NCT00675363

Brief Summary

The purpose of this study is to determine whether the use of both a nurse-driven sedation protocol and daily sedative interruption, compared with a sedation protocol alone, result in better outcomes for mechanically ventilated adults.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
2 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2012

Completed
Last Updated

May 9, 2025

Status Verified

March 1, 2018

Enrollment Period

3.6 years

First QC Date

May 7, 2008

Last Update Submit

May 6, 2025

Conditions

Critical Illness

Keywords

ICUSedation strategiesDaily sedative interruptionSedation protocolsMechanical VentilationSedation

Outcome Measures

Primary Outcomes (1)

  • time to successful extubation

    This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.

Secondary Outcomes (1)

  • ICU and hospital lengths of stay, ICU and hospital mortality, Adverse events (e.g., self -removal of endotracheal tube)

    This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.

Study Arms (2)

PS

ACTIVE COMPARATOR

Nurse-directed protocols for administering sedation and/or analgesia by continuous infusion.

Procedure: Protocolized Sedation

PS + DI

ACTIVE COMPARATOR

Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia

Procedure: Protocolized sedation, with daily interruption

Interventions

Protocolized SedationPROCEDURE

Nurse-directed protocol for administering sedation and/or analgesia.

PS
Protocolized sedation, with daily interruptionPROCEDURE

Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia

PS + DI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or over
  • Mechanically ventilated, with anticipated need for MV ≥48 hrs
  • ICU team has decided to initiate continuous sedative/analgesic infusion(s)
  • informed consent from patient and/or SDM

You may not qualify if:

  • Admission after resuscitation from cardiac arrest
  • Traumatic brain injury
  • Currently receiving neuromuscular blocking agents
  • Allergy to midazolam and lorazepam
  • Lack of commitment to aggressive treatment
  • Previous enrolment in SLEAP, or current enrolment in related trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Long Beach Memorial Medical Center

Long Beach, California, United States

Location

Tuft's Medical Centre

Boston, Massachusetts, United States

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Walter C. Mackenzie Health Sciences Centre

Edmonton, Alberta, T6G 2B7, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Surrey Memorial Hospital

Vancouver, British Columbia, V3W 1Z2, Canada

Location

Providence Health Care-St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Joesph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Sunnybrook HSC

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Maisonneuve Rosemount

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (5)

  • Mehta S, Meade M, Burry L, Mallick R, Katsios C, Fergusson D, Dodek P, Burns K, Herridge M, Devlin JW, Tanios M, Fowler R, Jacka M, Skrobik Y, Olafson K, Cook D; SLEAP Investigators and the Canadian Critical Care Trials Group. Variation in diurnal sedation in mechanically ventilated patients who are managed with a sedation protocol alone or a sedation protocol and daily interruption. Crit Care. 2016 Aug 1;20(1):233. doi: 10.1186/s13054-016-1405-3.

    PMID: 27480314DERIVED

  • Rose L, Burry L, Mallick R, Luk E, Cook D, Fergusson D, Dodek P, Burns K, Granton J, Ferguson N, Devlin JW, Steinberg M, Keenan S, Reynolds S, Tanios M, Fowler RA, Jacka M, Olafson K, Skrobik Y, Mehta S. Prevalence, risk factors, and outcomes associated with physical restraint use in mechanically ventilated adults. J Crit Care. 2016 Feb;31(1):31-5. doi: 10.1016/j.jcrc.2015.09.011. Epub 2015 Sep 25.

    PMID: 26489482DERIVED

  • Burry L, Cook D, Herridge M, Devlin JW, Fergusson D, Meade M, Steinberg M, Skrobik Y, Olafson K, Burns K, Dodek P, Granton J, Ferguson N, Jacka M, Tanios M, Fowler R, Reynolds S, Keenan S, Mallick R, Mehta S; SLEAP Investigators; Canadian Critical Care Trials Group. Recall of ICU Stay in Patients Managed With a Sedation Protocol or a Sedation Protocol With Daily Interruption. Crit Care Med. 2015 Oct;43(10):2180-90. doi: 10.1097/CCM.0000000000001196.

    PMID: 26181221DERIVED

  • Rose L, Fitzgerald E, Cook D, Kim S, Steinberg M, Devlin JW, Ashley BJ, Dodek P, Smith O, Poretta K, Lee Y, Burns K, Harvey J, Skrobik Y, Fergusson D, Meade M, Kraguljac A, Burry L, Mehta S; SLEAP Investigators; Canadian Critical Care Trials Group. Clinician perspectives on protocols designed to minimize sedation. J Crit Care. 2015 Apr;30(2):348-52. doi: 10.1016/j.jcrc.2014.10.021. Epub 2014 Oct 30.

    PMID: 25466317DERIVED

  • Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hebert P, Sabri E, Meade M; SLEAP Investigators; Canadian Critical Care Trials Group. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA. 2012 Nov 21;308(19):1985-92. doi: 10.1001/jama.2012.13872.

    PMID: 23180503DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sangeeta Mehta, M.D.

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 9, 2008

Study Start

January 1, 2008

Primary Completion

August 1, 2011

Study Completion

October 17, 2012

Last Updated

May 9, 2025

Record last verified: 2018-03

Locations

CA(14)US(2)