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Completed

NCT Number: NCT01983800

AnaConDa Long Term Sedation Study

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.

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Key information

Conditions

Intubated Requiring Sedation for Greater Than 48 Hours Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ottawa Heart Institute, Ottawa, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isoflurane

Drug

Propofol/midazolam

Drug

Primary outcomes

  1. atmospheric volatile concentration

    Time frame: daily

    Daily assessment of atmospheric volatile levels will be measured using photometric multigas infrared analyzer

  2. Sedation

    Time frame: daily

    adherence to the volatile sedation, sedation will be guided by explicit protocols targeting a Sedation-Agitation Score (SAS) of 3-4

  3. Feasibility

    Time frame: 2 years

    assess rate of patient recruitment and barriers to recruitment

  4. Education Tool

    Time frame: 2 years

    multidisciplinary feedback regarding teaching package, protocol, quality of sedation

  5. serum fluoride levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: VALTS

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Nov 14, 2013
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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