| CTRI Number |
CTRI/2024/03/064941 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing position of an airway device known as ProSeal LMA using ultrasound and flexible bronchoscopy in children scheduled for surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparison of ultrasonography and flexible bronchoscopy for evaluation of placement of ProSeal Laryngeal Mask Airway in paediatric patients undergoing elective surgery under general anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KIRANJOT KAUR |
| Designation |
First year Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South West
DELHI
110029
India |
| Phone |
9205864409 |
| Fax |
|
| Email |
doctor7k.official@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suniti Kale |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesia Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South West
DELHI
110029
India |
| Phone |
9810287852 |
| Fax |
|
| Email |
findsuniti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KIRANJOT KAUR |
| Designation |
Post graduate resident |
| Affiliation |
Department of Anaesthesia Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South West
DELHI
110029
India |
| Phone |
9205864409 |
| Fax |
|
| Email |
doctor7k.official@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Vardhman Mahavir medical college and Safdarjung hospital |
| Type of Sponsor |
Government medical college |
|
|
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 |
| KIRANJOT KAUR |
Vardhman Mahavir medical college and Safdarjung hospital |
Department of Anaesthesia
Vardhman Mahavir medical college
South West
DELHI |
9205864409
doctor7k.official@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients aged 3 to 12 years belonging to American Society of Anesthesiologists ASA grade I and II scheduled for elective surgery in supine position under general anaesthesia requiring ProSeal LMA placement as an airway device |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway
Children at increased risk of aspiration
Obese children with BMI more than 30 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the agreement between Ultrasonographic and Flexible bronchoscopic evaluation of placement of ProSeal Laryngeal Mask Airway in paediatric patients undergoing elective surgery under general anaesthesia. |
Baseline, after induction, immediately after LMA insertion, 5 minutes after LMA insertion, 10 minutes after LMA insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time taken to evaluate the placement of ProSeal Laryngeal Mask Airway in paediatric patients by Ultrasonography & Flexible bronchoscopy |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/06/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is intended to evaluate the feasibility of using ultrasound to evaluate the placement of a ProSeal LMA (PLMA) compared to the gold standard bronchoscopy. Children aged 3 to 12 years planned for elective surgery in supine position under general anaesthesia with ProSeal LMA placement will be selected for this study. Inj Fentanyl (2 mcg/kg) + Inj Propofol (2 mg/kg) will be given for induction. Inj Vecuronium (0.1 mcg/kg) will be given for facilitating PLMA placement. PLMA of appropriate size (according to weight based criteria) will be inserted. Placement of PLMA will be confirmed using clinical parameters (Visible bilateral chest rise , bilateral equal air entry on auscultation, SPO2 > 95%, successful insertion of gastric tube, capnogram). Patients with ‘Clinically acceptable’ placed PLMA will be selected for this study. In these patients USG will be done followed by flexible bronchoscopy. Ultrasonographic evaluation of placement of PLMA will be done in 3 planes and scoring will be done. Flexible bronchoscopic evaluation of placement of PLMA and Brimacombe grading will be done. After completion of surgery, neuromuscular blockade reversal will be given and trachea will be extubated. Patient will be observed in PACU for 2 hours. This study aims to correlate the number of USG-acceptable PLMA placements with number of flexible bronchoscope confirmed correct PLMA placements.
|