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临床试验/NCT02809807
NCT02809807已完成不适用

The Impact of the Work of Breathing and Gas Exchange for COPD Patient Using a Gas Mask.

Laval University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Indexes of respiratory effort

研究概览

简要总结

Background: The gas mask is used to protect the aiways against respiratory hazards (CBRN agents). Within the CBRNE committee, speculations are that unprotected lungs would look like to those of COPD patients in post-exposure of some CBRNE agents. The aim of the study was to evaluate the impact of the gas mask on respiratory patterns and indexes of the respiratory effort. Methods: We are completing our study with 9 COPD patients to evaluate breathing patterns, index of respiratory efforts and blood gases. Three conditions have been tested in a randomized order: 1x baseline and 2x different canisters, with and without a mask (C4, Airboss Defence, Bromont, Canada). Airway pressure, inspiratory and expiratory flows have been measured. An esophageal catheter is introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 is continuously measured and capillary blood bases are drawn at the end of each condition. Each condition lasts 10 minutes, data of the last 2 minutes at a steady state are considered for analyses. Results. We are compiling data and processing them for analysis.

详细描述

The principal way of penetration of CBRNE agents is the respiratory system. The current technology of a gas mask has been used to protect the respiratory system as far back as the First World War. That originated from Dr Cluny Macpherson's initiatives whom was a Canadian military physician.

The military gas mask is part of the respirator classification but owes its specific features. Conventionally, the military gas mask covers a large spectrum of protection aspects and matched with their specific canisters. Consequently, gas masks are usually studied separately from other respirators and Self-Contained Breathing Apparatus (SBCA). While few studies have been about the gas mask technology, no-study addresses it in regards of the impact from a bad airway protection and consequences on the respiratory system.

The gas mask design and its components may lead to these respiratory load issues. At rest and from different resistances, what would be the impacts for the work of breathing and gas exchange? In order to avoid hypoxemia and hyperoxia, what would be the optimal means to restore proper oxygenation? We hypothesised on a: i. Heightened WOB and the respiratory demands related to wear of the gas mask; ii. An occurrence of hypoxemia will be manifesting during a continuous period. Our goal is to measure the impact of the work of breathing and the gas exchange for a gas mask user and also a COPD patient. We also measure what was the optimal means for correcting the hypoxemia with a subject.

9 COPD patients have been participating in a comparison and single-blind randomized experimental study. That was approved by the Ethical Review Committee. A written consent is obtained for all the subjects prior their acceptance. No rejection has happened during the recruiting so far. The eligibility criteria are: i. COPD diagnosis from mild-to-severe FEV 30-80%). The exclusion criteria are: i. Refusals relate to wear the oesophageal catheter and for capillary punctures; ii. Claustrophobia; iii. Oesophageal wounds backgrounds; iv. No coronary background and stroke history; v. No face morphology incompatibility with the mask. Spirometry and usual health screening is also done before starting the clinical trial.

Design comprises three 10-minute testing conditions split in two parts. All has been at rest and sitting on a chair: i. Baseline without gas mask; ii. Gas mask and Canister A; iii. Gas Mask and Canister B. Between the condition a 5-minute wash-out takes place.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD Diagnosis: mild-to-moderate, with FEV1 30-80% and requiring no long-term oxygenotherapy.

排除标准

  • Refuse to participate in the study for one of the following reasons: i. wearing a oesophageal catheter; ii. wearing the gas mask; iii. giving blood sample; iv. claustrophobia.
  • Oesophageal background wounds
  • Facial anthropometrical issues.

结局指标

主要结局

Indexes of respiratory effort

时间窗: 10 minutes

At rest

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

François Lellouche

Research Director

Laval University

研究点 (2)

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