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Critical Illness | Development and Evaluation of Strategies to Improve Sedation Quality in InTensive Care

Critical Illness research study

What is the primary objective of this study?

Who is eligible to participate?

Inclusion Criteria: 1. All patients admitted to ICU mechanically ventilated and intubated. 2. All patients in whom mechanical ventilation via an endotracheal tube is instituted at some time after ICU admission will also be eligible for inclusion from the time intubation and mechanical ventilation begins. Exclusion Criteria: 1. Patients who are not receiving mechanical ventilation via an endotracheal tube 2. Patients who received mechanical ventilation following ICU admission but this has been discontinued at the time of screening for study inclusion 3. Patients in whom discontinuation of mechanical ventilation is anticipated in the next 4 hours 4. Patients in whom a decision to withdraw active therapy has been made 5. Patients who have already been enrolled in the during the same hospital admission 6. Patients whom have been mechanically ventilated and intubated for greater than 24 hrs by the time relatives are approached for consent

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Critical Illness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Bespoke on-line sedation education packageA bespoke on-line education package has been developed and will be accessible by all ICU nursing staff. They will have unique logins and the system will track their use and completion of the education package. There is a small multiple choice assessment at the end of the package.

Other:Sedation specific outcome process feedbackUsing statistical process charts, the data gathered from the Sedation quality Tools (SQATs) completed each shift by the ICU nurses, will be fed back highlighting sedation specific outcomes e.g. number of over sedated days per 1000 ventilator days.

Device:Responsiveness monitoring; novel sedation monitorResponsiveness monitoring (developed by GE Healthcare) is a novel technology used to monitor patient responsiveness and essentially alert ICU nursing staff when their patients may be over sedated.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Education Package2 ICUs; one large and one small. Randomised to receive bespoke education package for the 9 month intervention period

Education and Feedback2 ICUs; one large and one small. Randomised to receive a bespoke education package and real-time,site specific, outcome process feedback they will disseminate to their staff for the 9 month intervention period.

Education and Sedation Monitoring2 ICUs; one large and one small. Randomised to receive a bespoke education package and a new novel sedation (responsiveness) monitor for the 9 month intervention period.

Education, Feedback, Sedation Monitoring2 ICUs; one large and one small. Randomised to receive a bespoke education package, real-time,site specific, outcome process feedback they will disseminate to their staff and a new novel sedation (responsiveness) monitor for the 9 month intervention period.

Study Status

Completed

Start Date: June 2012

Completed Date: December 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change from baseline the effect of individual and combinations of the interventions named on achievement of optimal sedation practice

Secondary Outcome: Number of ventilation days

Study sponsors, principal investigator, and references

Principal Investigator: Timothy S Walsh, MD

Lead Sponsor: University of Edinburgh

Collaborator: Chief Scientist Office of the Scottish Government

More information:https://clinicaltrials.gov/show/NCT01634451

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