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CTRI Number  CTRI/2021/05/033484 [Registered on: 07/05/2021] Trial Registered Prospectively
Last Modified On: 25/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The efficiency of cricoid pressure will be measured using a novel pressure sensor device. 
Scientific Title of Study   EFFICACY OF CRICOID PRESSURE MEASURED BY A NOVEL CRICOID PRESSURE SENSOR DEVICE- A RANDOMISED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhilasha Mishra 
Designation  Junior Resident  
Affiliation  Department of Anaesthesia and Intensive Care PGIMER Chandigarh 
Address  Department of Anaesthesia and Intensive Care PGIMER Chandigarh sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  9967929504  
Fax  00911722744401  
Email  mishra.abhi294@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preethy J Mathew  
Designation  Professor  
Affiliation  Department of Anaesthesia and Intensive Care PGIMER Chandigarh 
Address  Department of Anaesthesia and Intensive Care PGIMER Chandigarh Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009530  
Fax  00911722744401  
Email  tjpreethy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Preethy J Mathew  
Designation  Professor  
Affiliation  Department of Anaesthesia and Intensive Care PGIMER Chandigarh 
Address  Department of Anaesthesia and Intensive Care PGIMER Chandigarh Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009530  
Fax  00911722744401  
Email  tjpreethy@gmail.com  
 
Source of Monetary or Material Support  
"Department of Anaesthesia and Intensive Care, PGIMER Chandigarh" 
 
Primary Sponsor  
Name  Department of Anaesthesia and Intensive Care PGIMER Chandigarh 
Address  PGIMER Chandigarh Sector 12 160012 
Type of Sponsor  Research institution and hospital 
 
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 
Abhilasha Mishra  PGIMER Chandigarh  Elective Operation Theatres of PGIMER Chandigarh, Sector 12 160012
Chandigarh
CHANDIGARH 		 9967929504
00911722744401
mishra.abhi294@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1 Advanced trained operator with feedback group  Cricoid pressure will be applied by one of the trained operation theatre technician who will be able to see the cricoid force measured on the device during application. 
Comparator Agent  Group 2 Conventionally trained operator with no feedback group  Cricoid pressure will be applied by one of conventionally trained operator who will not be able to see the cricoid force measured on the device during application 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1-ASA physical status 1 or 2
2-Scheduled to undergo elective surgery
3-Anaesthetic plan should include general anaesthesia requiring tracheal intubation
 
 
ExclusionCriteria 
Details  Denial to be a part of study.
Diseases with abnormalities of neck, larynx, pharynx, oesophagus or thyroid.
Risk of aspiration of gastric contents requiring Rapid Sequence Induction and Intubation.
Anticipated or predicted difficult airway.
BMI >35 kg/m2
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Rate of occlusion of oesophageal entrance on application of cricoid force.  Immediate 
 
Secondary Outcome  
Outcome  TimePoints 
Cricoid force applied at various time intervals  0s, 5s, 10s, 15s, 20s, 25s, 30s, 35s, 40s, 45s, 50s, 55s, 60s 
Position of occluded oesophagus in relation to glottis during application of cricoid pressure on ultrasound neck.  Immediate 
3-Position of occluded oesophagus in relation to glottis during application of cricoid pressure on videolaryngoscopy.  Immediate  
Intubation time in seconds  Immediate  
Number of attempts for tracheal tube insertion  Immediate 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="65" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2021 
Date of Study Completion (India) 16/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The primary purpose is to evaluate the effectiveness of cricoid pressure when applied with and without the aid of cricoid pressure sensor device. Two groups will be randomly allocated and cricoid pressure will be applied by operation theatre technician and the reading on cricoid pressure monitoring will be shown or not according to the group. The efficacy will be measured in terms of oesophagus occlusion on ultrasound and videolaryngoscopy.  
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