AnaConDa Long Term Sedation Study

Intubated Requiring Sedation for Greater Than 48 Hours Clinical Trial

— VALTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983800
• Other study ID #: UHN 13-5845
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: November 2020

Study information

• Verified date: May 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2020
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intubated Requiring Sedation for Greater Than 48 Hours

Intervention

Drug:
• Isoflurane

• Propofol/midazolam

Locations

Country	Name	City	State
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	atmospheric volatile concentration	Daily assessment of atmospheric volatile levels will be measured using photometric multigas infrared analyzer	daily
Primary	Sedation	adherence to the volatile sedation, sedation will be guided by explicit protocols targeting a Sedation-Agitation Score (SAS) of 3-4	daily
Primary	Feasibility	assess rate of patient recruitment and barriers to recruitment	2 years
Primary	Education Tool	multidisciplinary feedback regarding teaching package, protocol, quality of sedation	2 years
Primary	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