VALTS: AnaConDa Long Term Sedation Study

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT01983800
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Actual Duration (Months): 88
• Patients Per Site: 30
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intubated Requiring Sedation for Greater Than 48 Hours	Drug: Isoflurane; Drug: Propofol/midazolam	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Volatile Anesthetics for Long-Term Sedation In Critically Ill Patients
• Actual Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Nov 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. atmospheric volatile concentration [daily]

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

2. Sedation [daily]

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

3. Feasibility [2 years]

   assess rate of patient recruitment and barriers to recruitment

4. Education Tool [2 years]

   multidisciplinary feedback regarding teaching package, protocol, quality of sedation

5. serum fluoride levels [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y 4W7
2	Toronto General Hospital, University Health Network	Toronto	Ontario	Canada	M5G 2C4

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT01983800
• Other Study ID Numbers: UHN 13-5845
• First Posted: Nov 14, 2013
• Last Update Posted: Jun 2, 2021
• Last Verified: May 1, 2020

• Keywords provided by University Health Network, Toronto: Mechanical Ventilation; Volatile Sedation; Intravenous Sedation; Delirium
• Additional relevant MeSH terms: Midazolam; Propofol; Isoflurane

Study Results

No Results Posted as of Jun 2, 2021