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CTRI Number  CTRI/2022/04/042324 [Registered on: 29/04/2022] Trial Registered Prospectively
Last Modified On: 22/06/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Ultrasound neck for predicting difficult mask ventilation and difficult laryngoscopy 
Scientific Title of Study   Prediction of difficult mask ventilation and difficult laryngoscopy by pre-operative ultrasound-based measurement of airway parameters  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishali Waindeskar 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  Professor, Department of Anaesthesiology,AIIMS,Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone  9575604490  
Fax    
Email  vaishali.anesth@aiimsbhopal.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr S R A N Bhushanam Padala 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  Assistant Professor, Department of Anaesthesiology, AIIMS, Bhopal.

Bhopal
MADHYA PRADESH
462020
India 
Phone  7893562302  
Fax    
Email  padala72@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S R A N Bhushanam Padala 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  Assistant Professor, Department of Anaesthesiology, AIIMS, Bhopal.

Sagar
MADHYA PRADESH
462020
India 
Phone  7893562302  
Fax    
Email  padala72@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical sciences,Bhopal 
 
Primary Sponsor  
Name  All India Institute of Medical SciencesBhopal 
Address  Saket Nagar Bhopal 462020 
Type of Sponsor  Other [Self] 
 
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 Vaishali Waindeskar  All India Institute of Medical Sciences, Bhopal  2nd and 3rd floor, Department of anaesthesia,Hospital building,AIIMS,Bhopal
Bhopal
MADHYA PRADESH 
9575604490

vaishali.anesth@aiimsbhopal.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients between 18-65 years undergoing elective surgeries under general anesthesia with muscle relaxation and endotracheal intubation in various surgical specialties 
 
ExclusionCriteria 
Details  1. Respiratory distress in the preoperative period
2. Patients with known facial, cervical, pharyngeal and epiglottic cancer
3. Patients with head and neck trauma
4. Patients who have undergone previous thyroid surgery or tracheostomy
5. Pregnant patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ultrasound based airway parameters-
1. Distance from skin to hyoid bone
2. Distance from skin to thyroid isthmus
3. Thickness of base of the tongue
Conventional clinical assessment-
1. Modified Mallampati grading
2. Upper lip bite test
Body mass index and other demographic variables like age, gender
Cormack-Lehane grading
Han scale grading
 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="114" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   05/06/2022 
Date of Study Completion (India) 09/02/2023 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   may publish prospectively after completion of the trail 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The unanticipated difficult airway is a potentially life-threatening event. Predicting the difficulties with airway management currently remains a challenge and the incidence of death and brain damage related to airway management is about 25% of relevant incidents reported during general anesthesia. Several authors have shown that the described risk factors have low predictability in anticipating difficult airway. Future research is needed to develop tests with high sensitivities and to better screen difficult face mask ventilation and failed intubation.

                                   Pre-operative ultrasound measurement of the anterior neck soft-tissue thickness at different levels, combined with the commonly used screening tests and risk factor assessment for difficult laryngoscopy might improve the ability to predict difficult laryngoscopy. Research regarding difficult mask ventilation combined with difficult laryngoscopy is extremely limited even though these two aspects of airway management are closely related. 

                                   The aim of our study is to evaluate the accuracy of preoperative ultrasound assessment of neck anatomy in predicting difficult mask ventilation and difficult laryngoscopy in patients undergoing elective surgery with general anesthesia

Primary objective:

To correlate preoperative upper airway ultrasound measurements to predict difficult mask ventilation and difficult laryngoscopy

Secondary objectives:

·      To correlate findings of upper airway ultrasound measurements with body mass index (BMI) in predicting difficult mask ventilation and difficult laryngoscopy

·      To compare upper airway ultrasound measurements with conventional clinical assessments in predicting difficult mask ventilation and difficult laryngoscopy

·      To evaluate the demographic variables associated with difficult mask ventilation and difficult laryngoscopy

Methods:

                          This will be a prospective observational study conducted on 114 adult patients of either sex, between 18-65 years undergoing elective surgeries under general anesthesia with muscle relaxation and endotracheal intubation in various surgical specialties at All India Institute of Medical Sciences, Bhopal, India. Institutional human ethics committee approval will be obtained before starting the trial. In the preoperative area, upper airway ultrasound parameters namely, distance from skin to hyoid bone (DSHB), distance from skin to thyroid isthmus (DSTI), thickness of base of the tongue (TBT) will be noted. Then the patient will be shifted inside the operation theatre and given general anesthesia. Han scale grading and Cormack-Lahane grading will be noted during mask ventilation and laryngoscopy respectively. The results will be analyzed to assess upper airway ultrasound measurements to predict difficult mask ventilation and difficult laryngoscopy.

Outcome parameters:

Ultrasound based airway parameters:

1.     Distance from skin to hyoid bone (DSHB)

2.     Distance from skin to thyroid isthmus (DSTI)

3.     Thickness of base of the tongue (TBT)

Conventional clinical assessment:

1.     Modified Mallampati grading (MMP)

2.     Upper lip bite test

Body mass index (BMI) and other demographic variables like age, gender

Han scale grading

Cormack-Lahane grading

 
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