| CTRI Number |
CTRI/2024/03/063864 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Comparison of Tracheostomy techniques ] |
| Study Design |
Other |
|
Public Title of Study
|
Two techniques to make hole in upper airway to give breaths in patients on ventilator. |
|
Scientific Title of Study
|
Comparison of single dilator vs dilator forceps technique for USG guided percutaneous dilational tracheostomy in trauma intensive care unit. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seema Rani |
| Designation |
PG Resident |
| Affiliation |
Dr SNMC,Jodhpur,Rajasthan |
| Address |
Department of anaesthesia and critical care,Dr SNMC,JODHPUR,RAJASTHAN ,342003
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9817442904 |
| Fax |
|
| Email |
seemgill2864@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Rajpurohit |
| Designation |
Professor |
| Affiliation |
Dr SNMC,Jodhpur, Rajasthan |
| Address |
Department of anaesthesia and critical care,Dr SNMC, JODHPUR, RAJASTHAN
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9928060011 |
| Fax |
|
| Email |
drvikasrajpurohit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Rajpurohit |
| Designation |
Professor |
| Affiliation |
Dr SNMC,Jodhpur, Rajasthan |
| Address |
Department of anaesthesia and critical care,Dr SNMC, JODHPUR, RAJASTHAN
RAJASTHAN
342003
India |
| Phone |
9928060011 |
| Fax |
|
| Email |
drvikasrajpurohit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr SNMC,Jodhpur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Dr SNMC, Jodhpur, Rajasthan |
| Address |
Dr SNMC,Shastri Nagar,Residency Road,Jodhpur, Rajasthan ,342003 |
| 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 Seema Rani |
MDM Hospital |
Trauma ICU,First floor over New OPD,department of anaesthesia and critical care,MDM hospital,Dr SNMC, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN |
9817442904
seemagill2864@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Dr SNMC,Jodhpur , Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S066||Traumatic subarachnoid hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing single dilator vs dilator forceps technique for USG guided percutaneous tracheostomy. |
In this 6months duration study,i will compare outcomes of using single dilator vs dilator forceps for USG guided percutaneous tracheostomy in term of mean time taken to secure airway,ease of performing procedure and complications. |
| Intervention |
USG guided Percutaneous tracheostomy |
There are 2 groups.One group is assigned for using single dilator and other group is assigned for using dilator forceps technique while performing USG guided percutaneous tracheostomy in trauma intensive care unit,comparing mean time taken to secure airway,ease of performing procedure and complications for study duration of 6months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted in icu requiring tracheostomy for elective prolonged mechanical ventilation |
|
| ExclusionCriteria |
| Details |
Patients with
Cervical spine injury
Oxygen requirement greater than 80%Fio2 or PEEP greater than 10 cm of water
Who had undergone previous neck surgeries
Thyroid swelling and undergoing/undergone radiotherapy on neck region
With tracheo-esophageal fistula
Coagulopathy
Infection involving the operative site
Non intubated patients
BMI greater than or equal to 35kg /m2
Anatomical distortion of trachea or pre-existing tracheomalacia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare mean time taken to secure airway with single dilator vs dilator forceps technique in patients requiring mechanical ventilation in trauma ICU. |
5minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A) Ease of performing percutaneous tracheostomy using single dilator vs dilator forceps technique
B) Complications |
72 hrs |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/03/2024 |
| 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="0"
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
|
The aim of this study is to compare two techniques of percutaneous dilational tracheostomy-single dilator vs dilator forceps techniques in patients requiring mechanical ventilation in trauma ICU in terms of time duration and ease of performing two techniques Primary objective- to compare mean time taken to secure airway with single dilator vs dilator forceps technique in patients requiring mechanical ventilation in trauma icu Secondary objective- to compare ease of performing percutaneous tracheostomy using single dilator vs dilator forceps technique and Complications |