AnaConDa Long Term Sedation Study

Not Applicable

Completed

• Conditions: Intubated Requiring Sedation for Greater Than 48 Hours
• Interventions: Drug: Propofol/midazolam; Drug: Isoflurane

• Registration Number: NCT01983800
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-14
• Primary Completion: 2018-02
• Status Verified: 2020-05
• Study Completion: 2020-11
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous propofol/midazolam	Propofol/midazolam	Sedation using intravenous propofol/midazolam, sedation will be titrated to a Riker Agitation Sedation Score
isoflurane	Isoflurane	Sedation using inhaled isoflurane, sedation will be titrated to a Riker Agitation Sedation Score

Primary Outcome Measures

Name	Time	Method
atmospheric volatile concentration	daily	Daily assessment of atmospheric volatile levels will be measured using photometric multigas infrared analyzer
Sedation	daily	adherence to the volatile sedation, sedation will be guided by explicit protocols targeting a Sedation-Agitation Score (SAS) of 3-4
Feasibility	2 years	assess rate of patient recruitment and barriers to recruitment
Education Tool	2 years	multidisciplinary feedback regarding teaching package, protocol, quality of sedation
serum fluoride levels	every 2 days	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.

Trial Locations

Locations (2)

Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Toronto General Hospital, University Health Network; 🇨🇦 Toronto, Ontario, Canada