Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol.

NCT ID: NCT00675363

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-10-17

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.

Detailed Description

All critically ill, mechanically ventilated patients in the Intensive Care Unit receive medications to relieve pain and anxiety. However, accumulation of these medications can be associated with serious complications, most notably longer time on the breathing machine and in the ICU. Two strategies have been shown to dramatically improve patient outcomes: nurse-directed protocols for giving sedation, and daily interruption of sedation. However, these strategies have not been widely adopted, because of physicians' concerns, and because it is unclear which strategy is better. Given that patient outcome is improved with either of these strategies, the fundamental question that arises is whether patients managed with a combination of two strategies which both reduce drug accumulation (protocolized sedation and daily interruption) have an even better outcome than patients managed with only one of them (protocolized sedation).We are conducting a multicenter randomized trial in which 400 critically ill, mechanically ventilated patients will have their sedation managed with protocolized sedation alone, or both strategies. Primary outcomes are duration of mechanical ventilation and ICU and hospital lengths of stay. Secondary outcomes are the incidence of delirium, the use of neurologic tests, nurse and respiratory therapist effort associated with the sedation management, the incidence of patient self-removal of lines and tubes, and patient recall of the ICU stay. The results of this large multi-center trial will help to inform best practice with regard to sedation management of critically ill patients in Canada and elsewhere.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PS

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

Group Type: ACTIVE_COMPARATOR

Protocolized Sedation

Intervention Type: PROCEDURE

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

PS + DI

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

Group Type: ACTIVE_COMPARATOR

Protocolized sedation, with daily interruption

Intervention Type: PROCEDURE

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

Interventions

Protocolized Sedation

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

Intervention Type: PROCEDURE

Protocolized sedation, with daily interruption

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 18 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Sangeeta Mehta

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sangeeta Mehta, M.D.

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Long Beach Memorial Medical Center

Long Beach, California, United States

Tuft's Medical Centre

Boston, Massachusetts, United States

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Walter C. Mackenzie Health Sciences Centre

Edmonton, Alberta, Canada

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Surrey Memorial Hospital

Vancouver, British Columbia, Canada

Providence Health Care-St. Paul's Hospital

Vancouver, British Columbia, Canada

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

St. Joesph's Healthcare

Hamilton, Ontario, Canada

Sunnybrook HSC

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Maisonneuve Rosemount

Montreal, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 27480314 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26489482 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26181221 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25466317 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23180503 (View on PubMed)

Other Identifiers

85487

Identifier Type: -

Identifier Source: org_study_id