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临床试验/NCT06307379
NCT06307379招募中不适用

Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures

Vitaz1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Vitaz
入组人数
300
试验地点
1
主要终点
Procedure-related pain scale (VAS)

研究概览

简要总结

'Patient-reported outcomes' (PROMS) and 'patient-reported experiences' (PREMS) are increasingly important parameters in evaluating and adjusting clinical procedures and strategies in healthcare.

Validated disease-specific PROMS related to bronchoscopic procedures are not available and examples in the medical literature are very scarce.

详细描述

The potential usefulness of PROM/PREMS is multiple:

  1. Quality improvement within the current clinical care structure
  2. Monitoring the health status of the population
  3. Contribution to decision-making regarding financing of care
  4. Increase employee and patient involvement in clinical care pathways
  5. Rationalize the deployment of medical personnel and resources
  6. Integration of data in electronic patient files and registers

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

  • Age above 18 years
  • Patient referred for diagnostic flexible bronchoscopy
  • Procedure performed in outpatient setting

排除标准

  • Patient unable to adequately respond to the contents of the patient questionnaire.
  • Procedure performed in hospitalised setting
  • Patient with active pregnancy

结局指标

主要结局

Procedure-related pain scale (VAS)

时间窗: 24 hours

Procedure-related pain scale (VAS)

Procedure-related dyspnea scale (VAS)

时间窗: 24 hours

Procedure-related dyspnea scale (VAS)

Procedure related cough scale (VAS)

时间窗: 24 hours

Procedure related cough scale (VAS)

General patient satisfaction

时间窗: 24 hours

General patient satisfaction VAS scale

次要结局

  • Sedation-related complications(24 hours)
  • Procedure-related complications:(24 hours)
  • Diagnostic yield(30 days)

研究者

发起方
Vitaz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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