| CTRI Number |
CTRI/2019/11/021969 [Registered on: 11/11/2019] Trial Registered Prospectively |
| Last Modified On: |
04/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF DIFFERENT PERCUTANEOUS TRACHEOSTOMY TECHNIQUE |
|
Scientific Title of Study
|
COMPARISON BETWEEN BRONCHOSCOPY GUIDED AND REAL TIME ULTRASOUND GUIDED PERCUTANEOUS TRACHEOSTOMY USING GRIGGS TECHNIQUE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avishek Chakma |
| Designation |
Junior Resident |
| Affiliation |
JNMCH, AMU |
| Address |
Department of Anaesthesiology and critical care
JNMCH,AMU
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8383022438 |
| Fax |
|
| Email |
chakmaavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abu Nadeem |
| Designation |
Assistant Professor |
| Affiliation |
JNMCH,AMU |
| Address |
Departmen t of Anaesthesiology and critical care
JNMCH,AMU
Aligarth
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837757772 |
| Fax |
|
| Email |
drabunadeem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abu Nadeem |
| Designation |
Assistant Professor |
| Affiliation |
JNMCH,AMU |
| Address |
Departmen t of Anaesthesiology and critical care
JNMCH,AMU
Aligarth
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837757772 |
| Fax |
|
| Email |
drabunadeem@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and critical care, JNMCH, AMU |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and critical care |
| Address |
Department of Anaesthesiology and critical care,JNMCH,AMU,ALIGARH |
| 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 |
| AVISHEK CHAKMA |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
Dpartment of Anaesthesiology and critical care, JNMCH,AMU
Aligarh
UTTAR PRADESH |
8383022438
chakmaavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: O151||Eclampsia complicating labor, (3) ICD-10 Condition: T440||Poisoning by, adverse effect of and underdosing of anticholinesterase agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FIBER OPTIC BRONCHOSCOPE GUIDED PERCUTANEOUS TRACHEOSTOMY |
FIBER OPTIC BROCHOSCOPE GUIDED TRACHEOSTOMY USING GRIGGS TECHNIQUE |
| Comparator Agent |
ULTRASOUND GUIDED PERCUTANEOUS TRACHEOSTOMY |
REAL TIME ULTRASOUND GUIDED PERCUTANEOUS TRACHEOSTOMY USING GRIGGS TECHNIQUE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients expected to be on prolong mechanical ventilation(>7 days)
INR MAXIMUM 1.4 |
|
| ExclusionCriteria |
| Details |
Laryngeal/oesophageal/tracheal carcinoma
Soft tissue infection of neck
Anatomical deformity of neck including enlarged thyroid gland
Haematological and terminal malignancies
Coagulation disorder
Previous tracheostomy
Platelet count less than or equal to 80,000 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see total time duration taken for fiber optic bronchoscopy guided and real time ultrasound guided percutaneous tracheostomy using griggs technique. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare number of needle puncture attempts
incidence of complications of these proceduresand to see accuracy which is defines as wheter puncture is at the centre , site of puncture space and visualization of griggs forcep time in the space. |
one and half years |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
11/11/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
ABSTRACT Comparison between bronchoscopy guided and real time ultrasound guided percutaneous tracheostomy using Griggs technique.
INTRODUCTION Percutaneous tracheostomy is usually performed in critically ill patients in intensive care units. It is usually done under fiber optic guidance to allow needle insertion while protecting the real wall damage and to verify cannula location. However, requirement of specialized equipment and staff with specific experience experience, together with possibility of acutely elevated intracranial pressure limits the use of fiber optic in acute brain damage patients. The use of ultrasound guidance for percutaneous tracheostomy has increased recently with advanatge of portability,safety,pain free , identification of thyroid gland and vascular structures, determination of correct tracheal space and guidance of needle into trachea. Objectives of our study is to compare efficacy, time taken for each procedure, no of needle puncture attempt, complications and evaluate their accuracy which is defined by wheter puncture is at the centre, site puncture space and visualization of Griggs forcep tip in the space.
MATERIALS AND METHOD: The study will include 60 patients, 30 in each group. Primary outcome: total time taken by each procedure. Secondary outcome: compare no of needle puncture attempts incidence of complications and accuracy. Accuracy is defined by wheter puncture is at centre, puncture space and visualization of griggs forcep tip in the space.
RESULT: The above parameters will be recorded and compared.
|