Quality Improving Program on Agitation in the Surgical Intensive Care Unit
Quality Improving Program on Agitation in the Surgical Intensive Care Unit
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:

 1. First phase: Baseline phase (Prospective analysis of the present situation)

 2. Second phase: Learning phase (Implementation of a reminder about the management of
 agitation and delirium )

 3. Third phase: Randomized Intervention (reminder alone vs addition of music or
 reflexology)

 The interventions are :

 1. Implementation of a reminder of guidelines of agitation diagnosis and management.

 2. Music intervention( see description below) + reminder

 3. 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)
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.

 The investigators' objectives will be 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.

 Setting:

 18 general surgical ICU beds receiving 1600 patients / year for a total of 6900 hospital
 /days /year, in a tertiary teaching hospital. The ICU is divided in 6 rooms with 3 beds: 1 at
 the window, 1 in the middle of the room and 1 by the room door. Each room has one clock in
 front of the central bed.

 The nurse to patient ratio is during daytime 1:1.5 and 1:2 during nighttime. Nurses working
 shifts are organized in 3 times 8 hours every day. This study has been approved by the head
 of division and will be conducted solely inside the surgical ICU. As a quality improvement
 program, no consent by patients is required, according to the CEREH /HUG recommendations.

 Patients:

 Investigators will enroll every patient older than 18 years staying more than 24 hours in the
 ICU

 1. First phase: Baseline phase (Prospective analysis of the present situation)

 2. Second phase: learning phase (Implementation of a reminder about the management of
 agitation and delirium )

 3. Third phase: Randomized Intervention (reminder alone vs addition of music or
 reflexology)

 Interventions:

 Reminder :

 The care giver will be helped in the diagnosis of the cause, the management of and the
 treatment of agitation and delirium by a reminder. This reminder has been adapted from the
 guidelines from the ACCP and SCCM comity. It has been adapted on local needs by a
 multidisciplinary group including nurses and physicians from the ICU. Investigators will
 instruct nurses and physicians on the use of the reminder 3 times a week for 20 min during 1
 month. Investigators will provide pocket reminders for every care giver and display posters
 of the reminder in key points of the ICU. The reminder will also be available on the intranet
 site and introduced in the SISIF system (bedside computerized patient chart).

 The music intervention consisted in two daily sessions of at least 20 minutes music listening
 ( classical and soft background music ) .The music intervention was delivered by compact disc
 players with headphones with disposable ear pads.

 The reflexology is a feet massage technique consisting in massages and pressures on precise
 points of the feet.This therapy was applied for 20 minutes each day to the ICU patients by a
 certified specialist in reflexology massage

 Indicators :

 Indicators of agitation:

 1.Sedation Agitation scale (SAS) and Confusion Assessment Method for ICU (CAM-ICU): The SAS
 scale is recognized for its reliability and validity for the sedation and agitation
 assessment. It is a single item scale graded from 1 (coma) to 7 (extremely agitated.
 Agitation is diagnosed if SAS >4.

 The CAM-ICU score is a modified version of the CAM scale adapted to intensive care patients.
 This scale assesses delirium (positive CAM-ICU test) by considering four different parameters
 that mostly focus on patient's cognitive state . It is also validated and recognized for its
 high specificity and sensitivity.

 Investigators will analyze the presence or absence of delirium at each evaluation judged
 necessary by the nurse, at least once by shift (every 8 hours).

 Investigators will then investigate whether 1. the positive CAM-ICU will precede the
 occurrence of agitation defined as SAS>4, 2. whether low values of SAS, <4 or >4 precede
 higher values of SAS.

 Indicators of the harmful consequences:

 1. Complications : Investigators will register the events related to an agitation episode
 or delirium and classify them in three groups. The three groups are determined by the
 potential life threatening character of the event. One event can be considered as severe
 i.e. really life threatening (self extubation, ventilator disconnection, central
 catheter removal, chest tube removal, trauma, falling from bed), moderate (removal of
 nasogastric tube, peripheral venous or arterial catheter) or mild i.e. not life
 threatening (contortion of the patient in his bed, patient's aggressiveness toward the
 staff, urethral catheter removal, electrode or saturation monitoring removal).

