- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528537
Validation of the Quality of Recovery Questionnaire for the Postanesthesia Care Unit (QoR-PACU)
October 8, 2021 updated by: Marlene Fischer
Adaptation and Validation of the Quality of Recovery 15-questionnaire for the Postanesthesia Care Unit
Quality of recovery after surgery and anesthesia is an important endpoint in perioperative medicine.
Several questionnaires have been developed that assess the patient's perception on postoperative recovery at 24 h after surgery.
This study aims to adapt validate the Quality of Recovery 15-questionnaire for application in the postanesthesia care unit.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
375
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hamburg, Germany, 20246
- Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for non-cardiac surgery under general anesthesia in a postanesthesia care unit at a tertiary care hospital
Description
Inclusion Criteria:
- elective non-cardiac surgery
- general anesthesia
- fluency in German
Exclusion Criteria:
- postoperative intensive care unit stay
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
16-item quality of recovery questionnaire for the postanesthesia care unit (QoR-PACU)
Time Frame: up to 4 hours following extubation
|
Validity of the QoR-PACU
|
up to 4 hours following extubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2020
Primary Completion (Actual)
November 23, 2020
Study Completion (Actual)
December 28, 2020
Study Registration Dates
First Submitted
August 24, 2020
First Submitted That Met QC Criteria
August 26, 2020
First Posted (Actual)
August 27, 2020
Study Record Updates
Last Update Posted (Actual)
October 11, 2021
Last Update Submitted That Met QC Criteria
October 8, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- PACQoR3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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