| CTRI Number |
CTRI/2017/12/010885 [Registered on: 14/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational analytical study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Sonographic assessment of airway and its association with ease of insertion of airway device during anesthesia |
|
Scientific Title of Study
|
Ultrasonographic assessment of airway and its correlation with ease of insertion of laryngeal mask airway - a prospective observational analytical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VijayalakshmiSivapurapu |
| Designation |
Assistant Professor |
| Affiliation |
IndiraGandhiMedical college and Research Institute |
| Address |
Plot no 7 & 8 (Ground Floor), Logu nagar, Gorimedu, Puducherry
Assistant Professor, Department of Anesthesiology, Indira Gandhi Medical College & Research Institute, Kadirkamam, Puducherry-605009
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442176549 |
| Fax |
|
| Email |
prerana10@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VijayalakshmiSivapurapu |
| Designation |
Assistant Professor |
| Affiliation |
IndiraGandhiMedical college and Research Institute |
| Address |
Plot no 7 & 8 (Ground Floor), Logu nagar, Gorimedu
Assistant Professor, Department of Anesthesiology, Indira Gandhi Medical College & Research Institute, Kadirkamam, Puducherry-605009
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442176549 |
| Fax |
|
| Email |
prerana10@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
VijayalakshmiSivapurapu |
| Designation |
Assistant Professor |
| Affiliation |
IndiraGandhiMedical college and Research Institute |
| Address |
Plot no 7 & 8 (Ground Floor), Logu nagar, Gorimedu
Assistant Professor,
Department of Anesthesiology,
Indira Gandhi Medical College & Research Institute,
Kadirkamam,
Puducherry-605009
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442176549 |
| Fax |
|
| Email |
prerana10@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College & Research Institute, Kathirkamam, Puducherry-605009 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College Research Institute |
| Address |
Kathirkamam, Pondicherry 605009 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vijayalakshmi Sivapurapu |
Indira Gandhi Medical College & Research Institute |
Department of Anaesthesiology, Operation Theatre Complex, Indira Gandhi Medical College and Research Institute, Kathirkamam, Pondicherry 605009
Pondicherry
PONDICHERRY |
9442176549
prerana10@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Indira Gandhi Medical College & Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All American Society of Anaesthesiologists ASA I - III patients coming for general anaesthesia with laryngeal mask airway |
|
| ExclusionCriteria |
| Details |
Pregnant patients, patients with cervical spine injuries or maxillo-facial injuries, patients with carcinoma oropharynx or larynx |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between ultrasonographic measurements of airway with ease of insertion of laryngeal mask airway |
Ease of insertion - time point - immediately after insertion of LMA after obtaining EtCO2 tracing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="350" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2015 |
| Date of Study Completion (India) |
31/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Publication not done yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ultrasonographic assessment of airway can help identify easy or difficulty in insertion of laryngeal mask airway in patients undergoing general anesthesia. Various soft tissue thickness measurements can be taken and correlated with intraoperative difficulty, much better than the conventional methods of airway assessment.
The study recruiment is going on, resulta would be calculated once enrollment is over. |