 2. Medication : Investigators will register the patient's medication in a daily total dose
 (mg /patient/day/drug) of 3 drug groups in relation with agitation. Investigators will
 compare the use of medication during the different study phases and between the 3
 different groups during the third phase.

 sedatives: oxazepam, lorazepam,midazolam, propofol analgesics: acetaminophen, ibuprofen,
 morphine, fentanyl, ketorolac antipsychotics: haloperidol, thioridazine

 3. The use of contention methods will be registered will be compared for each phase of the
 study.

 Indicators of adherence:

 1. Adherence to the implementation of monitoring (SAS, CAM-ICU) during the 3 phases.

 2. Adherence to the reminder

 3. Adherence to intervention (reflexology and music therapy)

 Indicators of safety:

 Investigators will assess the occurrence of adverse events potentially related to the therapy
 or management of agitation.

 1. Intubations: the study team will register the number of intubations related to
 agitation.

 2. Antagonist drugs: the study team will register the use of antagonist drugs such as
 naloxone chlorhydrate (Narcan®), flumazenil (Anexate®) and biperidene(Akineton®)
 following the treatment of agitation .

 Data collection First phase

 1. 24 hours after ICU admission, the study team will assess the demographic and actual
 diagnostic data, the past medical history, the usual and actual treatment, the current
 smoking history, alcohol and drug abuse, the invasive equipment and the APACHE II score.

 2. Daily investigators will also assess the treatment and equipment modifications, the
 laboratory values of variables potentially related to agitation (sodium, glucose,
 calcium, urea, creatinine, bilirubin, oxygen saturation, FiO2), fever, the occurrence of
 infections, the introduction of therapeutic antibiotics. The bed location in the room
 will be specified (door, middle, window). Investigators will also daily record the
 consequence (annex 7) and safety indicators . No additional test or exam will be
 performed for the purpose of the study.

 3. Three times a day (once by nurse shift) the nurses will assess agitation and delirium by
 SAS and CAM-ICU. Each time the attending nurse notices a modification of degree of
 agitation, she will register the concomitant SAS.

 4. At the end of each patient stay investigators will calculate the total dosage
 (mg/kg/day) p.o. or i.v of sedatives (benzodiazepines, propofol or others), analgesics
 (acetaminophen, NSARs, morphine, fentanyl or others) or antipsychotic drugs (haloperidol
 or others) delivered to every patient.

 Second phase In addition to all the data collected during the first phase, investigators will
 register the adherence to the reminder at each agitation episode.

 Third phase Same data as during the second phase. In addition, investigators will note daily
 the correct delivery of the allocated intervention.

 Statistical analysis and power calculation:

 Investigators will use analysis of variance (ANOVA) with Bonferroni's post-test or
 Kruskal-Wallis where appropriated. Proportions will be analyzed by Pearson's 2.

 The endpoint of the study is to reduce the occurrence of the consequences of agitation and/or
 delirium. The sample size is calculated to detect a minimum mean difference of 50% of the
 number of patient days with occurrence of the consequences of agitation and delirium. In a
 preliminary study, investigators assessed the occurrence of "consequences" in about 20% of
 patient/days.

 The number (=n) of patients needed to detect a minimum mean difference of 50% between the
 baseline and the learning phase is 219 (a 0.05, power 80% two sided), and 219 in the three
 randomization groups. 80 patients per month present the inclusion criteria for the study.
 Thus, we need 2.7 months in the Baseline, a minimum of 2.7 months in the Learning and 8.1
 months for the Randomization Intervention periods.

 All continuous variables will be expressed as mean SD (normally distributed) or medians and
 range (non normally distributed). A p value <0.05 will be considered significant.
Inclusion Criteria:

 -  older than 18 years

 -  admission in ICU >24 hours

 Exclusion Criteria:

 -  amputation

 -  paraplegia

 -  non french speaking

 -  consent refusal