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临床试验/CTRI/2026/04/107331
CTRI/2026/04/107331尚未招募不适用

Prospective observational cohort to predict accuracy of Peripheral Perfusion Index, Respiratory Adjusted Shock Index and Reverse Shock Index in predicting Occult Hypoperfusion in Trauma patients

Shivangi Sharma1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年4月15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
150
试验地点
1

研究概览

简要总结

Primary Objective

To evaluate the predictive accuracy of the Peripheral Perfusion Index (PPI), Respiratory Adjusted Shock Index (RASI), and Reverse Shock Index (RSI) for identifying occult hypoperfusion (defined by a serum lactate level > 2 mmol/L or a base deficit <-2 mEq/L) in trauma patients upon arrival at the casualty.

Secondary Objectives

1.To compare the predictive performance of each index (PPI, RASI, and RSI) against the traditional Shock Index (SI) in detecting occult hypoperfusion.

2.To determine the optimal cut-off values for PPI, RASI, and RSI that best predict occult hypoperfusion and adverse clinical outcomes (e.g., need for massive transfusion, ICU admission, mechanical ventilation, or mortality).

PLACE OF STUDY:

This study will be conducted in Ganga Medical Center and Hospital, Coimbatore Level I trauma centre which manages a high volume of severely injured patients

Methodology:

Upon arrival at the trauma bay, the following data would be collected:

Standard vital signs (heart rate, systolic blood pressure, respiratory rate).

Clinical indices (PPI, RASI, and RSI) would be calculated or measured.

Injury characteristics and mechanism of injury.(ISS, RTS)

Simultaneously, point of care lactate levels will be measured by drawing a blood sample within 15-20 minutes of arrival to Trauma Bay

Measurements will be taken pre and post operatively .

Outcomes would be recorded post operatively will also include:

1.Need for massive transfusion protocol activation pre/intra/post operatively

2.Length of stay in the Intensive Care Unit (ICU) and hospital.?

3.Incidence of complications (e.g., acute kidney injury, acute respiratory distress syndrome).

4.Mortality.

5.Post op lactate values indices

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1.The study will include adult trauma patients (aged 18 years- 75 years) 2.Trauma patients ASA Grade I and II 3.Vitals recordable 4.Open injury.

排除标准

  • 1.Age <18 yrs 2.Trauma patients with ASA III and IV 3.Vitals not recordable 4.Closed injuries 5.Traumatic arrest/ Overt shock 6.Patients will be excluded if they have a known history of severe cardiac or pulmonary disease, are pregnant, present in frank cardiac arrest, or have received blood products or significant vasopressor medications in the pre-hospital setting.
  • 7.Patients with isolated traumatic brain injury without evidence of systemic trauma will also be excluded.

研究者

发起方
Shivangi Sharma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shivangi Sharma

Ganga Hospital and Medical Centre

研究点 (1)

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