Intubated Requiring Sedation for Greater Than 48 HoursVALTSNCT01983800
AnaConDa Long Term Sedation Study
A study testing Isoflurane and Propofol/midazolam in people with Intubated Requiring Sedation for Greater Than 48 Hours, run by University Health Network, Toronto at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubated Requiring Sedation for Greater Than 48 Hours
- What is being tested?
- Isoflurane and Propofol/midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2013to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult ICU patients expected to be ventilated > 48 hours
Who cannot join
- 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
Show all 10Show fewer
- pregnant
- NebulizedFlolan
- tidal volume <350ml
- patients on one lung ventilation
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: 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.
- Being tested
- Isoflurane, Propofol/midazolam
- Keywords
- Mechanical Ventilation, Volatile Sedation, Intravenous Sedation, Delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsofluraneDrug
Propofol/midazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| intravenous propofol/midazolam | Active comparator | Sedation using intravenous propofol/midazolam, sedation will be titrated to a Riker Agitation Sedation Score Receives: Drug: Propofol/midazolam |
| isoflurane | Active comparator | Sedation using inhaled isoflurane, sedation will be titrated to a Riker Agitation Sedation Score Receives: Drug: Isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
atmospheric volatile concentration
Daily assessment of atmospheric volatile levels will be measured using photometric multigas infrared analyzer
Measured: daily
Sedation
adherence to the volatile sedation, sedation will be guided by explicit protocols targeting a Sedation-Agitation Score (SAS) of 3-4
Measured: daily
Feasibility
assess rate of patient recruitment and barriers to recruitment
Measured: 2 years
Education Tool
multidisciplinary feedback regarding teaching package, protocol, quality of sedation
Measured: 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.
Measured: every 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2018
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubated Requiring Sedation for Greater Than 48 HoursStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Jerath, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983800
- Sponsor's protocol ID
- UHN 13-5845
- Acronym
- VALTS
- Status last verified
- May 2020
- First submitted
- 2 Jul 2013
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26646404
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Volatile Anesthetics for Long-Term Sedation In Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01983800
- Acronym / sponsor ID
- VALTS / UHN 13-5845
- Keywords
- Mechanical Ventilation, Volatile Sedation, Intravenous Sedation, Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous propofol/midazolam | Active comparator | Drug: Propofol/midazolamSedation using intravenous propofol/midazolam, sedation will be titrated to a Riker Agitation Sedation Score |
| isoflurane | Active comparator | Drug: IsofluraneSedation using inhaled isoflurane, sedation will be titrated to a Riker Agitation Sedation Score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult ICU patients expected to be ventilated > 48 hours
Key exclusion criteria (10 listed)
- age < 18 years
- history of malignant hyperthermia
- propofol infusion syndrome
- evidence of raised intracranial pressure
- 6-month mortality risk from pre-existing condition > 50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isoflurane | Drug | isoflurane |
| Propofol/midazolam | Drug | intravenous propofol/midazolam |
Primary outcome
atmospheric volatile concentration
Time frame: daily
Daily assessment of atmospheric volatile levels will be measured using photometric multigas infrared analyzer
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
Feasibility
Time frame: 2 years
assess rate of patient recruitment and barriers to recruitment
Education Tool
Time frame: 2 years
multidisciplinary feedback regarding teaching package, protocol, quality of sedation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Derived from this study: PubMed 26646404Jerath 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Jerath, MD principal investigator
Toronto General Hospital, University Health Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoflurane and Propofol/midazolam in people with Intubated Requiring Sedation for Greater Than 48 Hours, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atmospheric volatile concentration (time frame: daily). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01983800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.