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临床试验/NCT05532748
NCT05532748Unknown不适用

Distribution of Pulmonary Ventilation With the Modified Pachon Incentive vs. Another Branded Respiratory Incentive, Through Electrical Impedance Tomography, in a Healthy Volunteers of the City of Cali

Universidad del Valle, Colombia2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
18
试验地点
2
主要终点
EELI Delta (ΔEELI)

研究概览

简要总结

Incentive spirometry is a method to stimulate deep breathing and maximum sustained inflations, which provides participants with visual feedback on the inspiratory volume achieved, favoring lung inflation. Its multiple benefits and ease of use favor adherence, making it a common device used in the clinical environment.

This device is used in pathologies or procedures that can cause decreased function and respiratory mechanics, such as thoracoabdominal surgeries, and is indicated to reduce the incidence of postoperative pulmonary complications. It is also indicated in the presence of pulmonary atelectasis or conditions that predispose to the development of pulmonary atelectasis, in patients with prolonged bed rest, patients with neuromuscular disease, patients with spinal cord injury, and patients undergoing coronary bypass, among others.

In 2004, students from the Universidad del Valle carried out an investigation whose result was the creation of the Incentivo Modificado de Pachon, a handcrafted design device that allows mobilizing flows ranging from 600 CC/sec to more than 1400 CC/sec, which characterizes it as a flow respiratory incentive.

In 2020, the device obtained the endorsement of the Superintendence of Industry and Commerce, however, to date no studies have been carried out that objectively verify the effect that the modified Pachon's incentive (Incentivo Modificado de Pachon by the name in Spanish) has on the distribution of ventilation in comparison with another Branded respiratory incentive.

Electrical Impedance Tomography is a diagnostic tool that, employing a belt of electrodes connected around the user's chest, uses the electrical characteristics of the tissue, to provide information in a non-invasive, continuous way, on foot. bedside and radiation-free on pulmonary ventilation and perfusion, as it allows repeated imaging of tidal volume distribution, as well as distinguishing the characteristic regional filling and emptying of each lung, all in real-time and safely.

In this study, the distribution of pulmonary ventilation between the modified Pachon's incentive vs. another Branded respiratory incentive will be compared, through electrical impedance tomography, in a healthy population of the city of Cali.

The hypothesis to be tested is that the distribution of Pulmonary ventilation measured by Electrical Impedance Tomography is similar between the modified Pachon's incentive and another Branded flow respiratory incentive.

详细描述

The variables to be measured are:

Main variables:

  • EELI Delta (ΔEELI): Measures the change in the average end-expiratory pulmonary impedance before and after an intervention
  • MTV ROI: Minute regional tidal variation

Secondary variables:

  • IPAQ: Instrument that provides information on estimated energy expenditure in 24 hours in the different areas of daily life
  • Charlson index: Relates long-term mortality with the participant's comorbidity
  • %FEV1 pred: Percentage of the predicted forced expired volume in the first second
  • %FVC pred: Percentage of predicted forced vital capacity
  • %FVC/FEV1: Percentage of predicted of relationship between forced vital capacity and FEV1
  • Labor Occupation: Includes the labor function of the worker
  • Level of schooling: the highest level of studies completed or in progress
  • Marital status: situation determined by your family relationships, from marriage or kinship
  • Socioeconomic Stratum: Classification in strata of residential properties
  • Personal history: Compilation of information on the health of the person and pathologies that he/she suffers from
  • Height: Measurement of the height of the human body from the feet to the roof of the cranial vault
  • Weight: Force with which bodies are attracted towards the center of the earth by the action of gravity
  • BMI: Relationship between weight and height
  • Heart rate: Number of times the heart contracts in one minute
  • Respiratory rate: Number of breaths in one minute
  • Oxygen Saturation: Measurement of the amount of oxygen available in the blood
  • Dyspnea: Difficulty breathing

研究设计

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

盲法说明

The outcomes assessor of results will be masked, the data will be delivered encrypted with a code for the analysis of the measurement of each of the respiratory incentives.

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

入选标准

  • People aged between 18-65 years
  • People with clinical stability, defined as the absence of any acute illness during the previous 6 weeks and a Charlson index score of 0-1 (12% mortality/year- no comorbidity)
  • People with body mass index (BMI) 18.5 - 35 Kg/m2
  • People without mental or cognitive alterations
  • People who accept informed consent

排除标准

  • People with pacemakers, cardioverters or cardio defibrillators.
  • People with metal implants
  • People with any condition in which the registration in the CT scanner signal is low.
  • Women in pregnancy
  • Participants with injuries, skin changes or presence of devices that prevent the placement of the electrode belt around the chest.
  • People with a high level of physical activity according to the IPAQ questionnaire short version
  • People whose spirometry registers obstruction or restriction
  • People who do not understand the verbal command of the incentive technique

结局指标

主要结局

EELI Delta (ΔEELI)

时间窗: Event 1 "pre": after the first 2 minutes of calm breathing. Event 2 "intra": In the last repetition of the third series of the use of the device. Event 3 "post": 2 minutes after finishing the three series of 10 repetitions

Measures the change in the average end-expiratory pulmonary impedance between before and after an intervention. Measurement Unit: Arbitrary Impedance Units (A.U)

MTV ROI

时间窗: Event 1 "pre": after the first 2 minutes of calm breathing. Event 2 "intra": In the last repetition of the third series of the use of the device. Event 3 "post": 2 minutes after finishing the three series of 10 repetitions

Minute regional tidal variation. Measurement Unit: Arbitrary Impedance Units (A.U)

次要结局

  • Heart rate(after two minutes of calm breathing, after two minutes of the use of each respiratory incentive)
  • Oxygen saturation(after two minutes of calm breathing, after two minutes of the use of each respiratory incentive)

研究者

发起方
Universidad del Valle, Colombia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esther Cecilia Wilches Luna

Full professor

Universidad del Valle, Colombia

研究点 (2)

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