Music therapy plus standard care during an SBT for Intubations

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Medical University of South Carolina, Charleston, SC
Intubations+4 More
Music therapy plus standard care during an SBT - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether music therapy can improve breathing during a breathing trial.

See full description

Eligible Conditions

  • Intubations
  • Spontaneous Breathing Trial
  • Ventilations, Mechanical
  • Music Therapy

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Music therapy plus standard care during an SBT will improve 1 primary outcome and 5 secondary outcomes in patients with Intubations. Measurement will happen over the course of Up to 48 hours after the participant's initial SBT..

At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT
Mean score of agitation as assessed by the Richmond Agitation-Sedation Scale at points throughout SBT
Mean score of blood pressure at points throughout SBT
Mean score of heart rate at points throughout SBT
Mean score of respiratory rate at points throughout SBT
Hour 48
Mean minutes sustained off ventilator support for failed SBTs
Proportion of successful initial spontaneous breathing trials (SBTs) vs failed initial SBTs

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Standard Care
1 of 2
Music Therapy plus Standard Care
1 of 2
Active Control
Experimental Treatment

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Music Therapy Plus Standard Care During An SBT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Music Therapy plus Standard Care
Other
Music therapy intervention in addition to standard hospital care during an SBT.
Standard Care
Procedure
Standard hospital care during an SBT.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at minute 0 of the sbt, 10 minutes into the sbt, and 30 minutes into the sbt
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at minute 0 of the sbt, 10 minutes into the sbt, and 30 minutes into the sbt for reporting.

Who is running the study

Principal Investigator
M. R.
Macel Reising, Music Therapist
Medical University of South Carolina

Closest Location

Medical University of South Carolina - Charleston, SC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adults 18+
Admitted to MUSC's Main Hospital medical intensive care unit (MICU) or Ashley River Tower medical-surgical intensive care unit (MSICU)
Intubated and will undergo a spontaneous breathing trial

Patient Q&A Section

What are the signs of respiratory aspiration?

"Signs of respiratory aspiration present during the episode include cough, a productive cough, wheezing, dyspnea, dyspnea in the evening, nasal congestion, and nasal discharge. Episodes can be identified by their rapid onset and a chronic course that requires ongoing care." - Anonymous Online Contributor

Unverified Answer

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

"Approximately 1 million episodes of aspiration pneumonia occur each year in the United States, with an average of 2.2 episodes per 100,000 live births. Most cases occur in children younger than 2 years of age, in persons >50 years of age, and in the nondiabetic. This underscores the high risk of aspiration pneumonia and the need to provide effective prevention strategies in order to reduce morbidity and mortality in this age group." - Anonymous Online Contributor

Unverified Answer

Can respiratory aspiration be cured?

"Respiratory aspiration is a curable aspiration with good treatment and supportive therapy. A careful record of preoperative history, physical examination and chest radiography facilitates a good management plan. Respiratory aspiration can not only be cured but also may actually be a path to cure itself." - Anonymous Online Contributor

Unverified Answer

What is respiratory aspiration?

"Respiratory aspiration is the act of inhaling food or liquid into the trachea or bronchial tree. It occurs frequently, especially in the hospital setting. The underlying conditions are serious and have been associated with increased mortality." - Anonymous Online Contributor

Unverified Answer

What causes respiratory aspiration?

"This is a common cause of death. Most deaths are due to choking, and some can be prevented through a simple method of clearing the airway before choking occurs. The number of fatalities due to this cause is increasing with the increasing numbers of people with underlying lung disease in Australia. The reasons for this appear to be ageing and increasing prevalence of asthma or chronic obstructive pulmonary disease, as well as a growing number of middle-aged or older adults." - Anonymous Online Contributor

Unverified Answer

What are common treatments for respiratory aspiration?

"Specific prevention, early identification, and timely intervention of respiratory aspiration are key to the best outcome. There is an urgent need to develop and implement evidence-based protocols for the immediate treatment of respiratory aspiration in both outpatients and hospital settings by trained healthcare providers." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving music therapy plus standard care during an sbt?

"Music therapy plus standard care is well tolerated. Results from a recent paper of this trial will be analyzed and reported within six months from completion of enrollment." - Anonymous Online Contributor

Unverified Answer

What is the latest research for respiratory aspiration?

"There is no convincing evidence for benefit of oral sucralfate in treating acute respiratory inflammation due to recent aspiration. There is little strong evidence that sucralfate is effective in chronic aspiration-associated bronchitis. While there is some evidence of benefit from sucralfate in chronic aspiration-associated bronchitis, it is doubtful that it is effective enough to recommend its use in the longer term." - Anonymous Online Contributor

Unverified Answer

Does respiratory aspiration run in families?

"Respiratory aspiration ran in our family as suggested by the clinical features and radiological findings. The familial pattern is not explained by a predominant genetic background of aspiration or by environmental factors." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of music therapy plus standard care during an sbt?

"Music therapy, when applied as indicated and without overstimulation, is a safe therapy that is well tolerated. For further progress, the effect of music therapy per se needs to be studied. Implications of the present data for future clinical trials are, therefore, discussed." - Anonymous Online Contributor

Unverified Answer

How does music therapy plus standard care during an sbt work?

"The study shows that musical therapy can improve the quality of life in patients with sbt. There was no improvement in the symptoms or duration of sbt." - Anonymous Online Contributor

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