Postoperative ComplicationsPhase 2PEDTRAQNCT06075381
Pulmonary Expansion Device in Tracheostomized Patients Therapies in Tracheostomized Patients
A Phase 2 study testing Pulmonary Expansion Device (PED) and Conventional management in people with Postoperative Complications and Rehabilitation, run by Fundacion Clinica Valle del Lili.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Postoperative Complications, Rehabilitation, Postoperative Care
- What is being tested?
- Pulmonary Expansion Device (PED) and Conventional management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Being tested
- Pulmonary Expansion Device (PED), Conventional management
- Keywords
- Inspiratory Capacity, Breathing Exercises, Self-help Devices, Inventions
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Expansion Device (PED)Combination product
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.
Conventional managementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional management plus Pulmonary Expansion Device (PED) | Experimental | The conventional management used in the intensive care unit as a lung expansion strategy in patients with tracheostomy plus Pulmonary Expansion Device (PED). Receives: Combination Product: Pulmonary Expansion Device (PED); Procedure: Conventional management |
| Conventional management alone | Active comparator | Conventional management employed in the intensive care unit as a lung expansion strategy in tracheostomized patients, without utilizing the Pulmonary Expansion Device (PED). Receives: Procedure: Conventional management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At three different time points: Day one, day three and day six following the removal of invasive ventilatory support
Secondary outcomes (2)
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
Measured: 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
Measured: Follow-up throughout hospitalization and up to 28 days from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study startFeb 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MAURICIO VELASQUEZ GALVIS, Study chair, Fundacion Clinica Valle del Lili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075381
- Sponsor's protocol ID
- 02129
- Acronym
- PEDTRAQ
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06075381
- Acronym / sponsor ID
- PEDTRAQ / 02129
- Keywords
- Inspiratory Capacity, Breathing Exercises, Self-help Devices, Inventions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional management plus Pulmonary Expansion Device (PED) | Experimental | Combination Product: Pulmonary Expansion Device (PED), Procedure: Conventional managementThe conventional management used in the intensive care unit as a lung expansion strategy in patients with tracheostomy plus Pulmonary Expansion Device (PED). |
| Conventional management alone | Active comparator | Procedure: Conventional managementConventional management employed in the intensive care unit as a lung expansion strategy in tracheostomized patients, without utilizing the Pulmonary Expansion Device (PED). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Conventional management plus Pulmonary Expansion Device (PED) |
| Conventional managementThe 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. | Procedure or surgery | Conventional management alone, Conventional management plus Pulmonary Expansion Device (PED) |
Primary outcome
Lung volumes
Time frame: 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.
2 secondary outcomes
Arterial oxygen pressure
Time frame: At three different time points: Day one, day three and day six following the removal of invasive ventilatory support
Postoperative pulmonary complication
Time frame: Follow-up throughout hospitalization and up to 28 days from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MAURICIO VELASQUEZ GALVIS study chair
Fundacion Clinica Valle del Lili
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pulmonary Expansion Device (PED) and Conventional management in people with Postoperative Complications and Rehabilitation, run by Fundacion Clinica Valle del Lili.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ALVARO I SANCHEZ ORTIZ (+57 3183593663, alvaro.sanchez@fvl.org.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung volumes (time frame: At three different time points: Day one, day three and day six following the removal of invasive ventilatory support). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.