| CTRI Number |
CTRI/2024/02/062912 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
18/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out the injuries in the voice box (vocal cords) after using double lumen tube (type of a tube inserted through the vocal cord for administering general anaesthesia) |
|
Scientific Title of Study
|
A prospective observational study on assessment of vocal cord injuries after placement of double lumen tube. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4206_Version 2.0,Dated 20/10/23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijaya Patil |
| Designation |
Professor and head,Divison of Clinical Anaesthesia |
| Affiliation |
Tata Memorial Hospital |
| Address |
Second floor, Main Building,
Department of Anaethesia,Critical care and Pain ,
Tata Memorial Hospital,
Dr.E. Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9819883535 |
| Fax |
|
| Email |
vijayappatil@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijaya Patil |
| Designation |
Professor and head,Divison of Clinical Anaesthesia |
| Affiliation |
Tata Memorial Hospital |
| Address |
Second floor, Main Building,
Department of Anaethesia,Critical care and Pain ,
Tata Memorial Hospital,
Dr.E. Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9819883535 |
| Fax |
|
| Email |
vijayappatil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Eesha Patwardhan |
| Designation |
Junior resident, Department of Anaesthesia Critical care and Pain |
| Affiliation |
Tata Memorial Hospital |
| Address |
Second floor, Main Building
Department of Anaesthesia Crtical Care and Pain,
Tata Memorial Hospital
Dr E. Borges Road,
Parel, Mumbai
Thane
MAHARASHTRA
400094
India |
| Phone |
8879108028 |
| Fax |
|
| Email |
eeshapatwardhan97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital,
Dr. E. Borges Road,
Parel,Mumbai
400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital
Dr E Borges road
Parel
Mumbai |
| 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 Vijaya Patil |
Tata Memorial Hospital,Mumbai |
Second floor, Main Building,
Department of Anaethesia,Critical care and Pain ,
Tata Memorial Hospital,
Dr.E. Borges Road
Parel
Mumbai
Mumbai
MAHARASHTRA |
9819883535
vijayappatil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NA |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
(1)Adult (≥18 years old) patients
(2)Scheduled for surgical procedures requiring placement of double lumen tubes
|
|
| ExclusionCriteria |
| Details |
(1) Preexisting laryngeal injury/disease
(2) Patients with preexisting recurrent laryngeal nerve injuries.
(3) Patients intubated for more than or equal to 24 hours in last 6 months.
(4) Non cooperative and not willing to participate in the study to undergo stroboscopy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of vocal cord injuries after DLT placement |
Stroboscopy would be performed before surgery which will be considered as baseline and at 48 hours after surgery to assess injuries and compare two results |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Types of injuries can be studies
2.Factors affecting the injuries of vocal cords such as the type of DLT used, the designation of person intubating, number of attempts required for repositioning the DLT. |
Stroboscopy would be performed before surgery which will be considered as baseline & at 48 hours after surgery to assess injuries & compare two results. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
04/03/2024 |
| 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) |
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
|
Endotracheal tube is required for patients undergoing general anesthesia .Though it is a safe procedure it is not without its risks .It can cause injuries to oral cavity and vocal cords. For procedures requiring lung isolation ,placement of double lumen tube is essential . Double lumen tube has larger diameter and requires more intraoperative manipulations. Thus chances of vocal cord injuries caused by double lumen tubes is also more .Hence plan of this study is to assess vocal cord injuries using stroboscopy. Stroboscopy is based on Talbot law, which states that images persist on the human retina for very short time after exposure. Interpreting sequential images that correspond to an object in motion is a fundamental principle. Consequently stroboscopy leverages these principles by generating intermittent light flashes in close synchronization with the frequency of vocal cord vibration. Thus study of stroboscopy helps to study in depth intricate patterns of vocol cord vibration and mucosal waves. Thus we can identify the injuries at the earliest. Patients would be recruited from thoracic out patient department and stroboscopy would be performed by Head and neck team. Stroboscopy would be performed twice pre operatively and within 48 hours after placement of double lumen tube. |