| CTRI Number |
CTRI/2017/11/010359 [Registered on: 03/11/2017] Trial Registered Prospectively |
| Last Modified On: |
15/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a study to compare two methods of confirmation of placement of proseal LMA by Ultrasound and clinical methods. |
|
Scientific Title of Study
|
TO COMPARE CLINICAL VERSUS ULTRASOUND ASSESSMENT OF CORRECT PLACEMENT OF PROSEAL LARYNGEAL MASK AIRWAY: A PROSPECTIVE RANDOMISED STUDY |
| Trial Acronym |
USGPROSEAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KANIKA RUSTAGI |
| Designation |
D.M. student |
| Affiliation |
AIIMS |
| Address |
departement of oncoanaesthesia and palliative medicine, Dr.B.R.A.I.R.C.H. AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9451124755 |
| Fax |
|
| Email |
drkanika1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Rakesh Garg |
| Designation |
associate professor |
| Affiliation |
AIIMS |
| Address |
departement of oncoanaesthesia and palliative medicine, Dr.B.R.A.I.R.C.H. AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9810394950 |
| Fax |
|
| Email |
drrgarg@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KANIKA RUSTAGI |
| Designation |
D.M. student |
| Affiliation |
AIIMS |
| Address |
departement of oncoanaesthesia and palliative medicine, Dr.B.R.A.I.R.C.H. AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9451124755 |
| Fax |
|
| Email |
drkanika1@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPT OF ONCOANAESTHESIA DR.B.R.A.IRCH, AIIMS |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Departement of oncoanaesthesia and palliative medicine, DR.B.R.A.I.R.C.H. AIIMS |
| 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 |
| Dr Kanika Rustagi |
Dr. Kanika Rustagi |
departement of oncoanaesthesia and palliative medicine, Dr.B.R.A.I.R.C.H. AIIMS, New Delhi
South
DELHI |
9451124755
9451124755
drkanika1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUE OF ETHICS COMITTEE FOR POST GRADUATE RESEARCH, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CANCER PATIENTS UNDERGOING SURGERY, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
group A |
in this group we will confirm position of Proseal LMA by clinical methods alone. |
| Intervention |
Group B |
in this group position of Proseal LMA will be confirmed by USG. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age 18- 65 years of age undergoing onco- surgery requiring general anaesthesia and supraglottic airway device (Proseal Laryngeal mask Airway, PLMA) as an airway management device will be recruited under this study |
|
| ExclusionCriteria |
| Details |
1. Unwilling patients.
2. Patients with unfavourable airway anatomy like patient undergoing head and neck surgeries precluding use of supraglottic airway device.
3. Patients at high risk of aspiration like bowel obstruction, gastro-esophageal reflux disease (GERD).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the use of ultrasonography as a suitable alternative to clinical assessment of PLMA for its accurate placement in patients. |
AFTER PLACEMENT OF PROSEAL LMA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time taken for assessment for the correct placement of PLMA by clinical methods and ultrasonography (USG).
|
intaoperatively we will determine the time taken for assessment |
2. Malposition of PLMA at the end of procedure after positive pressure ventilation.
|
AFTER COMPLETION OF PROCEDURE |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
03/11/2017 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
we will conduct this study with an aim to evaluate
clinical usefulness of the ultrasonographic assessment of confirmation of PLMA
placement as compared to the classical clinical tests
after placement. this study will be done on patients undergoing surgery in our hospital where LMA placement is feasible. we have two groups, first group where position of Proseal LMA will be confirmed by clinical methods and second group where position will be confirmed by USG, then they will be assessed by Fibreoptic Bronchoscopy for its optimal placement. Then we will compare the two techniques. |