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临床试验/CTRI/2024/04/066521
CTRI/2024/04/066521尚未招募不适用

Evaluation of Diagnostic Accuracy of Airway Ultrasound for Inhalational Burn Injury

All India Institute of Medical Sciences Delhi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Diagnosis of Airway edema

研究概览

简要总结

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 traumaConsent: 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)

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients above 18 years of age
  • Patients undergoing evaluation for burn management with evidence of inhalational injury presenting primarily to our centre.

排除标准

  • Patients below 18 years of age.
  • Patients who are not undergoing management for burns or those without evidence of inhalational injury
  • Patients not willing to participate in the study
  • Threatened airway requiring emergency intubation.

结局指标

主要结局

Diagnosis of Airway edema

时间窗: At admission and at 24 hours after admission

次要结局

  • Comparison of accuracy of Ultrasound with Fibreoptic bronchoscopy in detecting inhalation injury.(At admission & at 24 hours after admission)

研究者

发起方
All India Institute of Medical Sciences Delhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Aditya Gaurang Tolat

All India Institute of Medical Sciences, Delhi

研究点 (1)

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