| CTRI Number |
CTRI/2024/05/066776 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of lubricants on endotracheal tube removal: Lignocaine gel versus normal saline |
|
Scientific Title of Study
|
Comparison of lignocaine gel and normal saline as lubricants on the ease of removal of a stylet from the endotracheal tube during intubation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparna Pradeep |
| Designation |
Postgraduate Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, VMMC and Safdarjung Hospital, Ansari Nagar (in front of AIIMS)
Delhi
South
DELHI
110029
India |
| Phone |
9400408040 |
| Fax |
|
| Email |
appzaparnapradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Kumar |
| Designation |
Consultant and Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, VMMC and Safdarjung Hospital, Ansari Nagar (in front of AIIMS)
Delhi
South
DELHI
110029
India |
| Phone |
9899689829 |
| Fax |
|
| Email |
drmeenakshi86@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Aparna Pradeep |
| Designation |
Postgraduate Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, VMMC and Safdarjung Hospital, Ansari Nagar (in front of AIIMS)
Delhi
South
DELHI
110029
India |
| Phone |
9400408040 |
| Fax |
|
| Email |
appzaparnapradeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, VMMC and Safdarjung Hospital, Ansari Nagar (in front of AIIMS)
New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, VMMC and Safdarjung Hospital, Ansari Nagar (in front of AIIMS)
Delhi |
| 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 |
| Aparna Pradeep |
Vardhman Mahavir Medical College and Safdarjung Hospital |
OT 1/2/3
Main OT Complex, VMMC and Safdarjung Hospital
New Delhi
South
DELHI |
9400408040
appzaparnapradeep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
Normal saline |
Freshly opened bottle of normal saline will be poured on the stylet with excess saline being shaken off |
| Intervention |
Sterile lignocaine gel |
Sterile lignocaine gel will be applied along the length of the stylet |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery under general anaesthesia requiring endotracheal intubation belonging to American Society of Anaesthesiology classification I or II, Modified Mallampati grade I or II, Body mass index less than 30kg/m2 |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway, Patients with high risk of aspiration. |
|
|
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 |
| Force in Newton (using a spring balance) required to remove stylet from endotracheal tube in patients undergoing intubation for surgery under general anaesthesia |
At the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare- time taken to remove the stylet from endotracheal tube, hemodynamic parameters following intubation, incidence of post operative sore throat using POST scoring system and its association with extraction force applied |
hemodynamic parameters at insertion, after removal of stylet and after 5 mins of removal
Post operative sore throat using POST scoring at 6h,12h and 24 hours post op |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
14/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a Prospective Comparative Study aiming to compare the effect of lignocaine gel and normal saline as lubricants on the ease of removal of stylet from the endotracheal tube during intubation in a total of 80 patients. The primary outcome measured will be the force in Newton (using a digital force gauge) required to remove the stylet from the endotracheal tube during intubation. Secondary outcome measured will be the time taken to remove the stylet from the endotracheal tube, hemodynamic parameters following intubation and incidence of post operative sore throat using POST scoring at 6h, 12h and 24h post op and its association with the extraction force applied. |