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临床试验/CTRI/2026/02/103316
CTRI/2026/02/103316尚未招募不适用

Prospective insights into diaphragmatic function and weaning outcomes in mechanically ventilated ICU patients: A Point of Care ultrasound approach

Dr Robin Manidas1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2026年2月20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
160
试验地点
1

研究概览

简要总结

Study title and design

Prospectie longitudinal obserational study assessing diaphragmatic function using point of care ultrasound in mechanically ventilated adult ICU patients

Objectives

To evaluate serial changes in  diaphragmatic thickness thickening fraction and excursion during the first 5 ICU days

Compare the effects of volume controlled versus pressure controlled ventilation

Study the association between driing pressure and diaphragmatic dysfunction and determine whether early diaphragmatic dysfunction predicts difficult or prolonged weaning

Rationale

Mechanical ventilation is associated with ventilator induced diaphragmaic dysfunction which contritubes to delayed weaning prolonged ICU stay and worse clinical outcomes

There is limited prospective Indian data describing the trajectory of diaphragmatic function during mechanical ventilation and its impact on weaning outcome

This study aims to address this gap and support early risk stratification and optmisation of of ventilator strategies

Participants

Adult patients aged 18 years and above requiring  invasive mechanical ventilation for more than 72  hours with ICU stay atleast 5 days

Patient with pre existing neuromuscular disease diaphramatic pathology technical limitation to ultrasound or refusal of consent will be excluded

MethodsEligible patients will be enrolled within 24 hours of initiation of mechanical ventilation. Baseline demographic data illness severity score SOFA and APACHE II ventilator parameter laboratory values and nutritional intake will be recorded daily.Daily point of care ultrasound assessments from day 1  to day 5 will include diaphragmatic thickness thickening fraction, excursion tissue doppler indices and peripheral muscle thickness.Weaning outcomes duration of ventilation ICU length of stay and mortality will be documented. No additional interentions or biological sampling will be perfomed.Outcomes

The primary outcome is the rate of change in diaphragmatic function over the first 5 days of mechanical ventilation

Secondary outcomes include the effect of ventilatory mode and driving pressure on diaphragmatic function prediction of weaning outcomes and  correlation  with  duration of ventilation ICU stay mortality and peripheral muscle  wasting

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 who are admitted to intensive care units and require Invasive mechanical ventilation for greater than 72 hours.

排除标准

  • 1.Patient ventilated for less than 72 hours.
  • 3.Pre-existing neuromuscular disorders affecting respiratory muscles.
  • 4.Known diaphragmatic paralysis or prior diaphragmatic surgery/trauma 5.Patients in whom acquisition of reliable diaphragmatic ultrasound images is difficult.
  • 6.Pneumothorax or active large pleural effusion or pregnancy preventing diaphragm assessment.

研究者

发起方
Dr Robin Manidas
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Robin Manidas

Kasturba Medical College, Manipal

研究点 (1)

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