AnaConDa Long Term Sedation Study (VALTS)

May 31, 2021 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital, University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
atmospheric volatile concentration
Time Frame: daily
Daily assessment of atmospheric volatile levels will be measured using photometric multigas infrared analyzer
daily
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
daily
Feasibility
Time Frame: 2 years
assess rate of patient recruitment and barriers to recruitment
2 years
Education Tool
Time Frame: 2 years
multidisciplinary feedback regarding teaching package, protocol, quality of sedation
2 years
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.
every 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Angela Jerath, MD, Toronto General Hospital, University Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

July 2, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimate)

November 14, 2013

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 31, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN 13-5845

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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