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AnaConDa Long Term Sedation Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01983800
Acronym
VALTS
Enrollment
60
Registered
2013-11-14
Start date
2013-07-31
Completion date
2020-11-30
Last updated
2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubated Requiring Sedation for Greater Than 48 Hours

Keywords

Mechanical Ventilation, Volatile Sedation, Intravenous Sedation, Delirium

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.

Interventions

DRUGIsoflurane
DRUGPropofol/midazolam

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
atmospheric volatile concentrationdailyDaily assessment of atmospheric volatile levels will be measured using photometric multigas infrared analyzer
Sedationdailyadherence to the volatile sedation, sedation will be guided by explicit protocols targeting a Sedation-Agitation Score (SAS) of 3-4
Feasibility2 yearsassess rate of patient recruitment and barriers to recruitment
Education Tool2 yearsmultidisciplinary feedback regarding teaching package, protocol, quality of sedation
serum fluoride levelsevery 2 daysMeasurements will be taken 24 hours post sedation and every 2 days until while on sedation followed by 2 further samples after discontinuation of sedation.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026