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CTRI Number  CTRI/2022/11/047014 [Registered on: 03/11/2022] Trial Registered Prospectively
Last Modified On: 23/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   case series study 
Study Design  Other 
Public Title of Study   Assessing patients airway before surgery under general anaesthesia by asking set of questions  
Scientific Title of Study   "Assessment of perioperative difficult airway using STOP-BANG questionnaire among undiagnosed obstructive sleep apnea patients undergoing elective surgery under general anaesthesia": A hospital based case series study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivanand Y Hulakund  
Designation  Professor and Head of Department  
Affiliation  S N Medical college and HSK hospital and Research centre. 
Address  Department of Anaesthesiology, S N Medical college, Navanagar, Bagalkot, Karnataka , 587102.
Navanagar,Bagalkot, karnataka,587102
Bagalkot
KARNATAKA
587102
India 
Phone  9901098533  
Fax    
Email  hulkunds@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivanand Y Hulakund  
Designation  Professor and Head of Department  
Affiliation  S N Medical college and HSK hospital and Research centre. 
Address  Department of Anaesthesiology, S N Medical college, Navanagar, Bagalkot, Karnataka , 587102.
Navanagar,Bagalkot, karnataka,587102
Bagalkot
KARNATAKA
587102
India 
Phone  9901098533  
Fax    
Email  hulkunds@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mallikarjun A 
Designation  Post Graduate Student 
Affiliation  S N Medical college and HSK hospital and research centre 
Address  S N Medical college and HSK hospital and Research centre, Navanagar, Bagalkot
Navanagar, Bagalkot, Karnataka 587102
Bagalkot
KARNATAKA
587102
India 
Phone  7338587089  
Fax    
Email  drmallikarjun.mka@gmail.com  
 
Source of Monetary or Material Support  
S N medical college and HSK hospital, Navanagar, Bagalkot. 587102 
 
Primary Sponsor  
Name  S nijalingappa medical college and HSK hospital and research institute 
Address  1st floor,Major OT complex , S Nijalingappa medical college and HSK hospital , Bagalkot. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivanand Y Hulakund   Major OT complex   1st floor, S N Medical college and HSK hospital Bagalkot KARNATAKA.
Bagalkot
KARNATAKA 
9901098533

hulkunds@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SNMC INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G473||Sleep apnea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients of both gender aged above 18 years belonging to ASA I,II,or III posted for elective surgery under general anaesthesia during the study period. 
 
ExclusionCriteria 
Details  1)patients refusal to give consent.
2)Patients refusal to answer STOP BANG questionnaire.
3)Patients undergoing head and neck surgery ,neurosurgery ,and emergency surgery.
4)Obstetric patiens , patients with neuromuscular disease , facial abnormalities.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
STOP-BANG questionnaire may predicts difficult mask ventillation and difficult intubation among undiagnosed obstructive sleep apnea patients.  60 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the OSA screening parameter in predicting difficult mask ventilation and difficult intubation in OSA patients to that of non-OSA patients  0 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Obstructive sleep apnea is a condition in which upper airway becomes obstructed during sleep causing hypoxia, hypercarbia, fragmented sleep.  Without proper sleep, the patient may experience excessive daytime sleepiness ,headache, change in behavior, reduced intelligence and even personality change . It is associated with complications like increased risk of hypertension , diabetes, myocardial infarction, stroke, diabetic neuropathy, as well as cognitive dysfunction. The perioperative period is a time of particularly high risk for patients with OSA. Inducing general anaesthesia and maintenance of mask ventilation may be difficult due to airway obstruction from reduced pharyngeal muscle tension, and intubation may be difficult due to the abnormalities of the face or upper airway. Such a difficult intubation can be the main factor leading to increased morbidity and increased death rate  Unfortunately >80% of patients with OSA are undiagnosed before surgery, putting them at risk of complications2 . Gold standard for diagnosing OSA is polysomnography. However it is expensive and not widely available. Therefore anaesthesiologist need a practical pre-operative screening tool to identify patients more likely to have true OSA5 . The aim of the study is to estimate the occurrence and compare utility of OSA screening parameters in predicting difficult mask ventilation and difficult intubation in patients with undiagnosed OSA. 
 Ethical clearance will be taken from ethics committee . Written informed consent will be taken from all the study subjects before enrolment in the study. It is a prospective observational study of patients posted for elective surgery under general anaesthesia. Patients will be identified from daily OT list that satisfy the inclusion criteria. Brief medical history related to study will be taken. Airway assessment using modified mallampatti score, anthropometric data like height, weight, BMI, neck circumference, thyromental distance, sternomental distance will be measured2,6. Along with routine preoperative investigations the patient will be screened based on STOP BANG questionnaire to determine the risk of OSA. 
 STOP BANG questionnaire: Snoring? Do you snore loudly(loud enough to be heard through closed doors or your bed partner elbows you for snoring at night)?. Yes/No.  Tired? Do you often feel tired, fatigue, or sleepy, during the daytime( such as falling asleep during driving or talking to someone?. Yes/No.   Observed? Has anyone observed you stop breathing risk of OSA.  or choking/gasping during your sleep?. Yes/No.  Pressure. Do you have or are being treated for high blood pressure?. Yes/No.  Body Mass Index more than 35 kg/m2?. Yes/No.  Age older than 50?. Yes/No.  Neck size large?(measured around adams apple)  For male, is your shirt collar 17 inches/43cm or large?Yes/No  For female, is your shirt collar 16 inches/41cm or large?Yes/No . Gender= male? Yes/No. 
 For each question, the patient receives one point for a YES response. Sum of each score is taken as the total score. Patients scoring >3 in STOP BANG are taken as patients having OSA .
In the operating theatre, standard ASA monitors like pulse oximeter, non-invasive blood pressure device, Etco2 and ECG leads will be connected to all the patients. Preoxygenation for 3min will be done. Premedication given with inj midazolam(0.05mg/kg) and inj glycoprrolate (0.01mg/kg) will be given. Patients are induced with inj propofol(2mg/kg). Adequacy of mask ventilation will be confirmed and any difficulty in mask ventilation will be recorded. Patients relaxed with inj succinyl choline(2mg/kg), laryngoscopy done using macintosh blade of proper size, and Cormack- Lehane grading will be recorded. Use of additional maneuver, bougie, stylet, external pressure, need of additional or change of operator and ease of intubation are also noted.  Occurrence of difficult mask ventilation , difficult laryngoscopy and difficult intubation are noted using DMV score , Cormack-Lehane grading.  
Difficult Mask Ventilation score:  Mask ventilation, did not attempt - 0 , Easy mask ventilation -1 ,Mask ventilation with oral airway device -2 , Difficult mask ventilation ,unstable or requiring -3 , 2 persons , Unable /impossible mask ventilation -4 .
 Cormack-Lehane Difficult intubation score:
 Able to visualize entire larynx, arytenoids, chords, true and false, epiglottis superior to chords 1
 Chords partially obstructed from view with epiglottis, arytenoids visible 2
 Epiglottis visible only 3
 Soft palate visible only 4
 With the above score visualization will be classified as below:
  Difficult visualization is described as grade 3&4
  Easy visualization is described as grade 1&2.
 
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