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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  
nil 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  all patient undergoing general anaesthesia above 18 years of age,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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