Feasibility of Live, Receptive Music Therapy for Patients Undergoing Spontaneous Breathing Trials: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Proportion of successful initial spontaneous breathing trials (SBTs) vs failed initial SBTs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Proportion of successful initial spontaneous breathing trials (SBTs) vs failed initial SBTs
时间窗: 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.
次要结局
- Mean minutes sustained off ventilator support for failed SBTs(Up to 48 hours after the participant's initial SBT.)
- 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)
- 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)
- 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)
- 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)