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CTRI Number  CTRI/2021/04/033223 [Registered on: 28/04/2021] Trial Registered Prospectively
Last Modified On: 09/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study
Modification(s)  
PROSPECTIVE 
Study Design  Other 
Public Title of Study   An observational study to understand the efficacy of Ultrasound in confirming the correct placement of I-gel(an airway device)compared to Video-bronchoscopy. 
Scientific Title of Study   Efficacy of Ultrasound in confirming correct placement of I-gel compared to Video-bronchoscopy:A prospective observational 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 Rajasree O 
Designation  Associate Professor 
Affiliation  Associate Proffesor in Anaesthesiology affliated to Regional Cancer Centre Thiruvanathapuram  
Address  Department of Anaesthesiology Regional Cancer Centre Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  8281227024  
Fax    
Email  milisajan@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amina S 
Designation  Junior Resident  
Affiliation  1st year PG Resident in Anaesthesiology affliated to Regional Cancer Centre Thiruvanathapuram  
Address  Department of Anaesthesiology Regional Cancer Centre Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9847927775  
Fax    
Email  aminas93@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajasree O 
Designation  Associate Professor 
Affiliation  Associate Proffesor in Anaesthesiology affliated to Regional Cancer Centre Thiruvanathapuram  
Address  Department of Anaesthesiology Regional Cancer Centre Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  8281227024  
Fax    
Email  milisajan@hotmail.com  
 
Source of Monetary or Material Support  
Regional Cancer Centre Trivandrum Kerala  
 
Primary Sponsor  
Name  Dr Rajasree O 
Address  Associate Professor Department Of Anaesthesiology Regional Cancer Centre TRIVANDRUM 
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 Rajasree O  Regional Cancer Centre Trivandrum  Department of Anaesthesiology Operation theatre complex
Thiruvananthapuram
KERALA 
8281227024

milisajan@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HUMAN ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ULTRASOUND , VIDEO-BRONCHOSCOPY  After the patient being received to OT,B mode ultrasound will be performed on the anterior neck using a 8 to 13-Mhz linear probe of the Esaote ultrasound machine (Model No.3PCON), to assess the airway and findings will be recorded. The glottic image will be saved for later analysis. After USG,I-gel will be inserted using standard method. After five minutes USG will be repeated on the anterior neck.To assess the position, video bronchoscopy will be performed via the I-gel that has been placed.After video bronchoscopy; ultrasound is again performed and positional displacement of arytenoids is evaluated after which comparison of pre I-gel and post l-gel UST images will be done. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Patients scheduled for breast sugeries under general anaesthesia,belonging to ASA physical status I and II,and those giving consent will be taken up for the study. 
 
ExclusionCriteria 
Details  The following patients will be excluded;
Patients with anticipated difficult airway,restrictive or obstructive pulmonary disease,previous thoracic surgeries,pregnancy,BMI >30,those at risk of gastric aspiration,and those who did not give consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare USG images and video-bronchoscopy images in detecting the correct placement of I-gel.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To find the interrelationship between USG detected and video-bronchoscopy detected malposition of the I-gel and to determine the diagnostic capability of USG in detecting I-gel malposition.  1year 
 
Target Sample Size   Total Sample Size="153"
Sample Size from India="153" 
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   Phase 2 
Date of First Enrollment (India)   01/06/2021 
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="0"
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  
The devolopment of supraglottic airway devices[SAD] has revolutionised the airway management in anaesthesia practice.I-gel bieng a second generation SAD, bridges the niche between facemask and tracheal tube. The position of I-gel can be confirmed by various clinical methods inorder to avoid any airleaks and to ensure adequate ventilation.But one cannnot completely rely on clinical methods for confirming correct positioning of I-gel.Sub-optimal anatomical  positioning with complete or partial obstruction of glottic aperture cannot ruled out by clinical methods alone.Clinical studies have shown that direct visualisation with Video-bronchoscopy can ensure correct placement of SAD, but its use is restricted due to its invasive nature and the need for thorough sterilisation and related expenses.
In these circumstances, the use of Ultrasound[US] have made correct positiong of I-gel, more reassuring.Hence we planned to compare the efficacy of Ultrasound[US] in confirming correct placement of I-gel with Video-bronchoscopy.
The primary objective of the study is to compare the USG images and Video-bronchoscopy images in detecting correct placement of I-gel. The secondary objective is to find the interrelationship between US detected and Video-bronchoscopy detected malposition of the I-gel and to determine the diagnostic capability of USG in detecting the I-gel malposition.
The expected outcome of the study is to detect the extend of malposition with USG aretynoid grade and Video-bronchoscopy I-gel rotation grade. Early detection of malposition can help in preventing intraoperative and postoperative complications by adjusting the position or replacing with I-gel of another size.
 
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