Improved ICU Outcomes With Protocolized Management of Ana... | NCT00506649

Studies
Improved ICU Outcomes With Protocolized Management of Analgesia, Sedation and Delirium

NCT00506649

Sponsor

Maisonneuve-Rosemont Hospital

Status

Completed

Last Update Posted

Jul 25, 2007Estimated

Enrollment

1,214Actual

Phase

Not provided

Conditions

Critical Care

Interventions

protocol

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Not provided

Completion Date

Nov 2005Actual

First Submitted Date

Jul 23, 2007

First Submission Date that Met QC Criteria

Jul 23, 2007

First Posted Date

Jul 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2007

Last Update Posted Date

Jul 25, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess pain, agitation, and delirium experienced by critically ill patients daily and evaluate the impact of a protocol; to compare the incidence of coma and delirium, length of stay, mortality and costs of care between pre- and post-protocol groups.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,214Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
protocol	Other	management protocols of non-pharmacological strategies and individualized titration of analgesics, sedatives, and anti-psychotics based on observed scores to manage sedation, analgesia and delirium.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients admitted to ICU

Exclusion Criteria:

Repeat admission within the same hospitalisation; moribund patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yoanna Skrobik, MD FRCP(c)	Maisonneuve-Rosemont Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Maisonneuve Rosemont		Montreal	Quebec	H1T 2M4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia
D003693	Delirium
D003128	Coma

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002985	Clinical Protocols

Ancestor Terms

ID	Term
D013812	Therapeutics
D016020	Epidemiologic Study Characteristics
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided