CLINICAL TRIAL

Process for Respiratory Failure

Recruiting · 18+ · All Sexes · New York, NY

This study is evaluating whether live music therapy may help reduce the amount of time a patient needs to be on a ventilator.

See full description

About the trial for Respiratory Failure

Eligible Conditions
Acute Lung Injury · Respiratory Distress Syndrome, Acute (ARDS) · Hypoxemic Acute Respiratory Failure · Respiratory Insufficiency · Acute Hypercapnic Respiratory Failure · Respiratory Distress Syndrome · Respiratory Distress Syndrome, Newborn

Treatment Groups

This trial involves 4 different treatments. Process is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Toning
OTHER
Experimental Group 2
Process
BEHAVIORAL
Experimental Group 3
Holding Harmonic Container
OTHER
Show More

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients that are anticipated to need invasive mechanical ventilation for more than 48 hours will be screened to see if they want to participate in the study. show original
were treated with bilevel positive airway pressure (BiPAP) or continuous positive airway pressure (CPAP) for 7 days show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 15 minute intervals over 30 minute intervention
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 minute intervals over 30 minute intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 15 minute intervals over 30 minute intervention.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Process will improve 1 primary outcome and 11 secondary outcomes in patients with Respiratory Failure. Measurement will happen over the course of average 14 days.

ICU length of stay
AVERAGE 14 DAYS
AVERAGE 14 DAYS
Cumulative Length of Stay in Hospital
AVERAGE 14 DAYS
AVERAGE 14 DAYS
Cumulative Length of Time on Ventilator
AVERAGE 14 DAYS
AVERAGE 14 DAYS
Amount of sedation
14 DAYS
14 DAYS
State-Trait Anxiety Inventory (Short Form)
14 DAYS
To calculate the total STAI score (range 20-80): Reverse scoring of the positive items (calm, relaxed, content) so 1=4, 2=3, 3=2, and 4=1; Sum all six scores; Multiply total score by 20/6 Scores are interpreted such that a "normal" score is approximately 24-36, Higher score indicates more anxiety
14 DAYS
Pain score
14 DAYS
Numeric Pain Score (for enrollees able to speak). Pain score from 0 (no pain) to 10 (most pain)
14 DAYS
See More

Who is running the study

Principal Investigator
J. L.
Joanne Loewy, Director, Louis Armstrong Center for Music and Medicine at Mount Sinai Beth Israel
Icahn School of Medicine at Mount Sinai

Patient Q & A Section

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

Can respiratory failure be cured?

Results from a recent paper shows that the treatment with levosalbutamol or dexamethasone results in resolution of both the cardiorespiratory and neurological manifestations of RFR. The use of beta adrenergic receptor antagonists or anticholinergic agents failed to produce a significant change in the oxygenation status of patients with RFR requiring supplemental oxygen saturation, which suggests that RFR is more a cardiovascular issue. We thus conclude that the treatment with inhaled bronchodilators or anticholinergics, which are commonplace in the treatment of RFR, might be considered as a possible treatment option. However, this must be clarified by an extensive randomized controlled trial.

Anonymous Patient Answer

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

About 4,050,000 people in the US experience respiratory failure every year. The number is estimated to be over twice the amount of cardiovascular disease deaths (2,150,000) and more than double the number of cancer deaths (1,380,000). Most will receive help due to age (65% are 65 years old or older) and be hospitalized (35% are hospitalized in the 30 days before the beginning of the crisis). Most will live longer after the crisis subsides (50%, or 1,800,000) if cared for appropriately and with continuity of care.

Anonymous Patient Answer

What is respiratory failure?

Pulmonary edema has been called 'the silent killer of children'. It is commonly unrecognised after a child has collapsed into a hospital bed and is often fatal if left untreated. Pulmonary edema occurs in 15% of infants who die in the first year of life, and more in the first 6 months of life. A number of factors predispose in particular situations to pulmonary edema and may help identify those children at the highest risk, and who are likely to benefit from aggressive management. Pulmonary edema is seen when the right ventricle is too dilated because the blood vessels have lost their ability to stretch.

