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临床试验/CTRI/2023/01/049278
CTRI/2023/01/049278尚未招募4 期

"Comparison of Airway Pressure Release Ventilation versus Pressure Regulated Volume Control mode of ventilation in the exploratory laparotomy patients in intensive care unit"

Director Principal1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年1月31日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
110
试验地点
1
主要终点
Ventilatory parameters: Peak airway pressure (Ppeak), plateau pressure (Pplat), mean airway pressure (Pmean), compliance (C), static compliance (Cstat), airway resistance (Raw) will be recorded

研究概览

简要总结

Mechanical ventilation is applied as one of the life support interventions in post-surgical patients with acute respiratory failure in the intensive care unit. Mechanical ventilators are equipped with unique modes to achieve optimum cardiopulmonary functions. With various preset target values, the advanced modes automatically adjust according to the patient‘s mechanical and ventilatory parameters, hence known as closed-loop control modes. Airway pressure release ventilation (APRV) is designed to facilitate the constant recruitment of alveoli while reducing the probability of ventilator-induced lung injury; while Pressure-regulated volume control (PRVC) is a dual mode of mechanical ventilation that integrates volume and pressure-control ventilation and is also termed as volume-targeted synchronized mode. On search of literature, no previous studies have compared APRV with more establish PRVC mode of ventilation specifically in postoperative exploratory laparotomy patients requiring invasive mechanical ventilatory support. We hypothesize that post-exploratory laparotomy patients in the ICU requiring mechanical ventilation with distinct and complex cardiorespiratory pathophysiology will have superior efficacy and safety in terms of ventilatory and hemodynamic profile on advance APRV mode compared to volume-targeted PRVC mode, due to the unique intrinsic characteristics of the APRV mode.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients on invasive mechanical ventilation and admitted in ICU following exploratory Laparotomy due to acute respiratory failure (ARF) for less than 24 hours
  • Age group 18-60 years
  • Stable hemodynamic parameters (Mean Arterial Pressure between 70 mm Hg and 100 mm Hg, heart rate between 60 and 100/minute, SPO2 ≥ 90%)
  • Richmond Agitation–Sedation Scale (RASS) between 0 and -2.

排除标准

  • Pregnant and morbidly obese patients (BMI>35)
  • Patient diagnosed with acute respiratory distress syndrome (ARDS) (Mild, Moderate, or Severe) according to Berlin‘s definition.
  • Patients with severe or chronic heart, lung, hepatic or renal disease
  • Patients with severe neuromuscular disorders
  • Patient on vasopressors, cardiac depressants or neuromuscular blockers
  • Patient with traumatic brain injury
  • Patients with severe multiple organ dysfunction.

结局指标

主要结局

Ventilatory parameters: Peak airway pressure (Ppeak), plateau pressure (Pplat), mean airway pressure (Pmean), compliance (C), static compliance (Cstat), airway resistance (Raw) will be recorded

时间窗: T1-2 hours after keeping the patient on A/C VCV for 2 hours (washing period). | T2-2 hours after shifting on A/C VC mode from its original mode of ventilation (corresponding to time just before switching to study ventilatory mode). | T3-4 hours after shifting on study mode (APRV or PRVC) as per group allocation. | T4-6 hours after shifting on study mode (APRV or PRVC) as per group allocation. | T5-8 hours after shifting on study mode (APRV or PRVC) as per group allocation.

次要结局

  • Hemodynamic parameters: Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), end-tidal carbondioxide (EtCO2), percentage of oxygen saturation by pulse oximetry (SpO2), ratio of oxygen saturation to fraction of inspired oxygen (SPO2/FIO2) and urine output will be recorded(T1-2 hours after keeping the patient on A/C VCV for 2 hours (washing period).)
  • Arterial Blood Gas parameters: pH, partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2), and arterial oxygen saturation percentage (SaO2)(T1-2 hours after keeping the patient on A/C VCV for 2 hours (washing period).)

研究者

申办方类型
Government medical college

研究点 (1)

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