| CTRI Number |
CTRI/2024/05/067676 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
19/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE EVALUATION OF PHARYNGOLARYNGEAL MORBIDITY FOLLOWING PROSEAL LARYNGEAL MASK AIRWAY INSERTION USING SUCTION CATHETER GUIDED VERSUS INTRODUCER TOOL GUIDED TECHNIQUE |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF PHARYNGOLARYNGEAL MORBIDITY FOLLOWING PROSEAL LARYNGEAL MASK AIRWAY INSERTION USING SUCTION CATHETER GUIDED VERSUS INTRODUCER TOOL GUIDED TECHNIQUE |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kush RC |
| Designation |
Post Graduate Resident |
| Affiliation |
VMMC and SAFDARJUNG HOSPITAL |
| Address |
Department of Anaesthesia, VMMC and Safdarjung Hospital,Ansari Nagar West
South
DELHI
110029
India |
| Phone |
9540601993 |
| Fax |
|
| Email |
IMKUSH0702@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Rani Sharma |
| Designation |
Director Professor |
| Affiliation |
VMMC and SAFDARJUNG HOSPITAL |
| Address |
Department of Anaesthesia, VMMC and Safdarjung Hospital,Ansari Nagar West
South
DELHI
110029
India |
| Phone |
9968604376 |
| Fax |
|
| Email |
drkavitadn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Rani Sharma |
| Designation |
Director Professor |
| Affiliation |
VMMC and SAFDARJUNG HOSPITAL |
| Address |
Department of Anaesthesia, VMMC and Safdarjung Hospital,Ansari Nagar West
South
DELHI
110029
India |
| Phone |
9968604376 |
| Fax |
|
| Email |
drkavitadn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, VMMC and Safdarjung Hospital,Ansari Nagar West, Delhi |
|
|
Primary Sponsor
|
| Name |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
VMMC & SAFDARJUNG HOSPITAL,ANSARI NAGAR WEST, SOUTH DELHI,DELHI,PIN- 110029 |
| 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 |
| Dr Kush RC |
VMMC and Safdarjung Hospital |
Department of Anaesthesia, Ground Floor, OT Building, Safdarjung Hospital, Ansari nagar West
South
DELHI |
9540601993
IMKUSH0702@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
pLMA insertion with introducer tool guided technique |
Evaluation of post operative comorbidity following pLMA insertion with introducer tool guided technique |
| Intervention |
pLMA insertion with suction catheter guided technique |
Evaluation of post operative comorbidity following pLMA insertion with suction catheter guided technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade 1 and 2
2. Patient undergoing elective surgery requiring General Anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Pregnant Women
2.Patients requiring Endotracheal Intubation
3.Limited mouth opening
4.Known bleeding or coagulation disorder
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the incidence of pharyngolaryngeal morbidity with the use of suction catheter guided technique versus standard introducer tool guided technique during proseal laryngeal mask airway insertion with regard to incidence of sore throat |
1. Baseline
2. 30 minutes post pLMA Removal
3. 2 hour post pLMA Removal
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of
a. Hoarseness of voice
b. Dysphagia
c. Cough
d. Oral/ pharyngeal trauma/ presence of blood on device
Post operative sore throat score
Time required for Proseal Laryngeal Mask Airway insertion |
O min.
5 min.
15 min
30 min
2 hrs
1 day post completion of surgery
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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="0"
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
|
We propose to Compare the incidence of pharyngolaryngeal morbidity with the use of suction catheter guided technique versus standard introducer toll guided technique during Proseal Laryngeal Mask Airway insertion with regard to incidence of sore throat, Hoarseness of voice ,Dysphagia, Cough, Oral/ pharyngeal trauma / presence of blood on device , Post operative sore throat score and time required for Proseal Laryngeal Mask Airway insertion. |