| 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
|
|
|
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
|
|
|
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 – To correlate the findings of ultrasonography with fiberoptic bronchoscopy in patients with suspected inhalational injury Secondary objective To identify airway edema 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 Age >18 years Patients presenting to burns emergency with inhalational/ suspected inhalational injury
Exclusion criteria Refusal to consent Patients requiring urgent intubation in view of threatened airway 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 G1 Mild edema and hyperemia, with or without carbon soot G2 Severe edema and hyperemia, with or without carbon soot G3 Ulcerations, necrosis, absence of both cough reflex and bronchial secretions (dry)
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