Quality Improving Program on Agitation in the Surgical Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,107
- 试验地点
- 1
- 主要终点
- Diminution of agitation (SAS and CAM-ICU) trough a music intervention or reflexology
研究概览
简要总结
Agitation in the intensive care unit can have multiple consequences. The investigators hypothesize that agitation and its consequences can be reduced by the introduction of a reminder aiming at guiding the management of agitation. The investigators also hypothesize that they can prevent agitation and its consequences by acting on patients environment with reafferentation and relaxation methods.
The investigators' objectives are to test within a quality improvement project by a prospective randomized study:
- If by reducing the number of agitation episodes we reduce the number of harmful consequences.
- If the introduction of reafferentation and relaxation methods (music therapy or reflexology) can prevent the occurrence of agitation.
- If the introduction of a reminder on management of agitation can reduce the number of agitation episodes.
This study is conducted in an18 general surgical ICU beds receiving 1600 patients / year for a total of 6900 hospital /days /year, in a tertiary teaching hospital.
The study is organized in 3 phases:
- First phase: Baseline phase (Prospective analysis of the present situation)
- Second phase: Learning phase (Implementation of a reminder about the management of agitation and delirium )
- Third phase: Randomized Intervention (reminder alone vs addition of music or reflexology)
The interventions are :
- Implementation of a reminder of guidelines of agitation diagnosis and management.
- Music intervention( see description below) + reminder
- Reflexology (see description below)+ reminder
Agitation is monitored with two scales SAS and CAM-ICU(description below) . Harmful consequences and complications are systematically registered as well as medication and the use of contention methods.
Adherence to the implemented monitoring and interventions is also regularly checked.
Data are daily collected (see details below) Statistical analysis and power calculation (see below)
详细描述
Agitation in the intensive care unit (ICU) can be described as an excessive, usually no purposeful motor activity associated with internal tension.Agitation can have multiple consequences.
The occurrence of agitation episodes is a problem recognized for several years and already widely discussed in the literature.
Delirium is a reversible, global impairment of cognitive processes, usually of sudden onset, coupled with disorientation, impaired short term memory, altered sensory perception (hallucinations), abnormal thought process, and inappropriate behavior.
The analysis of the literature and a previous pilot study in the unit brought us to the consideration that a quality assessment and improvement project should be started aiming at monitoring and influencing the occurrence of agitation and their consequences such as the morbidity and mortality of the patients, the impact on care delivery and maybe the economic repercussions.
Investigators hypothesized that agitation and its consequences can be reduced by the introduction of a reminder aiming at guiding the management of agitation. While the optimization of the management of the related states (such as delirium, pain and anxiety) is crucial, investigators hypothesized that we could prevent agitation and its consequences by acting on patients environment with reafferentation and relaxation methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •older than 18 years
- •admission in ICU >24 hours
排除标准
- •amputation
- •paraplegia
- •non french speaking
- •consent refusal
研究组 & 干预措施
control groupe
agitation diagnosis and management according to implemented guidelines= reminder implementation
干预措施: reminder (Other)
music intervention + reminder
agitation diagnosis and management according to implemented guidelines+ music intervention
干预措施: music intervention (Other)
reflexology + reminder
agitation diagnosis and management according to implemented guidelines + reflexology
干预措施: reflexology (Other)
结局指标
主要结局
Diminution of agitation (SAS and CAM-ICU) trough a music intervention or reflexology
时间窗: lenght of patients' stay, 3.5 days on average
Music intervention: The patient will listen to a variety of music for at least 20 minutes in the morning and in the afternoon (compact disc players with headphones with disposable ear pads). The preferred music will be freely available for the rest of the day. The choice of the music type will depend on the patients ability to communicate his desires. If the patient is not able to express his choice, the caregiver will ask his next of kin. If the information is not available, the caregiver will select a type of music he judges adapted to the patient's situation. Reflexology: This therapy will be applied 20 minutes per day to patients by a certified specialist in reflexologic massages. Measurements : Investigators analyze the presence or absence of agitation and delirium by SAS and CAM-ICU at each evaluation judged necessary by the nurse, at least once by shift (every 8 hours).
次要结局
- Correlation between the reduction of the number of agitation episodes (SAS and CAM-ICU) and the number of harmful consequences(lenght of patients' stay, 3.5 days on average)
研究者
Pr. Bara RICOU
Professor
University Hospital, Geneva