Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of the Quality of Recovery Questionnaire for the Postanesthesia Care Unit (QoR-PACU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528537
Recruitment Status : Completed
First Posted : August 27, 2020
Last Update Posted : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
Marlene Fischer, Universitätsklinikum Hamburg-Eppendorf

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Postoperative Quality of Recovery in the Postanesthesia Care Unit Other: questionnaire

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 375 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adaptation and Validation of the Quality of Recovery 15-questionnaire for the Postanesthesia Care Unit
Actual Study Start Date : August 10, 2020
Actual Primary Completion Date : November 23, 2020
Actual Study Completion Date : December 28, 2020
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: questionnaire
    16-item quality of recovery questionnaire for the postanesthesia care unit (QoR-PACU)

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • elective non-cardiac surgery
  • general anesthesia
  • fluency in German

Exclusion Criteria:

  • postoperative intensive care unit stay
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528537


Locations
Layout table for location information
Germany
Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Marlene Fischer
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Marlene Fischer, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04528537    
Other Study ID Numbers: PACQoR3
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: October 11, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No