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临床试验/NCT06132100
NCT06132100尚未招募不适用

Using Wireless Transformation of Portable Three-ball Incentive Spirometers to Assist the Record of Postoperative Rehabilitation and Pulmonary Function Change in Patients Undergoing Abdominal Surgery

Taipei Medical University Shuang Ho Hospital0 个研究点目标入组 200 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
主要终点
Apnea/Hyponea Index

研究概览

简要总结

The purpose of this clinical trial is to use a digital recording device integrated with an incentive spirometer to record a patient's deep breathing lung training following abdominal surgery. Through this digital recording, it will be possible to effectively assess the daily frequency, duration, depth of deep breaths, and the volume of inhalation performed by the patient during their breathing exercises. This will transform the previously difficult-to-describe deep breathing training into a digital record, allowing healthcare professionals to quickly evaluate the patient's condition. Patients can also monitor their own respiratory function changes, leading to positive health promotion benefits, accelerating their postoperative recovery, and simultaneously reducing healthcare costs and improving medical quality.

详细描述

After thoracoabdominal and neurosurgery procedures, an incentive spirometer is commonly employed for deep breathing exercises to prevent or improve potential postoperative pulmonary atelectasis, increase lung capacity, promote the clearance of respiratory secretions, and maintain chest mobility to reduce postoperative complications related to lung collapse. This medical device and the respiratory training process are essential components of Enhanced Recovery After Surgery (ERAS) protocols, which integrate postoperative care processes to enhance recovery, reduce hospitalization times, and minimize postoperative complications. Currently, clinical guidelines typically recommend patients to perform 200-600 deep inhalations per day after surgery. Despite the simplicity and effectiveness of using an incentive spirometer for deep breathing exercises, the observation of patients' usage, recording of the number and duration of exercises, and tracking of their deep inhalation volumes have become crucial tasks for respiratory therapists, nurses, and physicians in the postoperative setting, consuming significant time and resources.

Generally, using an incentive spirometer requires patients to perform 200-600 deep breaths a day. According to a 2018 medical literature estimate in the United States, approximately 9.7 million surgical procedures annually involve the use of incentive spirometers, with human resource costs for assisting patients in their use and assessing the effectiveness of their pulmonary rehabilitation reaching approximately one billion US dollars.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Investigator and outcomes assessor did not know the allocation of participant.

入排标准

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

入选标准

  • •Patients undergoing bariatric surgery
  • •Patients could cooperate with conducting incentive spirometry before and after the operation.

排除标准

  • •Patients with contra-indication for incentive spirometry.
  • •Patients could not deeply breathe with pulmonary vital capacity less than 10mL/kg.
  • •Patients could not cooperate with conducting incentive spirometry before and after the operation.
  • •Other causes judged by the Principal Investigator

研究组 & 干预措施

digitalized incentive spirometry

Experimental

patients with digitalized incentive spirometry

干预措施: digitalized incentive spirometry (Device)

traditional incentive spirometry

Placebo Comparator

patients with traditional incentive spirometry

干预措施: traditional incentive spirometry (Device)

结局指标

主要结局

Apnea/Hyponea Index

时间窗: 7 - 10 days

Post operative

Pulse oximetry change

时间窗: 7 - 10 days

Post operative

次要结局

  • Postoperative pulmonary complication(7-10 days)

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ShihChiang Shen

Visiting staff

Taipei Medical University Shuang Ho Hospital

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