Feasibility of Music Therapy for Spontaneous Breathing Trials
- Conditions
- Spontaneous Breathing TrialIntubationMechanical VentilationMusic Therapy
- Interventions
- Procedure: Standard care during an SBTOther: Music therapy plus standard care during an SBT
- Registration Number
- NCT05008328
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
In this study, the investigators will study music therapy for patients during breathing trials, a procedure performed in intensive care units. Participants will be assigned either to standard medical care or standard medical care plus music therapy. Participants have a 50/50 chance (like flipping a coin) of being in either group. In the music therapy group, a board-certified music therapist will sing softly with guitar accompaniment to provide music during the breathing trial. The music is in addition to the usual treatment provided by hospital staff. Participants in the standard medical care group will receive the usual medical care given by hospital staff members. Information will be collected from participant's charts and by observation of vital signs during the breathing trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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
- Patients who have had any prior SBTs
- Patients known to have a neurological injury
- Patients who are known to be deaf
- Patients whom (or whose LAR) are unable or unwilling to give informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care Standard care during an SBT Standard hospital care during an SBT. Music Therapy plus Standard Care Music therapy plus standard care during an SBT Music therapy intervention in addition to standard hospital care during an SBT.
- Primary Outcome Measures
Name Time Method Proportion of successful initial spontaneous breathing trials (SBTs) vs failed initial SBTs Up to 48 hours after the participant's initial SBT. A successful SBT is defined as when a patient sustains at least 30 minutes without mechanical ventilator support, as deemed by the respiratory therapist in the participant's chart.
A failed SBT is defined as when a patient requires mechanical ventilator support within 30 minutes of the start of the SBT, as deemed by the respiratory therapist.
- Secondary Outcome Measures
Name Time Method Mean minutes sustained off ventilator support for failed SBTs Up to 48 hours after the participant's initial SBT. Total minutes sustained off ventilator support, as noted by respiratory therapist in the participant's chart.
Mean score of blood pressure at points throughout SBT At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT Recording of patient's blood pressure via observation of monitor at three points throughout the SBT
Mean score of heart rate at points throughout SBT At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT Recording of patient's heart rate via observation of monitor at three points throughout the SBT
Mean score of respiratory rate at points throughout SBT At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT Recording of patient's respiratory rate via observation of monitor at three points throughout the SBT
Mean score of agitation as assessed by the Richmond Agitation-Sedation Scale at points throughout SBT At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT * 4 Combative- Overtly combative, violent, immediate danger to staff
* 3 Very agitated- Pulls or removes tube(s) or catheter(s); aggressive
* 2 Agitated- Frequent non-purposeful movement, fights ventilator
* 1 Restless- Anxious but movements not aggressive vigorous 0 Alert and calm
* 1 Drowsy- Not fully alert, but has sustained awakening (eye opening/contact) to voice (\>10 seconds)
* 2 Light sedation- Briefly awakens with eye contact to voice (\<10 seconds)
* 3 Moderate sedation- Movement or eye opening to voice (but no eye contact)
* 4 Deep sedation- No response to voice, but movement or eye opening to physical stimulation
* 5 Unarousable- No response to voice or physical stimulation
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States