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CTRI Number  CTRI/2024/04/066521 [Registered on: 30/04/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study
Modification(s)  
Prospective observational study 
Study Design  Other 
Public Title of Study   Determining the accuracy of ultrasound in detecting airway burns 
Scientific Title of Study   Evaluation of Diagnostic Accuracy of Airway Ultrasound for Inhalational Burn Injury 
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 Aditya Gaurang Tolat 
Designation  Senior Resident (MCH) 
Affiliation  All India Institute of Medical Sciences, Delhi 
Address  Department of plastic, reconstructive and burns surgery, All India Institute of Medical Sciences, Delhi

South
DELHI
110029
India 
Phone  7262893941  
Fax    
Email  adityatolat@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Maneesh Singhal 
Designation  Professor and Head, Department of Plastic, Reconstructive and Burns Surgery 
Affiliation  All India Institute of Medical Sciences, Delhi 
Address  Department of Plastic, Reconstructive and Burns Surgery, All India Institute of Medical Sciences, Delhi

South
DELHI
110029
India 
Phone  9810373345  
Fax    
Email  drmaneesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Maneesh Singhal 
Designation  Professor and Head, Department of Plastic, Reconstructive and Burns Surgery 
Affiliation  All India Institute of Medical Sciences, Delhi 
Address  Department of Plastic, Reconstructive and Burns Surgery, All India Institute of Medical Sciences, Delhi

South
DELHI
110029
India 
Phone  9810373345  
Fax    
Email  drmaneesh@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Delhi 
Address  All India Institute of Medical Sciences, Delhi 110029 
Type of Sponsor  Government medical college 
 
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 Aditya Tolat  All India Institute of Medical Sciences, Delhi  Depratment of Plastic, Reconstructive and Burns Surgery, All India Institute of Medical Sciences, Delhi 110029
South
DELHI 
7262893941

adityatolat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences, Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T273||Burn of respiratory tract, part unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients above 18 years of age
2. Patients undergoing evaluation for burn management with evidence of inhalational
injury presenting primarily to our centre. 
 
ExclusionCriteria 
Details  1. Patients below 18 years of age.
2. Patients who are not undergoing management for burns or those without evidence of
inhalational injury
3. Patients not willing to participate in the study
4. Threatened airway requiring emergency intubation
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Diagnosis of Airway edema  At admission and at 24 hours after admission 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of accuracy of Ultrasound with Fibreoptic bronchoscopy in detecting inhalation injury.  At admission & at 24 hours after admission 
 
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   N/A 
Date of First Enrollment (India)   10/05/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Aims and objective

Primary objective â€“ To correlate the findings of ultrasonography with fiberoptic bronchoscopy in patients with suspected inhalational injury

Secondary objective

  1. To identify airway edema

  2. To identify the need for intubation in patients with suspected inhalational injury using

    ultrasound

    Type of study: A Prospective Correlational Observational Trial 

    Duration of study: Cases will be taken up till sample size is achieved

    Sample size : Since this study has not been done before, the study will be done as a pilot on 50 patients.

    Place of study: The study will be conducted at the Department of Anaesthesiology ,Pain Medicine and Critical care ,All India Institute of Medical Sciences , New Delhi.

    Inclusion criteria

    1. Age >18 years

    2. Patients presenting to burns emergency with inhalational/ suspected inhalational

      injury

      Exclusion criteria

      1. Refusal to consent

      2. Patients requiring urgent intubation in view of threatened airway

      3. Associated airway or maxillofacial trauma

      Consent: Consent for the study will be obtained as per the Declaration of Helsinki. The patients will be well informed and explained in their language that they are participating in a study. They will be explained in person and written consent will be obtained from the patient. Patients will be made aware of their right to withdraw from the study at any time without any adverse effects on their clinical care.

      Randomisation: Randomisation can not be ensured due to the nature of presentation of the cases.

      Blinding: Two separate anaesthesiologists will be doing the airway assessments. One anaesthesiologist will conduct the airway examination and fibreoptic bronchoscopy. The second anaesthesiologist will be doing the ultrasound of the airway and will be unaware of the airway and FOB findings.

      Methodology

      After obtaining written informed consent, the patient’s baseline hemodynamic parameters will be noted. Oral and nasal cavity will be examined for the presence of any soot, mucosal ulcerations and erythema, singed nasal hair. Symptoms like dyspnea, hoarsness, stridor will be observed. Requirement of oxygen will be noted.

      A bedside point of care ultrasound (Sonosite©) of the airway will be done by an experienced anesthesiologist at the initial presentation to the intensive care unit using a high frequency linear transducer (5-12 MHz). The person doing the ultrasound will be unaware of the airway

      findings on general examination and FOB. The patient will be lying supine with neck slightly extended with spontaneous breathing. Transverse and longitudinal scan will be done from the submandibular region till the tracheal rings in a sequential manner with specific focus on the region above and below the thyroid cartilage.

      The vocal cords will be identified and confirmed by patient phonation. External identification of the thyroid cartilage by physical exam should guide placement of the ultrasound transducer in the transverse plane at the level of the thyroid cartilage. The transducer will then be slid superiorly and inferiorly in the transverse plane until the vocal cords are clearly identified. Evaluation of the vocal cords will be done at rest and during phonation. This region, along with the regions above and below the vocal cords from the submandibular region to the base of the neck will be interrogated for asymmetry.

      In the longitudinal scan the transducer will be placed vertically at 1–1.5 cm medial and aligned to the lateral surface of thyroid cartilage lamina where the arytenoid cartilage will be in the back of the oblique line of thyroid cartilage. The transducer will be applied at the right and left sides of the thyroid cartilage lamina and the right and left arytenoid cartilage and anteroposterior and craniocaudal diameters will be observed separately. (13)

      The false vocal cords, arytenoids and true vocal cords will be identified. The presence of airway edema will be evaluated by measuring the laryngeal air column width, tracheal wall thickness, thickness of the vocal cords, arytenoids for false vocal cord fullness, the inter- arytenoid distance using ultrasound caliper method.

      The findings will then be correlated with using fiberoptic bronchoscopy in the patient using airway preparation and sedation. FOB will be done by an anesthesiologist not participating in the USG examination and will be blinded to the USG findings. The fiberoptic grading will be done according to the FOB classification of inhalation injury: prediction of acute lung injury.(14)

      Negative G0

      1. G1  Mild edema and hyperemia, with or without carbon soot

      2. G2  Severe edema and hyperemia, with or without carbon soot

      3. G3  Ulcerations, necrosis, absence of both cough reflex and bronchial secretions (dry)

 
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