AnaConDa Long Term Sedation Study

Study Overview
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Brief Summary
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Heavy sedation or sleep is a common problem within the intensive care unit (ICU) using our standard intravenous medications. This commonly leads to confusion, low blood pressure, slow wake up and removal of the artificial breathing tube (extubation), which prolongs ICU stay. Using inhaled volatile anesthetic agents are likely to improve these patient outcomes. This unique project is the first North American study looking at using volatiles for patients who need longer-term ICU sedation. This project has excellent potential at lowering these complications and improving quality of care, which will lower patient ICU stay and healthcare costs.

Official Title
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Use of Volatile Anesthetics for Long-Term Sedation In Critically Ill Patients

Conditions
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Intubated Requiring Sedation for Greater Than 48 Hours

Intervention / Treatment
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* Drug: Isoflurane
* Drug: Propofol/midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult ICU patients expected to be ventilated > 48 hours Exclusion Criteria: age < 18 years history of malignant hyperthermia propofol infusion syndrome evidence of raised intracranial pressure 6-month mortality risk from pre-existing condition > 50% lack of commitment to maximal treatment pregnant NebulizedFlolan tidal volume <350ml patients on one lung ventilation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intravenous propofol/midazolam<br>Sedation using intravenous propofol/midazolam, sedation will be titrated to a Riker Agitation Sedation Score | Drug: Propofol/midazolam<br> <br> |
| Active Comparator: isoflurane<br>Sedation using inhaled isoflurane, sedation will be titrated to a Riker Agitation Sedation Score | Drug: Isoflurane<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atmospheric volatile concentration | Daily assessment of atmospheric volatile levels will be measured using photometric multigas infrared analyzer | daily | 
| Sedation | adherence to the volatile sedation, sedation will be guided by explicit protocols targeting a Sedation-Agitation Score (SAS) of 3-4 | daily | 
| Feasibility | assess rate of patient recruitment and barriers to recruitment | 2 years | 
| Education Tool | multidisciplinary feedback regarding teaching package, protocol, quality of sedation | 2 years | 
| serum fluoride levels | Measurements will be taken 24 hours post sedation and every 2 days until while on sedation followed by 2 further samples after discontinuation of sedation. | every 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical Ventilation, Volatile Sedation, Intravenous Sedation, Delirium