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临床试验/NCT04887415
NCT04887415已完成不适用

Safety, Feasibility, and Impact of Preoperative Respiratory Strength Training in Cardiac Surgical Patients

University of Florida2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Adherence to Respiratory Strength Training

研究概览

简要总结

Swallowing difficulty (dysphagia) is a common postoperative complication in patients who undergo cardiac surgical procedures. Postoperative dysphagia in cardiac surgical patients is associated with negative health-related outcomes including increased rates of pneumonia, reintubation, and death as well as increased length of hospital stay and costs of care. This study will examine the safety, feasibility, and impact of preoperative respiratory strength training (RST) on swallowing and associated health-related outcomes in cardiac surgical patients. We hypothesize that preoperative RST will be safe, well-tolerated, and lead to improved swallowing and health-related outcomes in cardiac surgical patients.

详细描述

Enrolled research participants will undergo baseline assessments of pulmonary function: maximum expiratory pressure (MEP), maximum inspiratory pressure (MIP), cough function (voluntary PEF and cough spirometry), and will complete self-reported dyspnea using the validated London Chest Activity of Daily Living (LCADL) scale. Following baseline testing, participants will complete a respiratory strength training program (RST) in the home via telehealth with one in-person home therapy session conducted at each participant's midpoint to reassess MEP and MIP and to recalibrate the respiratory strength trainer devices. After the prescribed RST program, participants will complete a second post-RST preoperative assessment. All pulmonary function measures will be performed by a research SLP in accordance with standardized protocols and guidelines from the American Thoracic Society 12-14 with research participants in an upright seated position with nose clips in place. A swallowing examination (FEES) will be completed both pre and post surgery to assess any impact on swallowing safety.

Respiratory Assessment:

MEP and MIP measurements will be obtained using a MicroRPM handheld menometry device (MicroDirect). For MEP testing, research participants will be instructed to take a deep breath in, place their mouth around the mouthpiece, and blow out as forcefully as possible. As needed, the research SLP will assist with lip seal by holding the sides of participant's cheeks to prevent air leakage. For MIP testing, research participants will be instructed to expel all the air out of their lungs, place their mouth around the mouthpiece, and breathe in as forcefully as possible. Each participant will perform 3 MEP and MIP trials. Average MEP and MIP values will be used to calibrate expiratory and inspiratory devices and for subsequent analyses.

Respiratory Strength Training (RST) Program:

The RST program consists of expiratory muscle strength training (EMST) and inspiratory muscle strength training (IMST) using the EMST-75 Lite or the EMST-150 and the IA-150 devices (Aspire Products), respectively. Trainer devices will be calibrated to a 50% load of individualized MEP and MIP values. The CS patients will perform 25 repetitions each (5 sets of 5 repetitions) of the expiratory and inspiratory exercises, 5 days/week leading up to their surgical procedure. The patients will be given training logs to track completion of the RST exercises to measure adherence.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult 18-90 years old.
  • Not pregnant.
  • Undergoing planned cardiac surgery via sternotomy &/or extended thoracotomy & seen in the UF Health preoperative clinic.
  • Confirmed COVID-19 negative test and/or no recent COVID-19 symptoms
  • Has access to a computer, tablet, or electronic device with a stable internet connection for telehealth sessions.
  • Willing to undergo testing procedures and complete the exercise training program

排除标准

  • Individuals under the age of 18 or over the age of
  • Pregnant women.
  • Positive for COVID-19 or symptoms of COVID-19
  • No access to a computer, tablet, or electronic device &/ a stable internet connection for telehealth sessions.
  • Unwilling to undergo testing procedures and/or complete the exercise training program.

结局指标

主要结局

Adherence to Respiratory Strength Training

时间窗: 4 weeks

Number of respiratory strength training repetitions

Change in Maximum Expiratory Pressure (MEP) Between Pre and Post Respiratory Strength Training

时间窗: 4 weeks

A measure of maximum expiratory respiratory strength (in cmH2O) prior to and after completing RST program.

Change in Cough Peak Expiratory Flow Between Pre and Post Respiratory Strength Training

时间窗: 4 weeks

A measure of cough strength (in L/min of air flow) prior to and after completing RST program.

Attendance at Telehealth Sessions

时间窗: 4 weeks

Number of Telehealth sessions completed

Change in Maximum Inspiratory Pressure (MIP) Pre and Post Respiratory Strength Training

时间窗: 4 weeks

A measure of maximum inspiratory strength (in cmH2O) prior to and after completing RST program.

Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).

时间窗: 5 weeks

The Penetration-Aspiration Scale (PAS) is a validated 8-point ordinal rating scale that measures the depth of airway invasion of bolus material and patient response during swallowing. PAS scores range from 1 to 8, with a score of 1 indicating a safe swallow (no penetration or aspiration of bolus material) (best score) and 8 indicating silent aspiration (bolus material reached below the level of the vocal folds and no response / effort to eject material was made) (worst score). After analysis of the FEES examination, the worst overall PAS score across was determined across all bolus types administered during the exam and recorded for both the preoperative FEES exam and the post-operative FEES exam.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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