Anonymous Patient Answer

What are the signs of respiratory failure?

Most people with respiratory failure can easily recognise their onset of respiratory failure because they may experience difficulty talking or swallowing, breathlessness or chest pain on waking. It is important to recognise the early signs of a respiratory problem and seek help to prevent complications such as inadequate oxygenation and an accumulation of fluid in the lung. Signs such as an increased rate of breathing (tachypnea), enlarged chest and the presence of crackles/rhonchi (fine rales around the lungs) on auscultation are more specific.

Anonymous Patient Answer

What causes respiratory failure?

Respiratory failure may be due to diseases of different organs. Each pathogen has particular causes, and the diagnosis of respiratory failure should be based on clinical evaluation and radiographic studies if they are available in the hospital. In patients without clinical evidence of respiratory infection, a lung radiograph alone should guide the diagnostic evaluation. There are five major types of respiratory failure. Each of these types can be further subdivided based on the inciting pathology. An appropriate differential diagnosis can be difficult to obtain in some critically ill patients with pulmonary edema. Appropriate management of respiratory failure depends on which disease underlies it.

Anonymous Patient Answer

What are common treatments for respiratory failure?

Respiratory failure, especially ARDS, usually can be treated with the administration of corticosteroids, surfactant, or plasma exchange. In certain cases, ECMO can also be considered, especially when ARDS is complicated by acute kidney injury.

Anonymous Patient Answer

Have there been any new discoveries for treating respiratory failure?

There were no new treatments for respiratory failure published since 1999, except for a small number of clinical trials underway using anti-infectives. Antibiotics have recently received increased attention in the treatment of ventilator-associated pneumonia (VAP), which is one of the most common complications in mechanically ventilated [ICU/SICU patients]. The role of antimicrobial therapy in prevention of VAP, especially in patients with neutropenia who has undergone autologous stem cell transplantation, is under investigation. A multicenter randomized clinical trial, funded by the National Institutes of Health, will open in September 2021 (NCT 02981152).

Anonymous Patient Answer

Have there been other clinical trials involving process?

As is shown for the randomized controlled trial of inhaled nitric oxide for acute pulmonary hypertension, the process of the study impacts the study, and is essential for the validity and effectiveness of results as clinical treatments come to be evaluated and accepted. In these trials the conduct of the study in and in-between its elements can lead to bias, as the treatment used and results are altered by the fact that the trial was done according to their protocol. This is in particular true when a control group is not included in the study [Power(https://www.withpower.com/trial-design/control-groups).

Anonymous Patient Answer

What is the latest research for respiratory failure?

All of our questions are covered in the articles listed. It's a complex area with more research needed. There is research suggesting ventilation modes other than pressure support ventilation will improve survival in patients with acute respiratory failure, and some research suggests oxygen use during high-flow oxygen therapy could potentially improve outcomes compared to conventional oxygen delivery to patients with respiratory failure. There is also evidence of improving outcomes with more conservative use of antibiotics in the critically ill, and we could all appreciate the relevance of better treatment of people with acute respiratory failure. Current best practice recommendations remain consistent in helping providers in this area, and research continues for improved ways to use ventilatory support.

Anonymous Patient Answer

Does process improve quality of life for those with respiratory failure?

Continuous process-based education did not result in better quality of life outcomes compared to a traditional educational approach irrespective of baseline performance status, level of health education, or readiness for self management, suggesting that process-based education may be harmful for persons with respiratory failure.

Anonymous Patient Answer

What are the common side effects of process?

The overall magnitude of the problems is not as high as has been believed before and it seems likely now that problems are being perceived and reported by a greater number of people for two reasons: First, people now notice and talk about common problems more readily; second, the general quality of the care provided to them improved and this led them to be more accepting of them.

Anonymous Patient Answer

What is the average age someone gets respiratory failure?

Respiratory failure is a more severe illness in younger patients. It is not just a consequence of poor quality of care - other factors such as decreased lung volumes or lung diffusion capacity make it a debilitating illness. Increasing awareness and treatment of the respiratory failure risk for young adults with severe lung disease may improve their lung function and prolong survival.

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