FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/12/048423 [Registered on: 23/12/2022] Trial Registered Prospectively
Last Modified On: 22/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   ”Comparison of two airway devices placed above the voice box under vision guidance for the purpose of administrating anesthesia 
Scientific Title of Study   To determine the clinical performance of Laryngeal Mask Airway Pro-seal when compared with Laryngeal Mask Airway Protector using video laryngoscope guided insertion technique in patient under General Anesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nazreen Begam S 
Designation  Junior Resident 
Affiliation  Pondicherry Institute of Medical Sciences  
Address  Room no 113 , Post Graduate Hostel , PG Annexe building Pondicherry Institute of Medical Sciences , Pondicherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9585181187  
Fax    
Email  nazreen4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vidya M V 
Designation  Associate Professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anesthesiology Pondicherry Institute of Medical Sciences Pondicherry Pondicherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9585550838  
Fax    
Email  drmvvidya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vidya M V 
Designation  Associate Professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anesthesiology Pondicherry Institute of Medical Sciences Pondicherry Pondicherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9585550838  
Fax    
Email  drmvvidya@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute of Medical Sciences 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Sciences 
Address  Pondicherry Institute of Medical Sciences , Pondicherry 
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 
Nazreen Begam S  Pondicherry Institute of Medical Sciences  Second floor , ETC building, Department of Anesthesiology ,
Pondicherry
PONDICHERRY 		 9585181187

nazreen4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS Institute Ethics Committee(IEC)  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 
Comparator Agent  Laryngeal Mask Airway Pro-seal and Laryngeal Mask Airway Protector  1.OLP measured once after LMA insertion approximately 10minutes after induction 2.Hemodynamic status measured pre induction , post induction , immediate post insertion of LMA, 3min , 5min, 10min. 3.Post operative complications measured half an hour , first hour, third hour 
Intervention  Laryngeal Mask Airway Pro-seal and Laryngeal Mask Airway Protector  Video laryngoscope guided insertion - used once at the time of insertion of LMA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients belonging to American Society of Anesthesiologists grade I or II
2. Age: above 18yrs and below 65yrs
3. Mouth opening > 5cm
4. Patients posted for short surgical procedures < 3hours 
 
ExclusionCriteria 
Details  1.Emergency surgeries
2.Presence of an upper airway anatomic variation or pathology
3. Surgery requiring lateral or prone position
4. Body mass index greater than 30 kg/m2
5. Patients having aspiration tendency(full stomach, history of stomach surgery,
gastroesophageal reflux, hiatal hernia, sore throat, upper respiratory airway infections).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare oropharyngeal leak pressure (OLP) of LMA Pro-seal and LMA
protector when inserted under vision guidance using video laryngoscope. 		 At 10min 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the ease and accuracy of device insertion, ease of gastric tube placement.
2. To detect the hemodynamic responses induced by airway insertion [blood pressure,
heart rate, oxygen saturation and end-tidal carbon dioxide (EtCO2)].
3. To detect the incidence of postoperative complications such as the presence of blood
on the device and severity of sore throat. 		 1.Once LMA is positioned correctly gastric tube is placed.
2.Hemodynamic responses recorded at pre induction , post induction , 3min , 5min , 10min
3.Post operative complications assessed within 3hrs 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   30/12/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
To determine the clinical performance of Laryngeal Mask Airway Pro-seal when compared with Laryngeal Mask Airway Protector using video laryngoscope guided insertion technique in patient under General Anesthesia. The primary outcome is to compare the oropharyngeal leak pressure and secondary outcomes are to compare the hemodynamic responses and complications


 
Close