FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/100354 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 03/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Treatment]  
Study Design  Other 
Public Title of Study   Comparison of combined use of Fiberoptic Bronchoscopy and Neck Ultrasound versus Fiberoptic Bronchoscopy alone in terms of procedural dynamics and complications during Percutaneous Dilatational Tracheostomy in Adult ICU Patients-a Randomised Open Label Study 
Scientific Title of Study   Comparison of combined use of Fiberoptic Bronchoscopy and Neck Ultrasound versus Fiberoptic Bronchoscopy alone in terms of procedural dynamics and complications during Percutaneous Dilatational Tracheostomy in Adult ICU Patients-a Randomised Open Label Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr POOJA SINGH 
Designation  PG RESIDENT 
Affiliation  Dr. S.N. Medical College Jodhpur 
Address  Department of Anaesthesia, Dr. S.N. Medical College, Jodhpur, Rajasthan, 342003

Jodhpur
RAJASTHAN
342003
India 
Phone  9479042583  
Fax    
Email  poojasingh960@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SHIKHA SONI 
Designation  PROFESSOR 
Affiliation  Dr. S.N. Medical College Jodhpur 
Address  Dr. S.N. Medical College, Jodhpur, Rajasthan, 342001

Jodhpur
RAJASTHAN
342001
India 
Phone  9950198704  
Fax    
Email  shikhasoni.19@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SHIKHA SONI 
Designation  PROFESSOR 
Affiliation  Dr. S.N. Medical College Jodhpur 
Address  Dr. S.N. Medical College, Jodhpur, Rajasthan, 342001

Jodhpur
RAJASTHAN
342001
India 
Phone  9950198704  
Fax    
Email  shikhasoni.19@gmail.com  
 
Source of Monetary or Material Support  
Dr. S.N Medical College, Shastri Nagar, Jodhpur, Rajasthan, 342001 
 
Primary Sponsor  
Name  Dr POOJA SINGH 
Address  PG GIRLS HOSTEL NO.3, GATE NO.4, MDM HOSPITAL, SHASTRI NAGAR, JODHPUR, RAJASTHAN, 342003, INDIA 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr POOJA SINGH  Dr. S.N. Medical College, Jodhpur  DEPARTMENT OF ANAESTHESIA, DR. S.N. MEDICAL COLLEGE, SHASTRI NAGAR, JODHPUR, RAJASTHAN, INDIA,342001
Jodhpur
RAJASTHAN 		 9479042583

poojasingh960@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee SN Medical College, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J962||Acute and chronic respiratory failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fiberoptic bronchoscopy and neck ultrasound versus fiberoptic bronchoscopy alone  Fiberoptic bronchoscopy and neck ultrasound versus fiberoptic bronchoscopy alone undergoing PDT in Adult ICU patients. 
Intervention  Percutaneous Dilatational Tracheostomy  Percutaneous Dilatational Tracheostomy in Adult ICU Patients 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All Haemodynamically stable patients of age 18-60 yrs admitted to the ICU undergoing elective PDT. 
 
ExclusionCriteria 
Details  Patient/relative refusal, short neck, thyroid goitre, cervical trauma, history of previous neck or radiation surgery, infection at the puncture site. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Procedural dynamics
1. total procedure time(mins)
2. No. of needle puncture attempts
3. Time taken for Dilatation(sec/min)
4. Attempt to insert Tracheostomy tube
5. Ease of procedure

Intraprocedural and postprocedural complications( bleeding desaturation, hypotension, bradycardia, pneumothorax) 		 Procedural dynamics
1. total procedure time(mins)
2. No. of needle puncture attempts
3. Time taken for Dilatation(sec/min)
4. Attempt to insert Tracheostomy tube
5. Ease of procedure

complications within 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3 
Date of First Enrollment (India)   14/01/2026 
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="5"
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   My thesis topic is comparison of combined use of fiberoptic bronchoscopy and neck ultrasound versus fiberoptic bronchoscopy alone in terms of procedural dynamics and complications in percutaneous dilatational tracheostomy in adult ICU patients. its a randomised open label study. all hemodynamically stable adult patients of age group 18-60 yrs will be recruited for study and after preprocedural evaluation done will be randomised into two equal groups and interventional study will be done and results will be observed for 24 hours and data compilation will be done via the use of student t test and reporting will be done. 
Close