Impact of Postanesthesia Care Unit Delirium on Postoperat... | NCT04733703

Studies
Impact of Postanesthesia Care Unit Delirium on Postoperative Quality of Recovery

NCT04733703

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Unknown status

Last Update Posted

Oct 12, 2021Actual

Enrollment

278Estimated

Phase

Not provided

Conditions

Postoperative Neurocognitive Disorders
Delirium
Postoperative Recovery
Anesthesia

Interventions

questionnaire

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2021Estimated

Primary Completion Date

Jul 2022Estimated

Completion Date

Aug 2022Estimated

First Submitted Date

Sep 28, 2020

First Submission Date that Met QC Criteria

Jan 31, 2021

First Posted Date

Feb 2, 2021Actual

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

Oct 11, 2021

Last Update Posted Date

Oct 12, 2021Actual

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

Postanesthesia care unit (PACU) delirium is subtype of postoperative delirium that occurs early after anesthesia and surgery during the recovery period. The consequences of PACU delirium have not been investigated thoroughly. So far it is unknown, whether patients with PACU delirium experience impaired postoperative quality of recovery.

The aim of this observational study is to assess the impact of PACU delirium on quality of recovery 24 hours after general anesthesia for elective non-cardiac surgery.

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

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

278Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other	assessment of postoperative quality of recovery with the QoR-15

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative quality of recovery	patient-reported quality of recovery after surgery and anesthesia with the QoR-15, ranging from 0 (poor recovery) to 150 (excellent recovery)	24 hours postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective non-cardiac surgery
general anesthesia
fluency in German

Exclusion Criteria:

expected postoperative ICU stay

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 who are scheduled for elective non-cardiac surgery and who will receive general anesthesia, are eligible for study participation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marlene Fischer, MD, PhD	Contact	+4915222827500		mar.fischer@uke.de
Christian Zöllner, MD, Prof	Contact	+4940741052415		c.zoellner@uke.de

Overall Officials

Name	Affiliation	Role
Marlene Fischer, MD, PhD	Department of Anesthesiology, University Medical Center Hamburg-Eppendorf	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
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
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided