Cardiopulmonary rehabilitation post lung transplant for Respiratory Aspiration

Phase-Based Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Florida, Jacksonville, FL
Respiratory Aspiration+2 More
Cardiopulmonary rehabilitation post lung transplant - Other
Eligibility
18+
All Sexes
Eligible conditions
Respiratory Aspiration

Study Summary

This study is evaluating whether training the inspiratory muscles can improve exercise capacity, quality of life, and short-term clinical outcomes in patients post lung transplant.

See full description

Eligible Conditions

  • Respiratory Aspiration
  • Bronchiectasis
  • Post-Lung Transplantation Bronchiectasis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Cardiopulmonary rehabilitation post lung transplant will improve 1 primary outcome, 1 secondary outcome, and 2 other outcomes in patients with Respiratory Aspiration. Measurement will happen over the course of 12 weeks.

12 weeks
Maximal inspiratory mouth pressure (MIP) measured in cmH2O
Maximal oxygen uptake (V̇O2max) measured in mL/kg/min
Peak work rate (Wpeak) (watts)
Six-minute walk test distance (6MWTd) measured in meters (m)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle
12-weeks pulmonary rehabilitation training plus inspiratory muscle training
Placebo group

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cardiopulmonary Rehabilitation Post Lung Transplant is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

12-weeks pulmonary rehabilitation training plus inspiratory muscle trainingTo assess maximum inspiratory pressure, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home.
12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscleTo assess maximum inspiratory pressure with placebo, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home. The resistance will be set to about 5% throughout the study.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 weeks for reporting.

Who is running the study

Principal Investigator
B. T.
Bryan Taylor, Principal Investigator
Mayo Clinic

Closest Location

Mayo Clinic in Florida - Jacksonville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
- All patients who undergo single- or double-lung transplant at Mayo Clinic Florida.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of respiratory aspiration?

Add answer

The following signs (in summary, ordered by frequency) can be used to highlight specific areas for which clinicians and caregivers need to be educated and trained as to their signs and symptoms:\n\n- Drooling\n- Rapid wheezing\n- Coughing up blood\n- Mucus\n- Fever\n- Lethargy\n- Vomiting\n\nSigns are often related through their shared underlying pathophysiology.

Unverified Answer

What are common treatments for respiratory aspiration?

Add answer

The treatment of respiratory aspiration is based on the specific cause. Nonopioid analgesics, in particular, aspirin, are commonly prescribed for those children with gastroesophageal reflux disease who present with air entry into the trachea. Children hospitalized with respiratory aspiration usually receive antipyretic drugs for the primary treatment, such as ibuprofen and amoxicillin/clavulanic acid for children hospitalized with viral pneumonia. Those children with respiratory aspiration secondary to gastroesophageal reflux disease or foreign objects (e.g., coins, glass chips, popcorn grains) may be treated with an H2RA, such as ranitidine.

Unverified Answer

Can respiratory aspiration be cured?

Add answer

Respiratory aspiration is not curable because [its natural history is far from being completely understood] and more will be needed before effective interventions can be developed to prevent aspiration. However, in this light, patients with respiratory distress as a result of aspiration should be screened, managed and monitored with caution.

Unverified Answer

What causes respiratory aspiration?

Add answer

Aspiration is an issue in children. The number of potential contributing factors is far too many to consider. It is, therefore, more useful to consider the specific child; the environment in which the child is educated and cared for: as a potential contributing factor to aspiration. A full history, examination and appropriate investigation is required.

Unverified Answer

What is respiratory aspiration?

Add answer

Respiratory aspiration is a condition in which a food bolus slides down the esophagus and enters the submandibular space, ending up in blood vessels around the tongue and gums. There can be serious consequences including pneumomediastinum, subcutaneous emphysema and airway obstruction.

Unverified Answer

How many people get respiratory aspiration a year in the United States?

Add answer

A significant number of adults have experienced an episode of respiratory aspiration at some point. This is even more likely among seniors. The increased rates of asthma and COPD over time have been linked to the increase in respiratory aspiration.

Unverified Answer

Who should consider clinical trials for respiratory aspiration?

Add answer

Consideration by patients or their families is necessary for enrollment in these trials. Clinicians should counsel patients on the risks and benefits of enrollment in these trials.

Unverified Answer

What is the average age someone gets respiratory aspiration?

Add answer

Respiratory aspiration is a serious medical condition that can lead to death. It most commonly occurs due to eating food or liquids that contain foreign objects, such as a peanut or food from a candy dispenser. Younger people, men, and those with a chronic illness and/or disability are more likely to get respiratory aspiration. When eating, eat quickly and put food into one's mouth so it does not settle on the back of the throat. If someone eats food without pushing it down the throat, food falls into the airway. As food is swallowed, fluid in the food comes along with it. The fluid also settles and blocks the airway, leading to a breathing problem.

Unverified Answer

What is the latest research for respiratory aspiration?

Add answer

Patient safety depends upon the patient's specific health conditions, the clinical area of medical practice and the provider. Therefore, patients with health services associated with respiratory aspiration are at particular risk from adverse effects of inhaled agents. Respiratory aspiration prevention depends on education. More studies with a large sample size are needed to determine whether it is safe and the most appropriate method for prevention.

Unverified Answer

What are the common side effects of cardiopulmonary rehabilitation post lung transplant?

Add answer

Data from a recent study found that two common side effects of cardiopulmonary rehabilitation are reduced breathing effort and the transient onset of a sense of dizziness. Both of these are found to be transient and are not directly linked to any of the treatment given in this study. Data from a recent study of this study do not preclude those who are undergoing cardiopulmonary rehabilitation to experience some of these common side effects. This information will allow clinicians to manage these people more efficiently and competently.

Unverified Answer

What is cardiopulmonary rehabilitation post lung transplant?

Add answer

A structured, standardized program incorporating aerobic exercise and psychosocial components can significantly increase quality of life for the lung transplant recipient and improve survivability of the transplanted lungs.

Unverified Answer

What is the primary cause of respiratory aspiration?

Add answer

Patients with neuromuscular disease, including muscular dystrophy, are at very high risk for accidental aspiration of food and drinks. Patients are frequently given prophylactic medications against aspiration, but these agents fail to prevent all instances of aspiration. We hypothesize that patients require intensive therapy to avoid aspiration.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Respiratory Aspiration by sharing your contact details with the study coordinator.