gap of more than 3 fingers.
6.Adequate neck flexion and extension: Using a Goniometer.
7.BMI less than 30kg/m 2
|
|
ExclusionCriteria |
Details |
1.Patients with congenital or acquired airway abnormalities
2.Patients with loose teeth or edentulous patients.
3.Patients with increased risk of aspiration
4.Pregnant females.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1.To evaluate and compare the best laryngeal view obtained using Miller and Macintosh blade with the operating table height at three difficult levels i.e. anaesthetist’s umbilicus, xiphoid process and nipples.
|
Best laryngeal views after 3 minutes |
|
Secondary Outcome
|
Outcome |
TimePoints |
To measure the degree of head extension achieved with the two laryngoscope blades at the three above mentioned positions of the operating table height.
|
3 minutes |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
22/07/2015 |
Date of Study Completion (India) |
04/05/2016 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Kitamura Y, Isono S, Suzuki N, Sato Y, Nishino T. Dynamic interaction of craniofacial structures during head positioning and direct laryngoscopy in anaesthetized patients with and without difficult laryngoscopy. Anaesthesiology 2007; 107: 875-83
. Benumof JL. Difficult laryngoscopy: Obtaining the best view (Editorial). Can J Anaesth 1994; 41: 361–5
. Achen B, Terblanche OC, Finucane BT. View of the larynx obtained using the Miller blade and paraglossal approach, compared to that with the Macintosh blade. Anaes Intensive Care 2008; 36: 717-21
. Heath ML. Stature of anaesthetic personnel and positioning of patients. Br J Anaesth 1998; 80: 579-80
. Lee HC, Yun MJ, Hwang JW, Na HS, Kim DH, Park JY. Higher operating tables provide better laryngeal views for tracheal intubation. Br J Anaesth 2014; 112(4): 749-55
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Establishment of clear glottic visualization is of great significance for successful tracheal intubation. The aim of direct laryngoscopy is to visualize the vocal cords through the anatomically curved, oropharyngolaryngeal space. When laryngoscopy is difficult with the curved blade, use of a straight type may help to achieve adequate laryngeal visualization. There have been few studies of correlation between the operating table height and the quality of laryngeal view during direct laryngoscopic intubation. It has been suggested. A study done using Macintosh laryngoscope blade validated that higher operating tables, with the patient’s forehead at either xiphoid process or nipple level of the anaesthetist can provide better laryngeal views during tracheal intubation, however, the patient’s head and neck posture during laryngoscopy was neither controlled nor monitored. There is no study comparing the laryngeal views obtained at different table heights using a straight blade laryngoscope. In this study, we compared the laryngeal views obtained using Miller and Macintosh blades at three different table heights by keeping a fixed head position. Additionally we also compared the degree of head extension achieved during the use of the two laryngoscope blades at the three different operating table heights. METHODS: A randomized controlled study was undertaken to evaluate and compare the laryngeal view obtained with the use of Miller and Macintosh blade at operating table height with the patient’s forehead at three different levels i.e. anaesthetist’s umbilicus, xiphoid process and nipples. The degree of head extension achieved with the two laryngoscope blades at the three above mentioned positions of the operating table height was also measured. 105 ASA I/II patients of either sex, between the age group of 18-65 years, with no anticipated difficulty in laryngoscopy and intubation who were scheduled to undergo elective surgery under general anaesthesia were enrolled in the study. Patients were randomized to one of the three predetermined operating table while using the same 7cm incompressible pillow below the occiput. Randomization was also done for the blade first used for laryngoscopy. The quantitative variables were expressed as mean±SD and compared using Mann-Whitney test while qualitative variables were expressed as percentages and compared using Chi-Square / Fisher’s exact test. Results: With the use of Miller blade, CL grade of 1 was obtained in 9.5% of the study population. Among the patients with operating table height at nipple level with Miller blade, 25.7% were found to have CL grade 1, 2.9% at umbilicus and 0% at xiphoid process. Using Pearson Chi square test, the p value was found to be .002. This difference was found to be statistically significant. 10.5% patients had CL grade 3 with Miller blade. 14.3% of the patients at level of umbilicus, 11.4% at xiphoid and 5.7 % at nipple level exhibited CL grade 3. None of the patients in any of the study groups were found to have CL grade 4. With the use of Macintosh blade, CL grade of 1 was obtained in 33.3% of the study population. Among the patients with operating table height at the umbilicus with Macintosh blade, 42.9% were found to have CL grade 1, 37.1% at Nipple and 20% at xiphoid process. Using Pearson Chi square test the p-vale was found to be .264. The difference was not found to be statistically significant. Only 2 (1.9%) patients were found to have CL grade 3, 1 at Nipple level and 1 at xiphoid. Comparison of percentage distribution of CL grades with the use of Miller and Macintosh at different operating table heights, Macintosh laryngoscope blade provided a higher percentage of CL grade 1 across all table heights. On assessing the secondary parameter, mean angle of head extension of 7.102˚ was found with Macintosh blade and 7.899˚ with Miller blade. With the use of Macintosh blade, Mean head extension was compared at the three table heights. Using Kruskal-Wallis test, the p-value was found to be 0.062 which was statistically non-significant. Using Kruskal-Wallis test for mean head extension with the use of Miller blade, the p-value was found to be 0.011. The difference in the mean degree of head extension found at different table heights with Miller Blade was found to be statistically significant. Comparing the different operating table heights, best laryngeal views were obtained at the level of anaesthesiologist’s nipple with CL grade 1 found in 31.43% of the laryngoscopies followed by umbilicus (22.86%) and the minimum of 10% found at the Xiphoid level. However assessment of the degree of head extension revealed that laryngoscopy was possible with the least head extension at the level of umbilicus with mean head extension of 6.5145˚ followed by 7.892˚ at xiphoid level. Maximum head extension was found at nipple level with a mean head extension of 8.1015˚ |