NCT01983800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2020

Enrollment Period

4.6 years

First QC Date

July 2, 2013

Last Update Submit

May 31, 2021

Conditions

Intubated Requiring Sedation for Greater Than 48 Hours

Keywords

Mechanical VentilationVolatile SedationIntravenous SedationDelirium

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

intravenous propofol/midazolam

ACTIVE COMPARATOR

Sedation using intravenous propofol/midazolam, sedation will be titrated to a Riker Agitation Sedation Score

Drug: Propofol/midazolam

isoflurane

ACTIVE COMPARATOR

Sedation using inhaled isoflurane, sedation will be titrated to a Riker Agitation Sedation Score

Drug: Isoflurane

Interventions

IsofluraneDRUG
isoflurane
Propofol/midazolamDRUG
intravenous propofol/midazolam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult ICU patients expected to be ventilated \> 48 hours

You may not qualify if:

  • age \< 18 years
  • history of malignant hyperthermia
  • propofol infusion syndrome
  • evidence of raised intracranial pressure
  • month mortality risk from pre-existing condition \> 50%
  • lack of commitment to maximal treatment
  • pregnant
  • NebulizedFlolan
  • tidal volume \<350ml
  • patients on one lung ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

  • Jerath A, Ferguson ND, Steel A, Wijeysundera D, Macdonald J, Wasowicz M. The use of volatile anesthetic agents for long-term critical care sedation (VALTS): study protocol for a pilot randomized controlled trial. Trials. 2015 Dec 9;16:560. doi: 10.1186/s13063-015-1083-5.

    PMID: 26646404DERIVED

MeSH Terms

Conditions

Delirium

Interventions

IsofluranePropofolMidazolam

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Angela Jerath, MD

    Toronto General Hospital, University Health Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2013

First Posted

November 14, 2013

Study Start

July 1, 2013

Primary Completion

February 1, 2018

Study Completion

November 1, 2020

Last Updated

June 2, 2021

Record last verified: 2020-05

Locations

CA(2)