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临床试验/NCT05353127
NCT05353127已完成不适用

Influence of Different Data Averaging Methods on Preoperative Risk Assessment Using Cardiopulmonary Exercise Testing in Patients Scheduled for Colorectal Surgery

VieCuri Medical Centre1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
1
主要终点
Influence of different CPET data averaging intervals on the numerical values of CPET-

研究概览

简要总结

Cardiopulmonary exercise testing (CPET) is used for preoperative risk assessment in patients with colorectal cancer who need to undergo surgery. For presentation and interpretation purposes, CPET data are averaged by using a time- or breath-based average. It is uncertain to what extent differences in data averaging methods influence the numerical value of preoperative CPET-derived variables used for risk assessment. Therefore, the primary aim of this study is to investigate the influence of different CPET data averaging intervals on the numerical values of CPET-derived variables used for preoperative risk assessment in patients scheduled for elective colorectal cancer surgery. The secondary aim is to elucidate the impact of data-averaging intervals on classification of patients into a low- or high-risk category for postoperative complications based on known risk assessment thresholds.

详细描述

Surgery for colorectal cancer is associated with a high incidence of postoperative complications. Risk assessment by means of a cardiopulmonary exercise test (CPET) is an essential part of the preoperative diagnostic work-up of colorectal cancer patients. During CPET, a patient exercises against a progressively increasing work rate until volitional exhaustion, while breath-by-breath respiratory gasses are analyzed. The large number of data points that are collected by the breath-by-breath sampling rate can be a burden for data visualization, as they can be noisy. Therefore, data averaging is performed to optimize graphical data display and to aid CPET interpretation. To date, there are no studies quantifying the extent to which differences in data averaging influence the numerical value of preoperative CPET-derived variables for risk assessment based on aerobic fitness, such as the the oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT), VO2 at peak exercise (VO2peak), and the oxygen uptake efficiency slope (OUES), and of preoperative CPET-derived variables for risk assessment based on ventilatory efficiency, such as the ventilatory equivalent for carbon dioxide production at the VAT (VE/VCO2VAT) and the slope of the relationship between the minute ventilation and carbon dioxide production (VE/VCO2-slope). Therefore, the primary aim of this study is to investigate the influence of different CPET data averaging intervals on the numerical values of CPET-derived variables used for preoperative risk assessment in patients scheduled for elective colorectal cancer surgery. The secondary aim is to elucidate the impact of data-averaging intervals on the classification of patients into a low- or high-risk category for postoperative complications based on known risk assessment thresholds.

Participants Data from patients considered for colorectal cancer surgery who are ≥18 years of age, have a score ≤7 metabolic equivalents of task on the veterans-specific activity questionnaire, and therefore performed preoperative CPET as a part of a prehabilitation study will be collected. Preoperative CPET was conducted before any intervention was initiated.

Procedures Preoperative CPET data will be anonymized and patient characteristics other than anthropometric measures will be concealed. A medical physiologist and a clinical exercise physiologist will determine the CPET variables VO2VAT, VO2peak, respiratory exchange ratio at peak exercise (RERpeak), VE/VCO2VAT, VE/VCO2-slope, and the OUES in all 20 CPETs using a predefined set of guidelines Final determination of each parameter will be based on consensus between the two observers. In case of disagreement between observers, a third observer will be consulted. Determination of the aforementioned CPET variables will be repeated using each of the five different data-averaging intervals. Data averaging-intervals consists of a stationary time-based average over 10, 20, and 30 seconds, and of a rolling average over 3 and 7 breaths that were defined as follows. The stationary time-based average will be calculated by averaging the breath-by-breath data over 10, 20, or 30 seconds. A rolling average is defined as averaging a fixed number of single breath measurements (i.e., 3 and 7), then discarding the first breath and adding a new breath to obtain a new breath averaging block.

CPET interpretation will be performed using Blue Cherry software version 1.3.3.3 (Geratherm Respiratory GmbH, Bad Kissingen, Germany).

Apart from the CPET data, the preoperative patient characteristics age, sex, body mass index, smoking status (never, former, current), age-adjusted Charlson comorbidity index, comorbidities, American Society of Anesthesiologists classification, veterans-specific activity questionnaire score, hemoglobin levels (mmol/L), and tumor location will be recorded.

研究设计

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

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

  • Patiënts with colorectal cancer, considered for surgery.
  • A score of ≤7 metabolic equivalents of task on the veterans-specific activity questionnaire and therefore performed preoperative CPET as a part of a prehabilitation study

排除标准

  • Patiënt unable to perform CPET.

结局指标

主要结局

Influence of different CPET data averaging intervals on the numerical values of CPET-

时间窗: Baseline, pre surgery

To assess the influence of different CPET data averaging intervals on the numerical the numerical values of the OUES.

Influence of different CPET data averaging intervals on the numerical values of CPET-derived variables.

时间窗: Baseline, pre surgery

To assess the influence of different CPET data averaging intervals on the numerical the numerical values of VO2VAT,

次要结局

  • High- or Low-risk for postoperative complications(Baseline, pre surgery)

研究者

发起方
VieCuri Medical Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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