Daily sedative interruption in critically ill patients being managed with a sedation protocol

Not Applicable

Completed

• Conditions: Mechanical ventilation; Surgery; Ventilation

• Registration Number: ISRCTN83837813
• Lead Sponsor: Mount Sinai Hospital (Canada)

Brief Summary

2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/23180503 [added 28/02/2019] 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25466317 [added 28/02/2019] 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26181221 [added 28/02/2019] 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26489482 [added 28/02/2019] 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27480314 [added 28/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-23
• Study Completion: 2010-06-01
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

1. Aged greater than or equal to 18 years
2. Mechanically ventilated, with anticipated need for mechanical ventilation greater than or equal to 48 hours
3. ICU team has decided to initiate continuous sedative/analgesic infusion(s)
4. Informed consent

Additional SLEAP-SCP Trial inclusion criteria:
1. In an ICU at participating hospitals
2. Aged greater than or equal to 18 years old
3. Intubated and mechanically ventilated
4. Receiving infusions of sedation and/or analgesia
5. Able to speak and understand English

Exclusion Criteria

1. Admission after resuscitation from cardiac arrest
2. Traumatic brain injury
3. Currently receiving neuromuscular blocking agents (but these patients may be enrolled after these agents are discontinued)
4. Allergy to midazolam and lorazepam
5. Lack of commitment to aggressive treatment
6. Current enrolment in a related trial
7. Previous enrolment in this trial

Additional SLEAP-SCP Trial exclusion criteria:
1. Patients unable to communicate
2. Incompetent to decide on participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Time to successful extubation measured from intubation to extubation or tracheostomy mask for 48 hours.<br><br> SLEAP-SCP Trial:<br> Extent of depressive, anxiety (Hospital Anxiety And Depression Scale [HADS] scores) and PTSD symptoms (Impact of Events Scale [IES] scores), compared across the two arms of the SLEAP study.<br>