Delirium in Mechanically Ventilated Patients | NCT00919698

Studies
Delirium in Mechanically Ventilated Patients

NCT00919698

Sponsor

University of Chicago

Status

Completed

Last Update Posted

Dec 3, 2014Estimated

Enrollment

102Actual

Phase

Not provided

Conditions

Delirium

Interventions

Not provided

Countries

United States

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

Dec 2014

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

Jun 2010

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jun 10, 2009

First Submission Date that Met QC Criteria

Jun 10, 2009

First Posted Date

Jun 12, 2009Estimated

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

Dec 2, 2014

Last Update Posted Date

Dec 3, 2014Estimated

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

The overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the ICU.

Detailed Description

This is a single center, observational, cross-over design study assessing the impact of daily awakening from sedation on delirium in the ICU. Enrolled patients will receive a daily baseline delirium assessment using the CAM-ICU tool before the awakening from sedation and an assessment during the awakening from sedation. Each patient will thus serve as their own controls for these interventions.

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

102Actual

Label	Type	Description	Intervention Names
Sedated mechanically ventilated patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Delirium		Daily

Secondary Outcomes

Measure	Description	Time Frame
ICU admitting diagnosis		At enrollment
Medications		Daily
Ventilator free days (or first 28)

Other Outcomes

Measure	Description	Time Frame
survival		1 year
institution free days		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years old
intubated and mechanically ventilated
receiving sedative and/or analgesic medication
candidate for daily awakening from sedative and/or analgesic medication

Exclusion Criteria:

primary neurologic disease (stroke, seizure, elevated ICP)
post cardiac arrest
do not speak English (assessment only English language validated)

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

Adult patients (> 18 years old) admitted to the intensive care unit who require mechanical ventilation through an endotracheal tube with infusion of sedative or analgesic medication.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John P Kress, MD	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Chicago		Chicago	Illinois	60637	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24423152	Derived	Patel SB, Poston JT, Pohlman A, Hall JB, Kress JP. Rapidly reversible, sedation-related delirium versus persistent delirium in the intensive care unit. Am J Respir Crit Care Med. 2014 Mar 15;189(6):658-65. doi: 10.1164/rccm.201310-1815OC.

ID	Term
D003693	Delirium
D053120	Respiratory Aspiration

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases