Patient-reported Outcome Measures After Post-anesthesia C... | NCT04168268

Studies
Patient-reported Outcome Measures After Post-anesthesia Care Unit Delirium

NCT04168268

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Last Update Posted

Nov 19, 2019Actual

Enrollment

222Actual

Phase

Not provided

Conditions

Delirium
Neurocognitive Disorders

Interventions

Not provided

Countries

Germany

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

Nov 2019

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

Nov 28, 2017Actual

Primary Completion Date

Dec 11, 2018Actual

Completion Date

Dec 11, 2018Actual

First Submitted Date

Nov 16, 2019

First Submission Date that Met QC Criteria

Nov 16, 2019

First Posted Date

Nov 19, 2019Actual

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

Nov 16, 2019

Last Update Posted Date

Nov 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 self-reported cognitive function and health-related quality of life in patients with and without early postoperative delirium

Detailed Description

Neurocognitive disorders including postoperative delirium are a serious complication after surgery and anesthesia in the elderly. Postoperative delirium is an acute-onset diffuse brain dysfunction that is characterized by a fluctuating course of confusion, disorganized thinking, inattention, irritability, disturbances of the circadian rhythm, and disorders of consciousness. Post-anesthesia care unit (PACU) delirium occurs immediately after emergence from anesthesia and affects up to 45% of patients after elective surgery.

It is unclear, whether PACU delirium is associated with intermediated or long-term adverse outcomes including neurocognitive disorders or mortality. The aim of this prospective observational was to assess self-reported cognitive function and health-related quality of life in patients with and without PACU delirium three months after radical prostatectomy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

222Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-reported cognitive failures	Cognitive Failures Questionnaire	three months

Secondary Outcomes

Measure	Description	Time Frame
Health-related quality of life	Short Form Health Survey 36	three months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective radical prostatectomy
>60 years
fluent in German

Exclusion Criteria:

preexisting cognitive impairment
cerebrovascular disease

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for elective radical prostatectomy for prostate cancer at a high-volume prostate cancer center were screened on the day before surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, University Medical Center Hamburg-Eppendorf		Hamburg		20246	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35084649	Derived	Kainz E, Stuff K, Kahl U, Wiessner C, Yu Y, von Breunig F, Nitzschke R, Haese A, Graefen M, Fischer M. Impact of postanesthesia care unit delirium on self-reported cognitive function and perceived health status: a prospective observational cohort study. Qual Life Res. 2022 Aug;31(8):2397-2410. doi: 10.1007/s11136-022-03087-1. Epub 2022 Jan 27.

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

ID	Term
D003693	Delirium
D019965	Neurocognitive Disorders