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临床试验/NCT04418700
NCT04418700已完成不适用

Effects of the Breath Stacking Technique After Upper Abdominal Surgery: Randomized Controlled Trial

Universidade Federal de Santa Maria1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年6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
已完成
入组人数
32
试验地点
1
主要终点
Change from second postoperative day forced vital capacity (FVC) at 7th postoperative day or hospital discharge.

研究概览

简要总结

This study evaluates the effects of the breath stacking technique in patients after upper abdominal surgery. Half of the patients receive routine physical therapy associated with the Breath Stacking technique, while the other half will receive only routine physical therapy.

详细描述

This randomized controlled study aims to evaluate the effects of the Breath Stacking technique in patients undergoing upper abdominal surgery on clinical, physiological and cardiopulmonary variables. These individuals were randomized to compose the control group (CG) and the intervention group (GBS). The routine physical therapy was performed in both groups and in the GBS two daily sessions of up to 20 minutes of Breath Stacking technique were applied. To verify the effect of this intervention, before and after the protocol, patients underwent the following evaluations: algometry, cirtometry in the axillary line , umbilical line and the xiphoid process, ventilometry, spirometry and manovacuometry.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing a surgical procedure that involves in an incision in the upper quadrants of the abdominal region.

排除标准

  • •Intolerance to the use of BS mask.
  • •Chronic obstructive pulmonary disease (COPD), Asthma, Chron's disease.
  • •Liver trauma severe with hemodynamic repercussions.
  • •Patients undergoing esophagectomy.
  • •Sepsis with complications postoperative hemodynamics.
  • •Need for surgical reintervention.
  • •Forwarded to Intensive Care Unit or need for mechanical ventilation after discharge from the anesthetic recovery.
  • •Cognitive dysfunction that makes it impossible to understand and execute evaluations and intervention.

研究组 & 干预措施

Breath Stacking technique

Experimental

The intervention group will receive routine physical therapy associated with the Breath Stacking technique in 2 daily sessions of up to 20 minutes.

The technique consists of an Instrument composed of a one-way valve coupled to a face mask to promote the accumulation of successive inspiratory volumes.

干预措施: Breath Stacking (Device)

Routine physical therapy

No Intervention

The control group will receive only routine physical therapy. Routine physiotherapy consists of breathing exercises, using techniques bronchial hygiene and pulmonary reexpansion, and motor physiotherapy through exercise passive, active-assisted or active mobilization, stretching, training activities of daily living, positioning and removal of the bed and guidelines for post-discharge.

结局指标

主要结局

Change from second postoperative day forced vital capacity (FVC) at 7th postoperative day or hospital discharge.

时间窗: The change in FVC will be evaluated on the 2nd postoperative day and up to 7th postoperative day.

The FVC will be evaluated as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability \<5%) and considered the best curve for the study.

Change from second postoperative day tidal volume at 7th postoperative day or hospital discharge.

时间窗: The change in tidal volume will be evaluated on the 2nd postoperative day and up to 7th postoperative day.

Tidal volume will be obtained through the division of the minute volume by the respiratory rate.

次要结局

  • Forced expiratory volume in the first second (FEV1)(It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.)
  • Blood pressure(These will be evaluated on the 2nd postoperative day and up to 7th postoperative day. These will also be measured before and after the first and last BS session.)
  • Painful perception in the surgical incision(It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.)
  • Peak expiratory flow (PEF)(It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.)
  • Respiratory muscle strength(These will be evaluated on the 2nd postoperative day and up to 7th postoperative day.)
  • Minute volume(It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.)
  • Heart rate(It will be evaluated on the 2nd postoperative day and up to 7th postoperative day. This variable will also be measured before and after the first and last BS session.)
  • Respiratory rate(It will be evaluated on the 2nd postoperative day and up to 7th postoperative day. This variable will also be measured before and after the first and last BS session.)
  • Peripheral oxygen saturation (SpO2)(It will be evaluated on the 2nd postoperative day and up to 7th postoperative day. This variable will also be measured before and after the first and last BS session.)
  • Thoracoabdominal mobility(It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.)
  • FEV1 / FVC ratio (FEV1 / FVC)(It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.)
  • Rates of gastrointestinal symptoms (pain abdominal, nausea, vomiting)(These will be evaluated before and after the application of the BS technique (therefore, only in GBS) on the 2nd postoperative day and up to 7th postoperative day.)
  • Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)(It will be evaluated on the 2nd postoperative day and up to 7th postoperative day.)
  • Degree of dyspnea(It will be evaluated before and after the application of the BS technique (therefore, only in GBS) on the 2nd postoperative day and up to 7th postoperative day.)
  • Rates of signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature)(These will be evaluated before and after the application of the BS technique (therefore, only in GBS) on the 2nd postoperative day and up to 7th postoperative day.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Antônio Marcos Vargas da Silva

Principal Investigator

Universidade Federal de Santa Maria

研究点 (1)

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