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临床试验/NCT03008174
NCT03008174已完成不适用

Early Speech With One-Way Speaking Valve in Tracheostomy Patients - Pilot Study

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Speech Intelligibility as Assessed by Speech Intelligibility Test Score

研究概览

简要总结

Patients with tracheostomy who are on and off of mechanical ventilation initially lose the ability to speak, and the use of one-way speaking valves (OWSV) is one method of restoring speech in these patients. Patients with tracheostomy who experience loss of speech report frustration and feelings of confinement from patients' communication impairment, therefore investigators would like to restore speech in these patients as soon as it is safe to do so. However, there is currently little known in the literature about the timing of the use of OWSV in patients with tracheostomy. Therefore, the investigators propose a pre-test post-test clinical trial pilot study to investigate the safety of early use of OWSV in patients undergoing a percutaneous tracheostomy. Study aims are to identify patients who would benefit from the early use of OWSV and to determine the effects of early use of OWSV on speech and clinical outcomes. To achieve these aims, patients who undergo percutaneous tracheostomy will be screened, and patients meeting screening criteria will be randomized into intervention and control groups. The intervention group will receive early speech-language pathology (SLP) evaluation and OWSV trial at 12-24 hours following tracheostomy procedure, and the control group will receive standard SLP evaluation and OWSV trial at 48-60 hours following tracheostomy procedure. Intervention and control groups will been compared on speech and clinical outcomes measures from pre-test at 12-24 hours following tracheostomy and post-test at 48-60 hours following tracheostomy and characteristics of patients who successfully tolerate early OWSV use will be identified.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Patient who received a percutaneous tracheostomy
  • •Glasgow Coma Scale score ≥9
  • •Confusion Assessment Method -ICU (CAM-ICU): negative
  • •Richmond Agitation Sedation Scale (RASS): -1 to +1
  • •Able to understand English

排除标准

  • •Open tracheostomy
  • •Laryngectomy
  • •Presently using OWSV or capped trach
  • •Foam-filled cuffed tracheostomy tube
  • •Presence of known severe airway obstruction
  • •Presence of post-operative bleeding requiring transfusion or packing
  • •Presence of air-leak around the cuff resulting in respiratory decompensation

研究组 & 干预措施

Intervention

Experimental
  1. Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.
  2. Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.
  3. Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.

干预措施: Early one-way speaking valve (OWSV) assessment (Other)

Control

No Intervention
  1. Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.
  2. Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.

结局指标

主要结局

Speech Intelligibility as Assessed by Speech Intelligibility Test Score

时间窗: Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Speech Intelligibility as Assessed by Speech Intelligibility Test Score

时间窗: Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Speech Intelligibility as Assessed by Speech Intelligibility Test Score

时间窗: Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

次要结局

  • Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores(Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period))
  • Number of Participants With Bleeding(At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure)
  • Intensive Care Unit (ICU) Length of Stay(At the time of discharge, up to 4 months)
  • Hospital Length of Stay(At the time of discharge, up to 4 months)
  • Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores(Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period))
  • Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores(Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period))
  • Number of Participants With Bleeding(At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure)
  • Number of Participants With Bleeding(At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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