| CTRI Number |
CTRI/2025/07/090796 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Retrospective Analysis of percutaneous dilatational tracheostomy in a multidisciplinary intensive care unit. |
|
Scientific Title of Study
|
Safety and efficacy of percutaneos dilatational tracheostomy in ICU patients
A Retrospective review |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaidyanathan R |
| Designation |
Head, Dept of Anaesthesia & Intensive Care |
| Affiliation |
Cauvery Heart and Multispeciality Hospital |
| Address |
Second Floor,Cauvery Heart and Multispeciality Hospital.Near Teresian Circle,Bannur Road.Mysore.Karnataka.
Second Floor,Cauvery Heart and Multispeciality Hospital.Near Teresian Circle,Bannur Road.Mysore.Karnataka.
Mysore
KARNATAKA
570029
India |
| Phone |
9886031067 |
| Fax |
|
| Email |
vaidyanathandr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaidyanathan R |
| Designation |
Head, Dept of Anaesthesia & Intensive care.HOD |
| Affiliation |
Cauvery Heart and Multispeciality Hospital |
| Address |
Second Floor,Cauvery Heart and Multispeciality Hospital.Near Teresian Circle,Bannur Road.Mysore.
Second Floor,Cauvery Heart and Multispeciality Hospital.Near Teresian Circle,Bannur Road.Mysore.
Mysore
KARNATAKA
570029
India |
| Phone |
9886031067 |
| Fax |
|
| Email |
vaidyanathandr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaidyanathan R |
| Designation |
Head, Dept of Anaesthesia & Intensive Care |
| Affiliation |
Cauvery Heart and Multispeciality Hospital |
| Address |
Second Floor,Cauvery Heart and Multispeciality Hospital,Near Teresian Circle, Bannur Road, Mysore
Second Floor,Cauvery Heart and Multispeciality Hospital,Near Teresian Circle, Bannur Road, Mysore
Mysore
KARNATAKA
570029
India |
| Phone |
9886031067 |
| Fax |
|
| Email |
vaidyanathandr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cauvery Heart and Multispeciality Hospital has provided infrastructural support, no monetary support sought.
full address is
Cauvery Heart and Multispeciality Hospital, Near Teresian Circle, Bannur Road, Mysore 570029. Karnataka. India |
|
|
Primary Sponsor
|
| Name |
Cauvery Heart and Multispeciality Hospital |
| Address |
Cauvery Heart and Multispeciality Hospital, Near Teresian circle , Bannur Road, Mysore 570029 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| VAIDYANATHAN R |
Cauvery Heart and Multispeciality Hospital |
Dept of Anaesthesia and Intensive care,Cauvery Heart and Multispeciality Hospital, Near Teresian Circle, Bannur Road, Mysore 570029, Karnataka, India.
Mysore
KARNATAKA |
09886031067
vaidyanathandr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE CAUVERY HEART AND MULTISPECIALITY HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, (2) ICD-10 Condition: G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere, (3) ICD-10 Condition: V899||Person injured in unspecified vehicle accident, (4) ICD-10 Condition: X838||Intentional self-harm by other specified means, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Retrospective analysis of all PCDT(Percutaneous dilatational tracheostomy) procedures done in a multidisciplinary intensive care unit (ICU) during the study period. |
|
| ExclusionCriteria |
| Details |
All patients with coagulopathy or known coagulation disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Procedure related immediate complications and delayed or long term complications. RELATED ACUTE AND LONG TERM COMPLICATIONS |
Immediate complications were assesed immediately during procedure and upto 6 hours primarily bleeding,false passage or pneumothorax and delayed complications primarily tracheal stenosis or granuloma formation upto 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
25/07/2025 |
| 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)
|
Completed |
| 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
|
A retrospective analysis of all the percutaneous dilatational trcheostomy procedures done over a period of 15 years from 2011 - 2015 will be done. The primary objective is to establish it as a safe and efficient procedure in comparison to the standard existing surgical tracheostomy in terms of acute complications like bleeding, any faalse passage or long term complications like scarring or tracheal stenosis. |