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Quality Improving Program on Agitation in the Surgical Intensive Care Unit

NCT02199262 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1107

Last updated 2014-07-24

No results posted yet for this study

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)

Conditions

  • Agitation

Interventions

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.

OTHER

reflexology

reminder + 20 minutes per day feet reflexology massage provided by certified specialist in reflexology massages

OTHER

reminder

Implementation of a reminder of guidelines of agitation diagnosis and management

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2005-01-31
Completion
2005-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02199262 on ClinicalTrials.gov