跳至主要内容
临床试验/NCT04164173
NCT04164173招募中不适用

Hyperinflation Respiratory Therapies in Cardiac Surgery Patients: A Randomized, Observer-Blinded, Prospective Clinical Trial

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
324
试验地点
2
主要终点
Postoperative lung function as assessed by the changes in FEV1/FVC

研究概览

简要总结

The purpose of this prospective randomized clinical trial is to evaluate three different types of hyperinflation respiratory therapies, Intermittent Positive Pressure Breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), Metaneb. Investigators will examine which hyperinflation therapy provides better lung expansion and may improve lung recovery after surgery.

详细描述

Postoperative pain due to surgical incision may limit lung expansion. After cardiac surgery, all patients receive respiratory therapies, because it is critical to expand lung after surgery to prevent respiratory complications such as lung collapse (atelectasis) due to shallow breathing or accumulation of airway secretions.

Although incentive spirometer is the most common method used for lung recovery after cardiac surgery, some studies were not able to find any benefits from the use of incentive spirometer. Inspiratory positive-pressure breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), and chest airway clearance (Metaneb) are hyperinflation therapies used after surgery. The purpose of this research study is to determine which hyperinflation respiratory therapy provide better lung recovery after cardiac surgery.

Hyperinflation Respiratory Therapies:Participants will be randomly assigned one of the hyperinflation respiratory therapy, intermittent positive pressure breathing (IPPB) and the EzPAP or the Metaneb.

  1. Intermittent positive pressure breathing (IPPB) is a respiratory therapy technique which will support your breathing by providing pressure support. This respiratory method will increase air volume breathing in.
  2. The EzPAP is another respiratory treatment and participants will breath against to resistance in order to prolong the time the lung remain open.
  3. The Metaneb will provide resistance when patients breathing in order to prolong the lung opening.

Hyperinflation therapy will be performed every 4 hours in the intensive care unit (ICU). Each respiratory therapy session will take about 15 minutes. Participants' pulmonary function will be evaluated daily to monitor the lung recovery with microspirometer which will take place approximately 5 minutes. Total study duration is about 96 hours after surgery or until discharge from the Intensive Care Unit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Assessment respiratory therapist will be blinded to respiratory therapy modalities.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years and older
  • Admitted to Cardiovascular ICU (CVICU) after coronary artery bypass grafting (CABG), isolated valve repair/replacement, or CABG + valve repair/replacement
  • Cardiac surgery performed via median sternotomy

排除标准

  • Refusal to be consented
  • Prior or current lung transplant patients

结局指标

主要结局

Postoperative lung function as assessed by the changes in FEV1/FVC

时间窗: Up to 96 hours postoperatively or until discharge from the intensive care unit (ICU), whichever came first.

The postoperative changes in the Forced Expiratory Volume in one second (FEV1)/the Forced Vital Capacity (FVC) in microspirometry

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

Jaffer Odeh

Assistant Profesor

University of Texas Southwestern Medical Center

研究点 (2)

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