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临床试验/NCT05193266
NCT05193266已完成不适用

Gastroesophageal Reflux Disease and Its Health-related Quality of Life Among ICU Survivors

Sanjay Gandhi Postgraduate Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2022年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
116
试验地点
1
主要终点
Prevalence of Gatroesophageal reflux disease (GERD) among ICU survivors

研究概览

简要总结

Gastro-esophageal reflux disease (GERD) is a condition characterized by reflux of stomach contents causing troublesome symptoms and complications. Typical symptoms include heart burn (a retrosternal burning sensation), regurgitation (perception of flow of refluxed stomach content into the mouth or hypopharynx) and chest pain. As per recently published global guidelines (2017) by World Gastroenterology Organisation (WGO), the presence of heartburn and/or regurgitation symptoms 2 or more times a week is suggestive of GERD. Global burden of GERD in general population is approximately 1.03 billion, the prevalence of GERD varies geographically, with the highest prevalence of 19.55% in North America while in Asia, the estimated rate is 12.92%. However the data regarding the prevalence of GERD in intensive care unit (ICU) population is not yet established; which is expected higher after recovery from their current acute illness. In a healthy individual, several factors contribute to the prevention of reflux and to minimizing esophageal acid exposure: lower esophageal sphincter (LES) pressure, the diaphragmatic crura, gravity, esophageal peristalsis, salivary bicarbonate and the integrity of esophageal epithelium. But in critically ill these factors are compromised leading to high incidence of GERD. Interventions commonly used in managing critically ill patients such as sedation, presence of an endotracheal tube, mechanical ventilation, enteral tube feedings, positioning, and medications, along with specific patient characteristics and comorbid conditions contribute to an increased risk for GERD in this population. GERD results in various symptoms which has impact on quality of life. Various reliable and validated generic and disease specific instruments are available to measure symptom severity of the disease. In the present study, among GERD patients, commonly and freely available GERD-Health-related quality of life (GERD-HRQL) score will be used which is a disease-specific instrument. This observational study will screen and enroll adult patients who survived at the time of ICU discharge.

详细描述

During study period, all patients who survived at the time of ICU discharge will be considered as per inclusion and exclusion criteria. All eligible participants will be screened for the presence of GERD. If GERD present, participants will be followed for their symptoms after 6 week of the ICU discharge. Participant who did not having GERD at the time of ICU discharge will also be followed for the presence of GERD symptoms at 6 weeks after ICU discharge, if participant develop GERD symptoms then they will be followed up again for next 6 weeks. In participants who had GERD symptoms, HRQL score will be collected including 6-week follow up, after obtaining the informed written consent.

Demographic and clinical characteristics of all eligible participants will be collected on structured proforma. ICU prognostication scores, i.e., Acute Physiologic and Chronic Health Evaluation (APACHE) II score and Sequential Organ Dysfunction Assessment (SOFA) will be noted. All relevant and possible risk factors during ICU stay will also be collected. Participants with GERD, GERD-HRQL score will be collected, including 6-week follow-up.

At the time of ICU discharge, participant will be asked for the preference for the way of communication during follow-up with the option of pre-stamped envelope for postal with questionnaire. Participants will be handed over these envelopes with mention of pre-defined follow-up date for that particular patient. In case participant has plan for SGPGIMS visit for his/her pre-scheduled follow-up with any specialty, then data for present study will be collected in person.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (>18 years) who survived at the time of ICU discharge

排除标准

  • ICU stay <96 hours
  • At the time of ICU discharge GCS <15
  • Presence of open abdomen (post surgery)
  • Presence of feeding tube at the time of ICU discharge
  • Presence of abdominal drain or PEG tube at the time of ICU discharge
  • Presence of tracheostomy tube at the time of ICU discharge
  • Patient who do not provide written consent
  • Pregnancy

结局指标

主要结局

Prevalence of Gatroesophageal reflux disease (GERD) among ICU survivors

时间窗: 12 weeks after ICU discharge

Percentage of ICU survivors among whom Gatroesophageal reflux disease (GERD) present

次要结局

  • Gatroesophageal reflux disease-Health-related quality of life score among GERD present patients(12 weeks after ICU discharge)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohan Gurjar

Professor, Critical Care Medicine

Sanjay Gandhi Postgraduate Institute of Medical Sciences

研究点 (1)

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