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临床试验/CTRI/2024/02/063146
CTRI/2024/02/063146招募中3 期

Change in PPV with Tidal Volume Challenge to assess fluid responsiveness in patients suffering from Acute Respiratory Distress Syndrome undergoing low tidal volume mechanical ventilation in prone position

Tata Memorial Hospital, Mumbai1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月4日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
To assess whether change in PPV while transiently increasing tidal volume to 8ml per kg Predicted Body Weight in patients suffering from ARDS undergoing low tidal volume ventilation in prone position adequately predicts fluid responsiveness.

研究概览

简要总结

Patients admitted in ICU with septic shock (spread of infection in blood) caues low blood pressure. The first line of treatment for this is administration of intraveous fluids called as Fluid therapy. This fluid therapy, which involves the rapid administration of fluids in the patient’s veins, stands as one of the fundamental treatment modalities employed in patients afflicted by low blood pressure stemming from infection, otherwise known as septic shock. However, it is worth noting that only a minority of patients, specifically 50%, exhibit a positive response to fluid therapy, evidenced by an increase in blood pressure and an amelioration of blood supply to various organs, consequently averting the onset of organ failure.

In cases where patients display an unresponsiveness to fluid therapy, the administration of fluids may result in deleterious consequences, such as fluid accumulation within the lungs, which can precipitate lung congestion, thereby exacerbating the patient’s oxygen requirement. Consequently, the ability to accurately predict fluid responsiveness assumes paramount importance in the effective management of patients. In light of this, several tests have been devised with the aim of forecasting which patients will exhibit a favorable response to fluid therapy. However, the challenge lies in those patients who are placed in a prone position, that is, made to lie on their stomach for the purpose of ventilation, as part of their lung problems treatment. This specific group of patients presents a unique issue due to the lack of standardized tests available and the technical difficulties encountered when attempting to perform the existing tests.

To evaluate the effectiveness of the tidal volume challenge test, we are currently investigating one specific test. This test involves making adjustments to the ventilator settings in order to regulate the amount of breath administered to the patient. The breath volume is adjusted from 6ml/kg weight to 8ml/kg weight, and the test is conducted for a duration of 1 minute. The objective of this test is to observe the response in pulse pressure. Additionally, we will also assess the impact of administering fluids on the patient’s heart function. This will allow us to determine whether the reliability of pulse pressure variation (PPV) improves after measuring it following an increase in breath volume to 8ml/kg. By conducting this study, we aim to determine whether the change in PPV, while transiently increasing tidal volume to 8ml/kg Predicted Body Weight (PBW) in patients suffering from Acute Respiratory Distress Syndrome (ARDS) undergoing low tidal volume ventilation in the prone position, sufficiently predicts fluid responsiveness.

In order to examine the impact of lung compliance on the accuracy and reliability of the tidal volume challenge test, which aims to predict fluid responsiveness in patients who are experiencing acute respiratory distress syndrome (ARDS) and are undergoing low tidal volume ventilation in the prone position, it is crucial to thoroughly investigate the outcomes of this test. If the test produces favorable and encouraging results, it could potentially serve as a valuable and beneficial tool in the management and treatment of patients who are similar to yours, ultimately leading to improved patient care and outcomes.

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

  • 1 Adult patients Age more than 18 years 2 Suffering From Acute Respiratory Distress Syndrome ARDS defined as per Berlins Criteria.
  • 3 Undergoing mechanical ventilation via lung protective low tidal volume strategy using Volume assist control ventilation without any spontaneous breathing activity (deeply sedated/ paralyzed as seen on pressure time curve on ventilator), in prone position.
  • 4 Having invasive continuous cardiac output monitoring using PICCO device (Pulsion Medical Systems, Feldkirchen, Germany) with Phillips Intel View monitor MP700 5 Patients of acute circulatory failure defined as the presence of systolic blood pressure (SBP) less than or equal to 90 mm Hg or mean arterial pressure (MAP) less than or equal to 70 mm Hg or requiring vasopressors to maintain SBP more than 90 or MAP more than 70 along with one or more of the following: a) urine flow less than 0.5 mL per kg per hr for more than 2hours.
  • b) heart rate more than 100 beats per minute.
  • c) Presence of skin mottling d) blood lactate concentration more 2 mmol per L in whom the treating physician plans to give a fluid bolus.

排除标准

  • 1 Age less than 18 years.
  • 2 Patients with cardiac arrythmia, known valvular heart disease, intracardiac shunt, right ventricular dysfunction, air leakage through chest drains, abdominal compartment syndrome.
  • 3 Pregnant Females 4 Patient refusing consent to participate in the study 5 Extravascular Lung water Index (EVLWI) >12 (except in those patients in whom treating clinician wishes to give a fluid bolus to the patient).

结局指标

主要结局

To assess whether change in PPV while transiently increasing tidal volume to 8ml per kg Predicted Body Weight in patients suffering from ARDS undergoing low tidal volume ventilation in prone position adequately predicts fluid responsiveness.

时间窗: 30 min after starting the intervention

次要结局

  • To study the effect of lung compliance on the validity of tidal volume challenge test to predict fluid responsiveness in patients suffering from ARDS undergoing low tidal volume ventilation in prone ventilation.(1 months after starting the trial enrollment)

研究者

发起方
Tata Memorial Hospital, Mumbai
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sheila N Myatra

Tata Memorial Hospital, Mumbai

研究点 (1)

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