NCT00675363

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

A Randomized Trial of Daily Sedative Interruption in Critically Ill, Mechanically Ventilated Patients Being Managed With a Sedation Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Protocolized Sedation	Nurse-directed protocol for administering sedation and/or analgesia.
PROCEDURE	Protocolized sedation, with daily interruption	Nurse-directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-08-01
• Completion: 2012-10-17
• First posted: 2008-05-09
• Last updated: 2025-05-09

Locations

16 sites across 2 countries: United States, Canada