Pulmonary Expansion Device in Tracheostomized Patients Therapies in Tracheostomized Patients (PEDTRAQ)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Complications; Rehabilitation; Postoperative Care
• Intervention / Treatment: Combination product: Pulmonary Expansion Device (PED); Procedure: Conventional management

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: ALVARO I SANCHEZ ORTIZ; Phone Number: +57 3183593663; Email: alvaro.sanchez@fvl.org.co
• Study Contact Backup: Name: ASTRID C ALVAREZ ORTEGA; Phone Number: +57 3175688544; Email: astrid.alvarez.or@fvl.org.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional management plus Pulmonary Expansion Device (PED); The conventional management used in the intensive care unit as a lung expansion strategy in patients with tracheostomy plus Pulmonary Expansion Device (PED).	Combination product: Pulmonary Expansion Device (PED); The Pulmonary Expansion Device constitutes an innovative instrumental technique for lung expansion, designed for use in patients with or without an artificial airway. This device is attached to the artificial airway, the oronasal mask, or the patient's mouth. It enables voluntary control through a system of one-way valves that restrict the air's escape from the lungs to the outside. This creates an environment conducive to retaining air within the lungs, thereby increasing intrapulmonary pressure. Additionally, it reduces the risk of pulmonary complications associated with conventional management, employing a strategy free from exogenous application of positive pressure to the airway. This approach doesn't necessitate expensive equipment or electrical power.; Procedure: Conventional management; The conventional management includes: Adequate postoperative pain control, global postural reeducation, reeducation of breathing pattern, airway hygiene, early mobilization, respiratory and scapular waist exercises, and in patients with evidence of lung atelectasis or mild persistent hypoxemia, conventional management will involve the use of intermittent positive pressure ventilation in the airway.
Active Comparator: Conventional management alone; Conventional management employed in the intensive care unit as a lung expansion strategy in tracheostomized patients, without utilizing the Pulmonary Expansion Device (PED).	Procedure: Conventional management; The conventional management includes: Adequate postoperative pain control, global postural reeducation, reeducation of breathing pattern, airway hygiene, early mobilization, respiratory and scapular waist exercises, and in patients with evidence of lung atelectasis or mild persistent hypoxemia, conventional management will involve the use of intermittent positive pressure ventilation in the airway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung volumes	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.	At three different time points: Day one, day three and day six following the removal of invasive ventilatory support

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial oxygen pressure	Describe oxygenation through arterial blood sample in tracheostomized patients requiring lung reexpansion therapy, where the use of PED plus conventional management is compared to conventional management alone	At three different time points: Day one, day three and day six following the removal of invasive ventilatory support
Postoperative pulmonary complication	Describe the frequency/proportion of postoperative pulmonary complications in tracheostomized patients requiring lung reexpansion therapy, where the use of PED plus conventional management is compared to conventional management alone	Follow-up throughout hospitalization and up to 28 days from randomization

Collaborators and Investigators

• Sponsor: Fundacion Clinica Valle del Lili
• Investigators: Study Chair: MAURICIO VELASQUEZ GALVIS, Fundacion Clinica Valle del Lili

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Breathing Exercises; Inspiratory Capacity; Self-help Devices; Inventions
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 02129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The Clinical Research Center (CRC) of the Fundacion Valle del Lili will generate and maintain all records related to patient selection, inclusion, and data tracking for the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No