Prevalence of Right Ventricular dysfunction subphenotypes and their utility as predictor of outcomes in patients of ARFA (At risk for ARDS) on invasive mechanical ventilation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Demographic , biochemical and Echo/USG data will be collected within 72 hours of admission which is part of standard of care.
研究概览
简要总结
Prevalence of Right Ventricular dysfunction subphenotypes and their utility as a predictor of outcomes in patients of ARFA (At risk for ARDS) on invasive mechanical ventilation AIM - To identify RV dysfunction subphenotypes and to use it as a predictor of outcome in patients of ARFA on IMV OBJECTIVES- 1.To identify prevalence of the sub-phenotypes of RV dysfunction based on trans thoracic echocardiography namely : a)RV dilation with preserved function – RV LVEDA ratio more than 0.6, RV basal diameter more than equal to 41 mm and TAPSE more than equal to 18 mm, b)RV dilation with impaired function – RV LVEDA ratio more than 0.6 ,RV basal diameter more than equal to 41 mm and TAPSE less than 18 mm 2.Utility of categorising RV dysfunction sub-phenotypes as a predictor of outcome ,namely 28 day mortality, days of ICU stay, days of hospital stay. 3.Assessing the fluid status in the different phenotypes based on IVC diameter and cumulative 48 hours intake output charts in the ICU HYPOTHESIS- The prevalence of Subphenotype 2 of RV dysfunction in patients with ARFA is similar to patients with ARDS (13 percent) Justification for study - Why ARFA? Burden of illness- Recently, incidence ranges for acute respiratory failure , acute respiratory distress syndrome (ARDS) in adults were reported and found to be 77.6–88.6 and 12.6–28.0 cases out of 100 000 population per year, respectively. Mortality rates of approximately 40 per cent were reported for patients with acute respiratory failure, and similar or slightly lower rates for those with ARDS. Why the need for identifying the different RV subphenotypes ? In patients with compensated RV dilation - reducing the RV afterload and venous congestion is necessary to mitigate progression to decompensated RV failure. However in patients where RV systolic function and cardiac output are compromised , the afore mentioned therapies would be inadequate , rather trials of inotrope/inodilator therapies or mechanical circulatory support would be required. Hence identifying the different RV subphenotypes aids in better patient care and management Departments involved: Medicine department , Critical Care Medicine department , Kasturba Hospital, Manipal Study period: Post IEC approval to April 2027 Sample size: Based on the prevalence of sub-phenotype 2 ( RV dilated with impaired RV function) in ARDS being 13per cent , and expecting the same to be in patients with ARFA, the prevalence formula was used for the calculation of the sample size) N is 174 patients of ARFA on IMV INCLUSION CRITERIA : Patients more than 18 years on invasive mechanical ventilation admitted in Kasturba hospital Patients in ARFA (i.e., not entirely fulfilling the diagnostic criteria of ARDS) Presence of any of the following radiological features(C-X-ray, Lung ultrasound,CT) 1.Alveolar infiltrates (can be hemorrhagic) 2.Interstitial infiltrates 3. Atelectasis 4.Consolidation 5.Ground glass opacities 6.Air bronchogram in lung ultrasound Respiratory Symptoms (at least one) New or increased cough New or increased sputum production Dyspnea Pleuritic chest pain Other Signs or Findings (at least one) Abnormal lung sounds (rhonchi or rales) Fever (more than equal to 100.4 F) Leukocytosis or unexplained bandemia (above normal limits for laboratory) Hypoxia (less than 90per cent) EXCLUSION CRITERIA 1)ARFA patients on NIV 2)Patients not recruited within first 24 hours of IMV 3)Patients already having pre-existing Pulmonary Artery Hypertension 4)Patients having pre-existing EF of less than 40 per cent 5)Patients on any biological agent, prednisone equivalent of more than 10 mg/day and 700 mg cumulative dose , antiproliferative agents and B ,Tcell depletion medications 6)Patients having malignancies -Patient will be selected based on the above mentioned inclusion/exclusion criteria and are recruited into the study after taking informed consent -Demographic , biochemical and Echo/USG data will be collected within 72 hours of admission which is part of standard of care.Hence the investigator will only collect the reports. - Outcome will assessed based on duration of Icu stay, use of vasopressors and mechanical ventilation. - Outcomes will be analyzed at the time of discharge – Improved/Expired - Outcome measures: Outcome will assessed based on duration of Icu stay, use of vasopressors and mechanical ventilation.
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 more than 18 years on invasive mechanical ventilation admitted in Kasturba hospital Patients in ARFA (i.e., not entirely fulfilling the diagnostic criteria of ARDS) Presence of any of the following radiological features(C-X-ray, Lung ultrasound,CT) 1.Alveolar infiltrates (can be hemorrhagic) 2.Interstitial infiltrates
- •Atelectasis 4.Consolidation 5.Ground glass opacities 6.Air bronchogram in lung ultrasound Respiratory Symptoms (at least one) New or increased cough New or increased sputum production Dyspnea Pleuritic chest pain Other Signs or Findings (at least one) Abnormal lung sounds (rhonchi or rales) Fever (more than or equal to 100.4 °F) Leukocytosis or unexplained bandemia (above normal limits for laboratory) Hypoxia (less than 90%).
排除标准
- •ARFA patients on NIV 2)Patients not recruited within first 24 hours of IMV 3)Patients already having pre-existing Pulmonary Artery Hypertension 4)Patients having pre-existing EF of less than 40 per cent 5)Patients on any biological agent, prednisone equivalent of more than 10 mg per day and 700 mg cumulative dose , antiproliferative agents and B or T cell depletion medications 6)Patients having malignancies.
结局指标
主要结局
Demographic , biochemical and Echo/USG data will be collected within 72 hours of admission which is part of standard of care.
时间窗: 24 HOURS , 72 HOURS
Hence the investigator will only collect the reports.
时间窗: 24 HOURS , 72 HOURS
Outcome will assessed based on duration of Icu stay, use of vasopressors and mechanical
时间窗: 24 HOURS , 72 HOURS
ventilation.
时间窗: 24 HOURS , 72 HOURS
Outcomes will be analyzed at the time of discharge – Improved/Expired
时间窗: 24 HOURS , 72 HOURS
次要结局
未报告次要终点
研究者
JERUSHA ANN MATHEWS
KASTURBA MEDICAL COLLEGE , MANIPAL
