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临床试验/CTRI/2024/08/072553
CTRI/2024/08/072553尚未招募4 期

Comparative analysis of diaphragmatic thickness fraction with parasternal muscle thickness fraction by the use of ultrasonography for predicting weaning in adults receiving mechanical ventilation.

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Comparison of diaphragmatic thickness with parasternal muscle thickness using ultrasonography for

研究概览

简要总结

Mechanical ventilation has emerged as commonly used tool in saving lives of patients experiencing heightened work of breathing with altered pulmonary gas exchange for effective ventilation and oxygenation.

Weaning is the process of gradually reducing ventilator assistance so that spontaneous respiration can be restored.

Traditionally ventilator derived factors like the

RSBI (rapid shallow breathing index),

Tracheal occlusion airway pressure,

NIF (negative inspiratory force) index and

other indices, along with clinical criteria that monitor the respiratory rate and oxygenation, have been studied and often utilized to guide successful weaning.

Recently ultrasound guided parameters are being used. USG guided measurement of diaphragmatic and parasternal muscle thickness being the most widely used index.

Conduct Of Study

Once the weaning criteria has been attained, patients will be subjected to recording of conventional ventilator derived parameters which are rapid shallow breathing index (RSBI), Negative inspiratory Force (NIF) and Occlusion Pressure (P0.1), RSBI values less than 105, NIF values less than or equal to 25, occlusion pressure value less than 4.2cm H2O as well as ultrasound derived diaphragmatic and parasternal parameters to predict the successful weaning.

All the parameters will be recorded from the day a particular patient is initiated on CPAP/ASB mode of ventilation. All the ultrasonography parameters will be noted twice a day and ventilator derived parameter will be noted once a day starting from day of weaning to complete discontinuation of mechanical ventilation for at least 24 hours which will be considered as successful weaning.

In the ultrasound guided intervention diaphragm thickness and parasternal thickness derived parameters will be recorded twice a day. Each time mean of three readings of diaphragm and parasternal derived parameters will be taken in the observations.

The number of patients requiring reintubation will also be noted. At the end of study, the data will be decoded and analyzed accordingly.

Technique of diaphragm ultrasound:

All the Diaphragmatic ultrasounds in ICU will be performed by an experienced anesthesiologist using high frequency linear array probe of 6 to 12 MHz.

The probe will be placed in the right subcostal margin between the mid clavicular and anterior axillary line, parallel to the excursion of the diaphragm.

2D B mode will be used to search the line of right hemidiaphragm.

The diaphragmatic excursions will be measured in M mode from baseline to point of maximum height of inspiration at the zone of apposition of diaphragm and rib cage.

Diaphragm thickness will be measured in the zone of apposition of the diaphragm and rib cage in the mid axillary line between the eighth and tenth intercostal space by placing the curvilinear probe allowing placement of M mode line parallel to the excursion of the diaphragm.

MEASUREMENTS:

Following observations will be drawn from the diaphragm ultrasound:

1 Diaphragm thickness at end of inspiration and expiration

2 Amplitude AMP in centimeters will be measured.

3 The diaphragm thickness fraction in percentage will be calculated as the difference between diaphragm thickness at inspiration and diaphragm thickness expiration divided by diaphragm thickness at expiration multiply by 100.

Technique of parasternal ultrasound

An ultrasound of the second intercostal muscle ultrasound will be performed.

The thickness of parasternal intercostals will be calculated with a high frequency of 6to 12 MHz USG probe at the level of the second intercostal space, 6 to 8 cm away from the sternal edge to visualize the second and third ribs.

Then, M-mode will be used to measure the thickness at the end of inspiration and expiration. The average of three consecutive readings will be used for analysis.

The maximum and minimum thickness of the parasternal intercostals during three consecutive tidal breaths will be taken and averaged.

Then, the PICTF in percentage will be calculated using the following formula: Maximum–minimum thickness/minimum thickness, expressed as a percentage. All the respiratory muscle analysis will be done after a 120 minute SBT. PICTF percentage will be measured as peak thickness at inspiration minus end-expiratory thickness divided by end-expiratory thickness multiply by 100.

All the observations will be noted in the prescribed performa. Utrasound derived diaphragmatic and parasternal factors used for weaning will be noted and comapritive analysis between the two will be done.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • All the patients with age more than 18 years patients receiving mechanical ventilation in process of weaning from the same.

排除标准

  • Patients with following will be excluded from the study Diaphragmatic paralysis/injury, neuromuscular disease, pregnant women, lactating/nursing mothers Patients aged less than 18 years.
  • Received mechanical ventilation for less than 24 hrs.
  • Preexisting diaphragm disease.
  • Any breach in skin preventing DUS examination in subcostal area.
  • Phrenic nerve palsy.
  • Refusal of consent.

结局指标

主要结局

Comparison of diaphragmatic thickness with parasternal muscle thickness using ultrasonography for

时间窗: From starting of weaning process at predefined time intervals every day twice moring and evening till 24 hours post successful extubation diaphragmatic and parasternal muscle thickness will be measured using ultrasound. | 3 readings each in morning and evening will be taken for both diaphragmatic and parasternal muscle thickness.

predicting weaning in patients receiving mechanical ventilation in ICU

时间窗: From starting of weaning process at predefined time intervals every day twice moring and evening till 24 hours post successful extubation diaphragmatic and parasternal muscle thickness will be measured using ultrasound. | 3 readings each in morning and evening will be taken for both diaphragmatic and parasternal muscle thickness.

usg measured diaghragmatic muscle thickess fraction and parasternal thickness fraction will be measured and the outcomes of two will be compared in all patients

时间窗: From starting of weaning process at predefined time intervals every day twice moring and evening till 24 hours post successful extubation diaphragmatic and parasternal muscle thickness will be measured using ultrasound. | 3 readings each in morning and evening will be taken for both diaphragmatic and parasternal muscle thickness.

次要结局

  • 1. To measure diaphragm movement derived parameters i.e .Amplitude [AMP] in centimeters((cm), thickness of muscle during inspiration and expiration.)

研究者

发起方
Government Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Arushi Sharma

Govt Medical College and Hospital

研究点 (1)

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