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CTRI Number  CTRI/2025/03/081860 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Diagnostic
Preventive
Screening
Dentistry 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   STUDY OF DEEP NECK SPACE INFECTIONS– ROLE OF CT AND ULTRASOUND 
Scientific Title of Study   Study of deep neck space infections of patients presenting to Ent department Govt medical College, Cuddalore – Role of Ct and Ultrasound 
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 choudhary satyanarayana chalasani 
Designation  Assistant professor Ent 
Affiliation  Govt medical College and Hospital CuddaloreAnnamalai university 
Address  Room 202, Ent Opd, Govt Medical College and Hospital, Cuddalore, Annamalai nagar, Chidambaram.
Annamalai nagar, chidambaram
Cuddalore
TAMIL NADU
608002
India 
Phone  9502191823  
Fax  04144238499  
Email  cvschoudhary@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Choudhary satyanarayana chalasani 
Designation  Assistant professor ENT 
Affiliation  Annamalai university 
Address  Room 202, Ent Opd, Govt Medical college and Hospital, Cuddalore. Chidambaram
Annamalai nagar, chidambaram
Cuddalore
TAMIL NADU
608002
India 
Phone  9502191823  
Fax  04144238499  
Email  cvschoudhary@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr choudhary satyanarayana chalasani 
Designation  Assistant professor ENT 
Affiliation  Govt Medical College and Hospital, Cuddalore 
Address  Room 202, Ent dept, Govt Medical College and Hospital, Cuddalore Annamalai nagar, Chidambaram.
Annamalai nagar, chidambaram
Cuddalore
TAMIL NADU
608002
India 
Phone  9502191823  
Fax  04144238499  
Email  cvschoudhary@yahoo.co.in  
 
Source of Monetary or Material Support  
Room 202, Ent Opd, Govt Medical College and Hospital, Cuddalore. Chidambaram. TamilNadu. India. Pincode 608002 
 
Primary Sponsor  
Name  Dr choudhary Satyanarayana chalasani 
Address  1424, 4th cross, Annamalai nagar, Chidambaram. cuddalore District. Annamalai nagar, chidambaram 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Choudhary Satyanarayana Chalasani  Govt medical college and hospital cuddalore  Annamalai Nagar. Chidambaramram, Cuddalore District. Tamilnadu. India. Pincode-608002
Cuddalore
TAMIL NADU 		 9502191823
04144238499
choudharychalasani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human ethics committee, Raja Muthiah Medical college and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K113||Abscess of salivary gland, (2) ICD-10 Condition: A318||Other mycobacterial infections, (3) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, (4) ICD-10 Condition: B950||Streptococcus, group A, as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Preoperative/screening ultrasound neck and CTScan Neck at admission and treatment within 5 days  The deep neck infections are usually limited to one or two neck spaces. But involvement of the multiple vertical neck spaces and size greater than 3 cms can lead to rapid spread of infections and increased mortality. CT scanning helps diagnose the involvement of such spaces while ultrasound and study of echo pattern of tissues helps localize the infections. 
Comparator Agent  UTRASOUND NECK at time 0. Admission  The role of ultrasound in localising the Deep neck space is evaluated and compared to patient undergoing a CT scan later 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  All patients presenting to ENT dept with deep neck infections with symptoms of pain, swelling, difficulty swallow and difficulty breathing.
Fasciitis and acute lymph node infections involving deep cervical nodes and presenting as neck swelling.

 
 
ExclusionCriteria 
Details  1.Neck infections as a result of Malignancy.
2.Infections involving congenital Cysts and Fistulas.
3.Patients refusing treatment and referred elsewhere are excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Computerised tomography and Ultrasound at the time of presentation and within 5 days in the early disease and in determining the extent of the disease. Its use to help initiate early intervention with IV antibiotics and as guide for surgical drainage helps to successful management of such infections. Patients who present with symptoms indicative of Deep Neck infections are subject to Radiological investigation and those patients not responding to IV antibiotic therapy are subject to surgery  Early intervention with IV antibiotics and Insulin within 5 days and CT Scan and Ultrasound as a guide for surgical drainage helps to successful management of such infections. Patients who present with symptoms and those patients not responding to IV antibiotic therapy are subject to surgery. Treatment failure considered at end of 1 week, 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Involvement of multiple deep neck spaces has been attributed to poor prognosis and outcomes such as sepsis and death. Number of vertical and horizontal neck spaces is evaluated and patient outcomes are measured  2 weeks  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   25/03/2025 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [choudharychalasani@gmail.com].

  6. For how long will this data be available start date provided 15-12-2025 and end date provided 15-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   We aim to study the radiological features of Deep Neck space infections (DNI) and pattern of spread of infection and draw a correlation of duration of stay in hospital to number of deep neck spaces involved. Study aims to investigate the role of patient variables such as age, diabetes and level of neck infection to duration of stay and mortality. Prior studies have revealed the predictive value of mediastinal involvement to poor prognosis and role of early surgical intervention vs IV antibiotic therapy in reduced hospital stay and better prognosis. Future implications include role of Artificial intelligence as a predictor of patient prognosis with input of radiological data from stored dicom information. Many hospitals lack radiologist and specialist capable of dealing with complicated Deep neck infection and our study will provide valuable inputs to rural physician to seek early referral of such risk patients 
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