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CTRI Number  CTRI/2023/12/060477 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 23/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To study the effect of surgery done in lying on stomach position on the oral structures in adult patients undergoing backbone surgery  
Scientific Title of Study   Evaluation of the effect of prone position on the modified Mallampati class in adult patients undergoing thoracolumbar spine surgery 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anil Kumar 
Designation  Postgraduate student 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi

South
DELHI
110029
India 
Phone  8368624124  
Fax    
Email  anilkumar.1234269@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Smita Prakash 
Designation  Professor  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi

South
DELHI
110029
India 
Phone  9810347125  
Fax    
Email  drsunilprakash@gmail.com  
 
Details of Contact Person
Public Query  
Name  Smita Prakash 
Designation  Professor  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi

South
DELHI
110029
India 
Phone  9810347125  
Fax    
Email  drsunilprakash@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi  
 
Primary Sponsor  
Name  Safdarjung Hospital 
Address  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 
Type of Sponsor  Government 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 Smita Prakash  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi  Main Operation Theatre, 3rd Floor, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 New Delhi 110029
South
DELHI 		 26198462

drsunilprakash@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists physical status I and II, scheduled for thoracolumbar spine surgery in prone position 
 
ExclusionCriteria 
Details  Inability to fully open mouth for assessment, pre-existing oropharyngeal pathology, severely limited neck mobility, unstable cervical spine, pregnant patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate changes in modified Mallampati class at various timepoints in the first 48-hour postoperative period in patients undergoing thoracolumbar spine surgery in prone position  Preoperative and postoperative at 1h, 2h, 4h, 8h, 12h, 24h, 48h  
 
Secondary Outcome  
Outcome  TimePoints 
1.Time taken for regression in modified Mallampati class to baseline values in patients undergoing thoracolumbar spine surgery in prone position.
2.To study association of change in modified Mallampati class with age, body weight.
duration of laryngoscopy, intubation attempts, duration of surgery, intraoperative fluid administered and estimated blood loss.
 		 Postoperative at 1h, 2h, 4h, 8h, 12h, 24h, 48h  
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/12/2023 
Date of Study Completion (India) Date Missing 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Perioperative airway changes due to anaesthesia and surgery could change a normal airway at induction to a risky airway at extubation. Complications such as oropharyngeal swelling, due to macroglossia, sublingual haematoma and salivary gland inflammation, may occur during prolonged surgery in the prone position, more so if the head and neck position is non-neutral.   Airway changes may occur due to prone surgical positioning. there is paucity of literature on the changes in modified Mallampati class in adult patients undergoing thoracolumbar spine surgery in prone position. We hypothesise that modified Mallampati class changes in adult patients undergoing thoracolumbar spine surgery in prone position. The purpose of our study is to evaluate changes in modified Mallampati class in 35 adult patients undergoing thoracolumbar spine surgery in prone position.

 
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