| CTRI Number |
CTRI/2021/10/037646 [Registered on: 28/10/2021] Trial Registered Prospectively |
| Last Modified On: |
27/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO KNOW WHICH HAS BETTER OUTCOME AMONG POLYVINYL CHLORIDE AND FLEXOMETALLIC ENDOTRACHEAL TUBE INSERTION THROUGH I-GEL |
|
Scientific Title of Study
|
OUTCOME OF POLYVINYL CHLORIDE VERSUS FLEXOMETALLIC ENDOTRACHEAL TUBE INSERTION THROUGH I-GEL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PREETI JENA |
| Designation |
PG RESIDENT |
| Affiliation |
VSS INSTITUTE OF MEDICAL SCIENCE AND RESEARCH |
| Address |
Dept of Anaesthesiology,Vimsar, Burla
Vimsar, Burla
Sambalpur
ORISSA
768017
India |
| Phone |
768017 |
| Fax |
|
| Email |
preetijena906@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PREETI JENA |
| Designation |
PG RESIDENT |
| Affiliation |
VSS INSTITUTE OF MEDICAL SCIENCE AND RESEARCH |
| Address |
Dept of Anaesthesiology,Vimsar, Burla
Vimsar, Burla
Sambalpur
ORISSA
768017
India |
| Phone |
768017 |
| Fax |
|
| Email |
preetijena906@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradipta kumar Patel |
| Designation |
Associate professor,Dept of Anaesthesia |
| Affiliation |
VSS Institute of medical science and research |
| Address |
Dept of Anaesthesiology, Vimsar, Burla
Vimsar, Burla
Sambalpur
ORISSA
768017
India |
| Phone |
943702284 |
| Fax |
|
| Email |
patelpradipta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VSS Institute of Medical science and Research |
| Address |
Vimsar, Burla, Sambalpur, Odisha, 768017 |
| 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 Preeti Jena |
Vss institute of medical science and research |
Operation theatre of dept of surgery and dept of orthopaedics, vssimsar, Burla
Sambalpur
ORISSA |
8895614414
preetijena906@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE, VEER SURENDRA SAI INSTITUTE OF MEDICAL SCIENCE AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M02||Postinfective and reactive arthropathies, (2) ICD-10 Condition: M843||Stress fracture, (3) ICD-10 Condition: N631||Unspecified lump in the right breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group-f will receive flexometallic endotracheal tube insertion with i-gel as conduit. |
Appropriate size flexometallic endotracheal tube will be inserted using i-gel as conduit after induction with inj propofol 1.5-2 mg per kg and inj vecuronium 0.15 mg per kg. |
| Intervention |
Poly vinyl chloride Endotracheal tube insertion using i-gel as conduit. |
Group- p will be inserted with appropriate size polyvinylchloride endotracheal tube using i-gel as conduit after induction with inj propofol 1.5-2 mg per kg and inj vecuronium at 0.15 mg per kg. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE1and2, mallampati class 1and 2, weight-40-70 kgs, pt undergoing elective surgery under GA requiring ENDOTRACHEAL intubation. |
|
| ExclusionCriteria |
| Details |
Patient with anticipated difficult airway, mallampati grade 3and 4, obese patients, mouth opening<3 cm, patient with increased risk of muscle relaxant, contraindicated to use of muscle relaxant. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| For ENDOTRACHEAL intubation using I-gel as conduit, poly vinyl chloride is better than FLEXOMETALLIC in terms of efficacy, first attempt success rate and time taken for insertion. |
2years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of insertion |
2 years |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
28/10/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to compare the outcome of polyvinylchloride endotracheal tube and flexometallic endotracheal tube insertion using i-gel as conduit in terms of efficacy, no of attempts and time taken for insertion. |