| CTRI Number |
CTRI/2020/01/023026 [Registered on: 28/01/2020] Trial Registered Prospectively |
| Last Modified On: |
14/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON AND EVALUATION OF POLYVINYL CHLORIDE TUBE AND FLEXOMETALLIC TUBE ENDOTRACHEAL FOR EASE OF OROTRACHEAL INTUBATION USING FLEXIBLE BRONCHOSCOPE IN ADULTS |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF TWO DIFFERENT ENDOTRACHEAL TUBES FOR EASE OF OROTRACHEAL INTUBATION IN ADULTS USING FLEXIBLE BRONCHOSCOPE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hage Kanya |
| Designation |
Post Graduate MD Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8794383491 |
| Fax |
|
| Email |
Kanyahage06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ameeta Sahni |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9811201585 |
| Fax |
|
| Email |
Ameetaas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Hage Kanya |
| Designation |
Post Graduate MD Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8794383491 |
| Fax |
|
| Email |
Kanyahage06@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,Ansari Nagar, New 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 |
| Hage Kanya |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesiology
South
DELHI |
8794383491
Kanyahage06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Orotracheal intubation using flexible bronchoscope and flexometallic tube |
Patient undergoing elective surgery under general anaesthesia will be intubated orally with a flexometallic tube using flexible bronchoscope, while observing the passage of the tube through the glottis using a pediatric endoscope inserted nasally. |
| Comparator Agent |
Orotracheal intubation using flexible bronchoscope and polyvinyl chloride tube |
Patient undergoing elective surgery under general anaesthesia will be intubated with a polyvinyl chloride tube using a flexible bronchoscope while observing the passage of the tube through the glottis using a pediatric endoscope inserted nasally. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1&2, Modified Mallampati Grade 1&2, undergoing elective general surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients having a difficult airway or is undergoing oral, head or neck surgery or is pregnant |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess ease of passage by observing and comparing the incidence of impingement of the polyvinyl chloride tube and the flexometallic tube at the glottis using flexible bronchoscope |
At the end of complete sample collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Site of impingement of tube, if any. 2. The number of manoeuvres required to advance the endotracheal tube through the glottis. 3. The time taken to railroad the endotracheal tube over the flexible bronchoscope into the trachea |
At the time of intubation |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/02/2020 |
| Date of Study Completion (India) |
31/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an interventional randomised comparative study to find out which endotracheal tube between the polyvinyl chloride tube and the flexometallic tube has easier passage at the glottis for orotracheal intubation ,using a flexible bronchoscope, with the hypothesis that the flexometallic tube has easier passage at the glottis than the polyvinyl chloride tube. The two tubes will be compared based on following parameters: primarily,1) rate of impingement of tube, secondarily, 2) site of impingement of tube, if any, 3) number of manoeuvres required to advance the tube, 4) the time taken to railroad the tube over the flexible bronchoscope. |