CTRI Number |
CTRI/2017/11/010602 [Registered on: 23/11/2017] Trial Registered Retrospectively |
Last Modified On: |
22/11/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Anaesthesia assessment |
Scientific Title of Study
|
Evaluation of Upper Lip Bite Test and Thyromental Height in
Predicting difficult Laryngoscopy – A Prospective
Observational Study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Alpesh Chhaganlal Bhanushali |
Designation |
DA, DNB Resident |
Affiliation |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute |
Address |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute,
Department of Anaesthesia,
Rao Saheb Achutrao, Patwardhan Marg, Four Bunglows, Andheri West, Mumbai, Maharashtra 400053.
Mumbai (Suburban) MAHARASHTRA 400053 India |
Phone |
9913470608 |
Fax |
|
Email |
dr.bhanushalialpesh@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Aparna Date |
Designation |
Consultant |
Affiliation |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute |
Address |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute,
Department of Anaesthesia,
Rao Saheb Achutrao, Patwardhan Marg, Four Bunglows, Andheri West, Mumbai, Maharashtra 400053
Mumbai MAHARASHTRA 400053 India |
Phone |
09324599577 |
Fax |
|
Email |
aparnadate@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Alpesh Chhaganlal Bhanushali |
Designation |
DA, DNB Resident |
Affiliation |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute |
Address |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute,
Department of Anaesthesia,
Rao Saheb Achutrao, Patwardhan Marg, Four Bunglows, Andheri West, Mumbai, Maharashtra 400053
Mumbai MAHARASHTRA 400053 India |
Phone |
9913470608 |
Fax |
|
Email |
dr.bhanushalialpesh@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Kokilaben Dhirubhai Ambani Hospital Medical Research Institute |
Address |
Rao Saheb Achutrao, Patwardhan Marg, Four Bunglows, Andheri West, Mumbai, Maharashtra 400053 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
Institutional Scientific Ethics Board ISEB |
Rao Saheb Achutrao, Patwardhan Marg, Four Bunglows, Andheri West, Mumbai, Maharashtra 400053. |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Alpesh C Bhanushali |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute |
Department of Anaesthesia,
Recovery room no-1,fifth floor,
Rao Saheb Achutrao, Patwardhan Marg, Four Bunglows, Andheri West, Mumbai, Maharashtra 400053 Mumbai (Suburban) MAHARASHTRA |
9913470608
dr.bhanushalialpesh@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Scientific & Ethics Board (ISEB) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
all patient undergoing general anaesthesia above 18 years of age, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Elective surgery under General anaesthesia with
endotracheal intubation. |
|
ExclusionCriteria |
Details |
1] Uncooperative patients, altered level of consciousness.
2] Unable to follow commands.
3] Pregnancy.
4] Emergency surgery. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To assess the difficulty of laryngoscopy on the basis of Thyromental height and Upper
lip bite test among the study cases |
after 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To compare the diagnostic sensitivity, specificity, positive predictive value and
negative predictive value of Thyromental height and Upper lip bite test in
predicting difficult intubation based on the Cormack and Lehane (CL) grading
on direct laryngoscopy.
2. To find out the predictivity of difficulty in both test together on the basis of
sensitivity, specificity, positive predictive value and negative predictive value. |
6 month |
|
Target Sample Size
|
Total Sample Size="109" Sample Size from India="109"
Final Enrollment numbers achieved (Total)= "109"
Final Enrollment numbers achieved (India)="109" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/04/2016 |
Date of Study Completion (India) |
30/11/2016 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="10" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
no publication |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Introduction: The significance of difficult or failed tracheal intubation is well recognized as a major cause of morbidity and mortality in anaesthetic practice. The importance of preoperative prediction of a difficult airway is obvious from the fact that 85% of all mistakes regarding airway management result in permanent cerebral damage and up to 30% of all anaesthetic deaths can be attributed to the management of difficult airways. Study procedure: We conducted a prospective observational study to evaluate Upper lip bite test(ULBT) and Thyromental height(TMHT) in predicting difficult laryngoscopy. After ethical committee approval, the study was conducted on 109 patients satisfying the inclusion and exclusion criteria. Patients included in the study underwent a routine pre anaesthetic check-up and routine preoperative investigations and investigations relevant to the surgery were obtained. Age, gender, weight, BMI, Medical history and ASA physical status of all patients were recorded. Preoperative assessment included airway assessment by Modified Mallampati Test(MMT), Upper Lip Bite Test(ULBT) and Thyromental height test(TMHT) and the findings were recorded by the principal investigator who was not involved in doing laryngoscopy of the subjects. On the day of surgery, it was confirmed that patients had fasted for at least 6 hours prior to surgery. After being taken in the operation theatre, routine institutional protocol was followed for general anaesthesia. After the induction of anaesthesia, the patient’s head and neck were kept in sniffing position, laryngoscopy was done using Macintosh laryngoscope with blade no 3 or 4 depending upon personal preferences by an senior anaesthesiologist with at least 2 years of experience. Glottic view was graded without any external pressure or other manoeuvres applied according to the Cormack and Lehane(CL) grading and the reading noted in anaesthesia sheet. CL grade 3 and 4 were considered as difficult intubation. Result summary: In this study, using MMT there were 1(0.9%) true positive; 5(4.6%) false positive; 15(13.8%) false negative and 88 (80.7%) true negatives. The sensitivity of MMT was found to be 6.25%%. The specificity was 94.62%, positive predictive value was 16.67% and the negative predictive value was 85.43%. The accuracy of MMT was 81.65% in this study. With ULBT, true positives were 3(2.7%), false positive were 2(1.8%), true negatives were 91(83.4%) and false negative were 13(11.9%) respectively. The sensitivity, specificity, positive predictive value and negative predictive value and was 18.75%, 97.85%, 60.0% and 87.5% respectively. The accuracy of ULBT in this study was found to be 86.23%. With TMHT, true positives were 13(11.9%), false positives were NIL, true negatives were 93(85.3%) and false negatives were 3(2.8%) respectively. The sensitivity of TMHT test was found to be 81.25% and specificity was found to be 100%. Positive predictive value was found to be 100%, negative predictive value was 96.87% and accuracy was 90.62% in our study. All the validity parameters for TMHT were found to be superior to MMT and ULBT and were statistically significant as per Mc Nemar’s test. Combining the ULBT and TMHT was of statistical significance than that of ULBT alone. Also combination of two test had the added clinical advantages of both the tests. Also, both the tests have high negative predictive value (87.5% for ULBT and 96.87% for TMHT) thus stressing the fact that both these tests can be good predictors of easy intubation. Conclusion: Thus, our study suggests that TMHT is a better predictor of difficult intubation as compared to ULBT and MMT. Combination of ULBT and TMHT don’t have statically significant than the TMHT alone. |