Pulmonary Expansion Device in Tracheostomized Patients Therapies in Tracheostomized Patients (NCT06075381) | Clinical Trial Compass
UnknownPhase 2
Pulmonary Expansion Device in Tracheostomized Patients Therapies in Tracheostomized Patients
50 participantsStarted 2024-02
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lung volumes
Timeframe: At three different time points: Day one, day three and day six following the removal of invasive ventilatory support