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随机对照试验评估新型通讯设备在无创通气治疗中的应用。

Randomized Controlled Trial of a Novel Communication Device Assessed During Noninvasive Ventilation Therapy.

机构信息

Emory University Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine; Emory University Department of Medicine.

Emory University Department of Medicine.

出版信息

Chest. 2021 Apr;159(4):1531-1539. doi: 10.1016/j.chest.2020.09.250. Epub 2020 Oct 1.

DOI:10.1016/j.chest.2020.09.250
PMID:33011202
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8039010/
Abstract

BACKGROUND

Noninvasive ventilation (NIV), a form of positive airway pressure (PAP) therapy, is the standard of care for various forms of acute respiratory failure (ARF). Communication impairment is a side effect of NIV, impedes patient care, contributes to distress and intolerance, and potentially increases intubation rates. This study aimed to evaluate communication impairment during CPAP therapy and demonstrate communication device improvement with a standardized protocol.

RESEARCH QUESTION

How does an oronasal mask affect communication intelligibility? How does use of an NIV communication device change this communication intelligibility?

STUDY DESIGN AND METHODS

A single-center randomized controlled trial (36 outpatients with OSA on CPAP therapy) assessed exposure to CPAP 10 cm HO and PAP communication devices (SPEAX, Ataia Medical). Communication impairment was evaluated by reading selected words and sentences for partners to record and were tabulated as %words correct. Each outpatient-partner pair performed three assessments: (1) baseline (conversing normally), (2) mask baseline (conversing with PAP), and (3) randomized to functioning device (conversing with PAP and device) or sham device. After each stage, both outpatients and partners completed Likert surveys regarding perceived intelligibility and comfort.

RESULTS

While conversing with PAP, word and sentence intelligibility decreased relatively by 52% (87% vs 41%) and relatively by 57% (94% vs 40%), respectively, compared with normal conversation. Word and sentence intelligibility in the intervention arm increased relatively by 75% (35% vs 61%; P < .001) and by 126% (33% vs 76%; P < .001) higher than the control arm, respectively. The device improved outpatient-perceived PAP comfort relatively by 233% (15% vs 50%, P = .042) and partner-perceived comfort by relatively 245% (20% vs 69%, P = .0074).

INTERPRETATION

Use of this PAP communication device significantly improves both intelligibility and comfort. This is one of the first studies quantifying communication impairment during PAP delivery.

TRIAL REGISTRY

ClinicalTrials.gov; No.: NCT03795753; URL: www.clinicaltrials.gov.

摘要

背景

无创通气(NIV)是一种正压通气(PAP)疗法,是各种形式急性呼吸衰竭(ARF)的标准治疗方法。沟通障碍是 NIV 的一种副作用,会妨碍患者护理,导致痛苦和不耐受,并可能增加插管率。本研究旨在评估 CPAP 治疗期间的沟通障碍,并展示使用标准化方案改善 NIV 沟通设备的效果。

研究问题

口鼻面罩如何影响沟通清晰度?使用 NIV 沟通设备如何改变这种沟通清晰度?

研究设计和方法

一项单中心随机对照试验(36 名接受 CPAP 治疗的 OSA 门诊患者)评估了 CPAP 10cmH2O 暴露和 PAP 沟通设备(SPEAX、Ataia Medical)的影响。通过让伴侣记录阅读选定单词和句子来评估沟通障碍,并以正确单词的百分比进行列表。每对门诊患者和伴侣进行三次评估:(1)基线(正常对话),(2)面罩基线(用 PAP 对话),(3)随机使用功能设备(用 PAP 和设备对话)或假设备。每个阶段后,门诊患者和伴侣都完成了关于感知清晰度和舒适度的李克特量表调查。

结果

与正常对话相比,使用 PAP 时,单词和句子的清晰度分别相对下降了 52%(87%对 41%)和相对下降了 57%(94%对 40%)。干预组的单词和句子清晰度相对增加了 75%(35%对 61%;P<0.001)和 126%(33%对 76%;P<0.001)。该设备相对提高了门诊患者感知的 PAP 舒适度 233%(15%对 50%,P=0.042),提高了伴侣感知的舒适度 245%(20%对 69%,P=0.0074)。

解释

使用这种 PAP 沟通设备显著提高了清晰度和舒适度。这是量化 PAP 输送过程中沟通障碍的首批研究之一。

试验注册

ClinicalTrials.gov;编号:NCT03795753;网址:www.clinicaltrials.gov。

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