跳至主要内容
临床试验/NCT06460584
NCT06460584招募中不适用

Effect of Incentive Spirometer and Pursed Lip Breathing to Improve Dyspnea, Oxygen Saturation and Hospital Stay After Whipple Procedure.

Riphah International University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1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
60
试验地点
2
主要终点
Pulse Oximeter

研究概览

简要总结

Whipple procedure is one of the most complex surgeries among hepatobiliary surgeries. It has named as Pancreaticoduodenectomy. It can cause many PPCs. Lung volumes are reduced due to atelectasis and pneumonia. Incentive spirometer (IS) is used to prevent PPCs. Due to general anesthesia, atelectasis is among most frequent PPCs. Pursed Lip Breathing (PLB) supports the patient to control the breath. The shriveling lips provide resistance to the air flowing out of the lungs. Airway collapse can be prevented by prolonged exhalation. Dyspnea occurs during 6MWT when patient performs walk in corridor. The aim of this study is to check the effect of Incentive Spirometer and Pursed Lip Breathing to improve dyspnea, oxygen saturation and hospital stay after Whipple procedure. This research of RCT will check the effect of IS and PLB by taking sample size of 60 post-operative patients through convenient sampling technique by allocating them randomly in group A and group B. Group A will receive PLB and group B will receive IS with baseline treatment chest percussions up to the duration of every day till discharge (reading will be collected on every 4rth day), dyspnea will be assessed through 6MWT and measured by Modified MRC dyspnea scale. The data will be analyzed through SPSS 26.

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
Single (Participant)

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age (45 to 70)
  • Type of Abdominal Surgery (Whipple Procedure) (11)
  • Gender (Male and Female)
  • Patients who has no history of pulmonary disease
  • Smokers and nonsmokers

排除标准

  • COPD (COPD patient with postoperative whipple procedure)
  • Heart patient (patients who had history of heart disease along with whipple procedure)
  • Uncontrolled Hypertension (patients who has have history of uncontrolled hypertension in postoperative whipple procedure)

结局指标

主要结局

Pulse Oximeter

时间窗: baseline and fourth week

Pulse oximetry is a simple and non-invasive method used to examine oxygen saturation (SpO2) in various parts of body. Convenient use, speed and high accuracy in detection of hypoxia and continuous monitoring of patients are other features of pulse oximetry

Modified MRC Dyspnea Scale

时间窗: baseline and fourth week

Medical Research Council (MRC) dyspnea scale the first clinical scale for the determination of dyspnea, is a 5-point scale based on the sensation of breathing difficulty experienced by the patient during daily life activities Patients, reading the 10 scale, are invited to recognize their own level of respiratory fatigue or, as is more often the case, the MRC can be directly administered

6-MWT

时间窗: baseline and fourth week

For the performance ability in many cardiopulmonary diseases, the most commonly used assessment tool is six minute walk test (6MWT). It has been widely used in research to evaluate the exercise capacity of various patient population (15). The test is standardized and reproducible self-paced exercise test. Patient is being asked to walk in a long hallway corridor for 6 minute between two cones on a flat surface. Ask the patient to keep walking. If the patient feels dyspnea, he or she may sit for a while. In healthy subjects with no history of pulmonary disease, the 6-min walk distance ranges from 400 to 700 m

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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