Safety and Efficacy of the Pulmonary Expansion Device (PED): A Novel Postoperative Pulmonary Reexpansion Strategy Using Negative Pressure Generation for the Management of Tracheostomized Patients - Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Lung volumes
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of using PED (Pulmonary Expansion Device) in tracheostomized patients requiring lung reexpansion therapy within a single institution. The main question it aims to answer is: In tracheostomized patients requiring lung reexpansion therapy, does the utilization of PED (Pulmonary Expansion Device) alongside conventional management constitute a safe and effective strategy for improving oxygenation, lung volumes, and reducing postoperative pulmonary complications, as compared to traditional management alone?
Researchers will compare lung expansion therapy with PED plus conventional management versus lung expansion therapy through conventional management in tracheostomized patients to assess the safety and efficacy in terms of improvement in oxygenation, lung volumes, and reduction of postoperative pulmonary complications.
详细描述
Sample size: Considering that the utilization of the PED introduces an innovative approach to the standard postoperative care of tracheostomized patients, who inherently face an elevated risk of pulmonary complications due to glottis derivation and are unable to engage in traditional respiratory exercises, there is currently an absence of information within the reviewed scientific literature concerning any device employed for evaluating gasometry and lung volume within this specific target population. Consequently, a comparable population that has undergone lung reexpansion techniques is not present for reference in this context. Therefore, when it comes to calculating the sample size, our only available reference is our pilot study involving 10 tracheostomized patients who underwent a lung reexpansion strategy using the PED. This study demonstrated noticeable improvements in oxygenation and lung volumes without encountering any related complications.
As a result, the sample size for this feasibility study has been adjusted based on the number of recently tracheostomized patients admitted to the Adult Intensive Care Unit. Concurrently in the immediate postoperative phase following thoracic surgery (41 patients) or high abdominal surgery (16 patients) throughout the year 2021. Consequently, it was determined that data would be collected from a cohort of 50 patients who meet the predefined inclusion criteria over one year. Both the intervention and control groups will be randomized equally. This Phase 2 study aims to provide essential feasibility parameters that facilitate a more precise estimation of the required sample size, specifically within the distinct population of tracheostomized individuals requiring lung reexpansion therapy.
Statistical Analysis: All analyses will be conducted using an intention-to-treat analysis, taking into account the treatment received by each patient in each group following randomization. If a patient's health condition changes and they require invasive ventilatory support for more than 24 consecutive hours or are unable to participate in the intervention, they will be excluded based on exclusion criteria. Blinding will be lifted, and such cases will not be included in the analysis.
For data presentation, for variables with a normal distribution, the measure of central tendency summarizing the data will be the mean, and the standard deviation will be used as a measure of dispersion. When the distribution is non-normal, data will be summarized using the median and interquartile range for continuous variables. Categorical variables will be reported as percentages and presented in frequency tables.
Continuous variables will be analyzed using a Student's t-test for normally distributed data or the Mann-Whitney test for non-parametric data. Categorical variables will be compared using the chi-square test or Fisher's exact test.
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
Due to the nature of the intervention, it is not feasible to mask the treatment in the control group and intervention group, although both groups will receive a standard treatment. One group will receive treatment through the use of the PED, while the other group will receive treatment through intermittent positive pressure in cases of lung atelectasis or mild persistent hypoxemia.
After obtaining informed consent from eligible participants, the assignment to the therapeutic group will be carried out using a code that does not openly indicate the assigned group. Individuals aware of the assignment will be the physiotherapists administering the interventions and collecting data in the electronic format, which will be isolated from the data analysis. Generating these codes for each patient aims to blind the interventions during the statistical analysis process. All information will be recorded in electronic format.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 and older.
- •Patients with a tracheostomy tube equipped with a functional cuff.
- •Patients exhibiting spontaneous breathing for a period exceeding 24 hours.
- •Patients requiring lung reexpansion techniques (Postoperative period following thoracic or high abdominal surgery, thoracic trauma, rib fracture, among others).
- •Chest imaging confirming the absence of pulmonary parenchyma alterations.
排除标准
- •Presence of signs of respiratory distress.
- •Alteration in consciousness and loss of decision-making autonomy.
- •Cervical spinal cord injury up to T
- •Muscular weakness due to neuro-demyelinating or peripheral nerve disease.
- •Complete dependence on ventilatory support.
- •Intracranial pressure greater than 20 mmHg.
- •Poorly controlled pain with a Visual Analog Scale (VAS) score of 5 or more.
- •Presence of nausea or vomiting.
- •Active hemoptysis.
- •Pulmonary edema.
- •Decompensated congestive heart failure New York Heart Association (NYHA) III-IV.
- •Severe physical deconditioning.
- •Chronic Obstructive Pulmonary Disease (COPD) Gold E.
- •Patients for whom lung reexpansion techniques are contraindicated (pulmonary bullae, pulmonary fistulas, unresolved pneumothorax or hemothorax, medically managed primary spontaneous pneumothorax, platelet count <50,000, among others).
结局指标
主要结局
Lung volumes
时间窗: At three different time points: Day one, day three and day six following the removal of invasive ventilatory support
Describe the lung volumes through measurements with a Wright respirometer in tracheostomized patients requiring lung reexpansion therapy, where the use of PED plus conventional management is compared to conventional management alone.
次要结局
- Postoperative pulmonary complication(Follow-up throughout hospitalization and up to 28 days from randomization)
- Arterial oxygen pressure(At three different time points: Day one, day three and day six following the removal of invasive ventilatory support)