Randomized Controlled Study on T-PEP Versus IPV Method for Lower Respiratory Airways Clearance in… (NCT04142814) | Clinical Trial Compass
WithdrawnNot Applicable
Randomized Controlled Study on T-PEP Versus IPV Method for Lower Respiratory Airways Clearance in Tetraplegic Tracheotomized Spinal Cord Injured Patients
Stopped: Patients case mix changed and did not match anymore with selection criteria
Italy0Started 2022-02
Plain-language summary
In tetraplegic patients with complete cervical spinal cord injury, respiratory complications are very frequent, especially in the sub-acute phase: the lungs often become obstructed due to the accumulation of secretions and the contemporary inefficiency of the cough mechanism. The present pilot study aims, in the context of a rehabilitative Critical Care Unit, at evaluating a not yet published method, called "T-PEP" and based on the principle of Positive Expiratory Pressure, applicable to tracheotomised and mechanically ventilated patients. This method, conceptually simple and low cost, is compared with a known method based on the principle of Percussive Intrapulmonary Ventilation (IPV). Safety and efficacy issues are covered.
Who can participate
Age range
18 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:
* spinal cord injury due to traumatic or non-traumatic etiology;
* neurological level from C4 to C7 (included)
* complete spinal cord injury, classifiable as "A" grade according to the Asia Impairment Scale (AIS);
* distance from the spinal cord injury event from 1 to 5 weeks;
* first admission to Montecatone R.I. (in particular to the Critical Care Unit);
* patients with middle-basal hypoventilation;
* patients in partial or continuous mechanical ventilation;
* patients with tracheotomy;
* patients capable of giving meaningful consent;
* collaborating patients.
Exclusion Criteria:
* thoracic trauma with non-drained thoracic fractures and / or pneumothorax and / or hemorrhage;
* pleural effusion;
* significant hemodynamic instability needing amines administration and / or Shock Index \> 1.5;
* patients with tracheoesophageal fistulae;
* patients with severe acquired brain injury;
* patients with ongoing sepsis;
* patients with ongoing pregnancy.
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
Incidence of adverse events
Timeframe: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) until the following 4 weeks
Trial details
NCT IDNCT04142814
SponsorMontecatone Rehabilitation Institute S.p.A.