跳至主要内容
临床试验/NCT04482556
NCT04482556招募中不适用

Comparison of the Q-NRG+ Indirect Calorimetry Device Versus the V(Max) Encore Device in Mechanically Ventilated Children

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Calculated total testing time, including calibration, required to complete a steady state indirect calorimetry measurement using the Q-NRG+ device and the V(max) Encore.

研究概览

简要总结

The overarching aim of this proposal is to examine the feasibility of the Q-NRG+ indirect calorimetry device and its agreement with (Vmax) Encore indirect calorimetry device in mechanically ventilated children. The overall hypothesis of this study is that the Q-NRG+ will provide minute-to-minute oxygen consumption (VO2) and carbon dioxide production (CO2) measurements that are in agreement with those obtained by the standard indirect calorimetry device currently used at our institution (Vmax Encore).

详细描述

Indirect calorimetry allows accurate measurement of energy expenditure in this population but current technology is cumbersome and time-consuming, and has many limitations that exclude a majority of criticaly ill children. A new device was recently developed to address some of the limitations of IC devices and is widely endorsed for IC measurements in critically ill adults. The Q-NRG+ IC device incorporates an easier gas calibration technique to facilitate faster start up, and a micro-mixing chamber (2ml) allows rapid achievement of steady state gas exchange measurement. The device may address some of the current barriers for the use of indirect calorimetry in critically ill children. A device with short calibration time and reliable measurements could enhance the ability of clinicians to deliver individualized energy prescriptions for patients.

Description of Study Treatments

Following informed consent, the following steps will be followed for the study procedure:

  1. The two testing indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient, therefore it will be decided the V(max) will be tested first in the first enrolled patient then the Q-NRG+ second. Each enrolled patient subsequently will alternate in which device is tested first.
  2. The first device will be connected to the patient, after calibration, and data collection will begin for a maximum duration of 30 minutes.
  3. At the end of the first testing period, the first device will be disconnected and the second device will be connected to the study patient.
  4. Data collection for the second device will then begin for a maximum duration of 30 minutes.
  5. At the end of the testing period, the data collected for the V(max) device will be discussed with the parents and the clinical team. Data collected from the Q-NRG+ will not be shared with the clinical team or family as this device is still being investigated in the pediatric population.
  6. The study will then conclude.

Definitions of Outcomes/Endpoints The primary variables to be collected are steady state measurements of VO2 and VCO2 from both indirect calorimetry devices. Steady state will be defined as a period of greater than five minutes with coefficient of variation of the VO2 and VCO2 measurements of less than 10%. If steady state is not achieved, energy calculations will not be included in data analysis. Secondary variables to be collected include total time to obtain indirect calorimetry measurement, from arrival at the bedside to completion of the study. Steady state conditions will be defined using existing institutional practice.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Children mechanically ventilated with endotracheal tube of tracheostomy in standard ventilatory modes such as SIMV-PC, SIMV-VC or PRVC
  • •Age > 10 years AND weight > 10kg
  • •FIO2 < 60%
  • •PEEP < 8
  • •ETT leak < 10%
  • •The attending physician of record plans to order indirect calorimetry and considers research activity safe

排除标准

  • •Hemodynamic instability (hypotension according to PALS/ACLS formula or requiring 2 or greater vasoactive infusions)
  • •Presence of chest tubes with ongoing air leak
  • •Patients requiring ECMO support
  • •Patients undergoing end-of-life care
  • •Primary provider declines enrollment.

研究组 & 干预措施

Q-NRG+ Indirect Calorimetry Device

Other

Q-NRG+ device will be compared to current V(max) device in each enrolled patient in subsequent, alternating fashion.

干预措施: Q-NRG+ Indirect Calorimetry Device (Device)

V(max) Encore Indirect Calorimetry Device

Other

V(max) Encore device, currently institution's standard device, will be compared to Q-NRG+ device in each enrolled patient in subsequent, alternating fashion.

干预措施: V(max) Encore Indirect Calorimetry Device (Device)

结局指标

主要结局

Calculated total testing time, including calibration, required to complete a steady state indirect calorimetry measurement using the Q-NRG+ device and the V(max) Encore.

时间窗: 1 hour/participant

Total time lapsed, including time for patient data input, warm-up, calibration, and gas exchange measurements in steady state will be recorded. Our hypothesis is that the time required to obtain energy expenditure with Q-NRG+ device will be significantly shorter as compared to the Vmax Encore device.

Mean bias and limits of agreement between measured oxygen consumption (VO2) and carbon dioxide elimination (VCO2) in mechanically ventilated children assessed using the Q-NRG+ indirect calorimetry device and the V(max) Encore indirect calorimetry device.

时间窗: 1 hour/participant

In mechanically ventilated children, we will describe the mean bias and limits of agreement in measurements using both indirect calorimeters. Our hypothesis is that the measurement of oxygen consumption (VO2) and carbon dioxide production (VCO2) with the 2 devices will have a low mean bias and will be within clinically acceptable limits of agreement.

次要结局

未报告次要终点

研究者

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

Ben D. Albert, MD

Director, Critical Care Medicine Fellowship Program

Boston Children's Hospital

研究点 (1)

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