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临床试验/CTRI/2021/01/030617
CTRI/2021/01/030617招募中不适用

Ultrasonographic assessment of diaphragmatic muscle thickness and diaphragmatic thickness fraction in intensive care unit (ICU) patients and evaluation of modified Nutritional Risk in Critically Ill (mNUTRIC) score as a risk factor- a prospective observational study

Department of Respiratory Therapy Manipal Academy of Higher education Manipal1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月26日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Rate of change of diaphragm muscle thickness and diaphragmatic thickness fraction (DTF) over time in the patients on various levels of respiratory support, and its association with mNUTRIC score.

研究概览

简要总结

On the day of admission to theICU, the mNUTRIC score will be calculated. The patients will be either onoxygen therapy devices like face mask, venturi devices, non-rebreathing bagmask (NRBM), non-invasive ventilation (NIV) or on invasive mechanicalventilation (IMV). Diaphragm muscle thickness and diaphragmatic thicknessfraction (DTF) will be evaluated on the right hemi-diaphragm on day odadmission to ICU ie day 0, day 3, day 7 in ICU. Ultrasound imaging will be donewith B- mode ultrasound with linear transducer probes. With the patients being30-degree head up as usually in the ICU, the linear transducer will be placedperpendicularly on the right chest wall, between the anterior axillary andmid-axillary lines, between 8-10 intercostal space, at the zone of appositionbetween pleura and diaphragm. Measurements of diaphragm muscle thickness willbe done three times at end-expiration, and the mean value will be recorded.Similarly DTF will be evaluated 3 times, and the mean value will be recorded.

Diaphragmatic ThicknessFraction(DTF) = Thickness at end inspiration- Thickness at end expiration/Thickness at end expiration

  On the days 1,3,7 of ICU stay, lung ultrasound will bedone after ultrasonographic evaluation of both lungs, and scoring will be doneas under

Lung Ultrasound Scoring

Point for each lung  ultrasound score

Degree of lung aeration

Pattern

|0 point

Normal

A lines

|1 point

Moderate loss of aeration

Well separated B lines

|2 point

Severe loss of aeration

Coalescent B lines

|3 point

Complete loss of aeration

Lung Consolidation

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 admitted to critical care unit and on oxygen support with either invasive ventilation/Non- invasive ventilation ( NIV) / high flow nasal cannula (HFNC) /non rebreathing mask (NRBM) /venturi devices as deemed suitable by ICU consultant.

排除标准

  • 1.Patients with known neurological disorders.
  • 2.Patients with any form of myopathies.
  • 3.Patients with chest trauma 4.Patients have any abdominal surgeries in the last 2 months.
  • 5.Any patient with known phrenic nerve disorders 6.Post nerve blocks which can alter phrenic nerve function like interscalene or supraclavicular brachial plexus blocks.

结局指标

主要结局

Rate of change of diaphragm muscle thickness and diaphragmatic thickness fraction (DTF) over time in the patients on various levels of respiratory support, and its association with mNUTRIC score.

时间窗: on day of admission, day three and day seven

次要结局

  • worst P/F ratio, lung ultrasound scores (LUS), days of ventilation on face mask/venturi/NRBM/NIV/IMV, outcome of ICU stay.(on day of admission, day 3 and day 7)

研究者

发起方
Department of Respiratory Therapy Manipal Academy of Higher education Manipal
申办方类型
Private medical college

研究点 (1)

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