Clinical trial NCT06075381: Pulmonary Expansion Device in Tracheostomized Patients Therapies in Tracheostomized Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Postoperative Complications
Rehabilitation
Postoperative Care
Keywords: Inspiratory Capacity
Breathing Exercises
Self-help Devices
Inventions
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled, randomized, blinded, parallel-group, Phase II clinical study of applying conventional management plus the use of a lung reexpansion device versus conventional management alone as a lung reexpansion strategy in tracheostomized patients.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

To test secondary hypotheses 1 and 2, which state that the use of PED in addition to conventional management is a safe and effective strategy for improving postoperative oxygenation and lung volumes in tracheostomized patients, a comparison between the PED intervention and conventional management alone will be conducted for patients requiring lung reexpansion. This comparison will be achieved using repeated measures analysis of variance (ANOVA) or the non-parametric Friedman test, as appropriate.

For oxygenation, variables such as oxygen saturation (SaO2), arterial oxygen pressure (PaO2), and the ratio of arterial oxygen pressure to inspired oxygen fraction (PaFiO2) measured in arterial gases will be used. For lung volumes, measurements will include inspiratory vital capacity (IVC), IVC with PED, and tidal volume (Vt) as measured by the spirometer. Pulmonary pressures will involve maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). These measurements, taken at different postoperative time points, will be compared using repeated measures analysis of variance (ANOVA) or the non-parametric Friedman test, as appropriate.

Regarding secondary hypothesis 3, the proportion of patients with postoperative pulmonary complications between the comparison groups from intervention to the end of follow-up will be analyzed using the chi-square test or Fisher's exact test, as needed, to establish statistical significance.

A significance level of p\<0.05 will be considered statistically significant. All analyses will be conducted using STATA version 15.7.10.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Presence of signs of respiratory distress.
* Alteration in consciousness and loss of decision-making autonomy.
* Cervical spinal cord injury up to T1.
* 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).

Primary outcomes:
measure: Lung volumes
timeFrame: At three different time points: Day one, day three and day six following the removal of invasive ventilatory support
Secondary outcomes:
measure: Arterial oxygen pressure
timeFrame: At three different time points: Day one, day three and day six following the removal of invasive ventilatory support
measure: Postoperative pulmonary complication
timeFrame: Follow-up throughout hospitalization and up to 28 days from randomization
Other outcomes:
Locations:
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: MAURICIO VELASQUEZ GALVIS
role: STUDY_CHAIR
References: