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
|
|
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
|
|
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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