Postoperative Quality of Recovery in the Postanesthesia Care UnitNCT04528537
Validation of the Quality of Recovery Questionnaire for the Postanesthesia Care Unit (QoR-PACU)
An observational study of Postoperative Quality of Recovery in the Postanesthesia Care Unit, run by Marlene Fischer at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Quality of Recovery in the Postanesthesia Care Unit
- What is being tested?
- questionnaire
- How many people
- 375 participants
- Where
- 1 siteGermany
- Study dates
- 10 Aug 2020to 28 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for non-cardiac surgery under general anesthesia in a postanesthesia care unit at a tertiary care hospital
Who may be able to join
- elective non-cardiac surgery
- general anesthesia
- fluency in German
Who cannot join
- postoperative intensive care unit stay
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: 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.
- Being tested
- questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
16-item quality of recovery questionnaire for the postanesthesia care unit (QoR-PACU)
What is being measured
The primary outcome is the main question the study is designed to answer.
16-item quality of recovery questionnaire for the postanesthesia care unit (QoR-PACU)
Validity of the QoR-PACU
Measured: up to 4 hours following extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start10 Aug 2020
- Primary completion23 Nov 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Quality of Recovery in the Postanesthesia Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marlene Fischer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marlene Fischer, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528537
- Sponsor's protocol ID
- PACQoR3
- Status last verified
- Oct 2021
- First submitted
- 24 Aug 2020
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Validation of the Quality of Recovery 15-questionnaire for the Postanesthesia Care Unit
- ClinicalTrials.gov ID
- NCT04528537
- Acronym / sponsor ID
- PACQoR3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Marlene FischerUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for non-cardiac surgery under general anesthesia in a postanesthesia care unit at a tertiary care hospital
Key inclusion criteria (3 listed)
- elective non-cardiac surgery
- general anesthesia
- fluency in German
Key exclusion criteria (1 listed)
- postoperative intensive care unit stay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire16-item quality of recovery questionnaire for the postanesthesia care unit (QoR-PACU) | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: No
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Quality of Recovery in the Post-anesthesia Care Unit
Postoperative Quality of Recovery, Postoperative Quality of Recovery in the Postanesthesia Care Unit
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Quality of Recovery in the Postanesthesia Care Unit, run by Marlene Fischer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16-item quality of recovery questionnaire for the postanesthesia care unit (QoR-PACU) (time frame: up to 4 hours following extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.