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Quality Improving Program on Agitation in the Surgical Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT02199262
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Pr. Bara RICOU, University Hospital, Geneva

Brief Summary:

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)


Condition or disease Intervention/treatment Phase
Agitation Other: music intervention Other: reflexology Other: reminder Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Quality Improving Program on Agitation in the Surgical Intensive Care Unit
Study Start Date : February 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Arm Intervention/treatment
Experimental: control groupe
agitation diagnosis and management according to implemented guidelines= reminder implementation
Other: reminder
Implementation of a reminder of guidelines of agitation diagnosis and management

Experimental: music intervention + reminder
agitation diagnosis and management according to implemented guidelines+ music intervention
Other: music intervention
reminder+ 20 minutes in the morning and 20 minutes in the afternoon of music listening(classical or soft background music), delivered by compact disc players with headphones with disposable ear pads.

Experimental: reflexology + reminder
agitation diagnosis and management according to implemented guidelines + reflexology
Other: reflexology
reminder + 20 minutes per day feet reflexology massage provided by certified specialist in reflexology massages




Primary Outcome Measures :
  1. Diminution of agitation (SAS and CAM-ICU) trough a music intervention or reflexology [ Time Frame: 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).



Secondary Outcome Measures :
  1. Correlation between the reduction of the number of agitation episodes (SAS and CAM-ICU) and the number of harmful consequences [ Time Frame: lenght of patients' stay, 3.5 days on average ]
    1. Complications : Investigators will register the events related to an agitation episode or delirium and classify them in three groups 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 (sedatives, analgesics, antipsychotics).
    3. The use of contention methods will be registered will be compared for each phase of the study.


Other Outcome Measures:
  1. Effect of reminder of guidelines of agitation diagnosis (by SAS and CAM-ICU ) and management [ Time Frame: lenght of patients' stay, 3.5 days on average ]

    The caregiver 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 committee. 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 caregiver and display posters of the reminder in key points. The reminder will also be available on the intranet site and introduced in the SISIF system (bedside computerized patient chart).

    Measurement: At each agitation episode, the physician in charge of the patient will be asked the etiology of the agitation. The treatment chosen according to this diagnosis will be compared to the treatment proposed in the reminder. The percentage of treatment conforming to the reminder will be considered as the adherence to the reminder.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • older than 18 years
  • admission in ICU >24 hours

Exclusion Criteria:

  • amputation
  • paraplegia
  • non french speaking
  • consent refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199262


Locations
Switzerland
Surgical Intensive Care Unit
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva

Responsible Party: Pr. Bara RICOU, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02199262     History of Changes
Other Study ID Numbers: CER:02-190
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by Pr. Bara RICOU, University Hospital, Geneva:
Intensive care unit
Incidents
prevention
music
reflexology

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms