Early PONV - a Registry Based Study in Sweden.

NCT ID: NCT04433676

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1500000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is an registry study based on data from the Swedish Perioperative Registry (SPOR) during the years 2016-2022 with the aim to explore the risk for postoperative nausea and vomiting at the recovery unit (early PONV). The study will explore several cohorts (for example a specific procedure) on a national basis, report the risk for early PONV and identify associated factors.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is a registry study based on data from the Swedish Perioperative Registry (SPOR) during the years 2016-2022 with the aim to explore the risk for postoperative nausea and vomiting at the recovery unit (early PONV).

Almost all hospitals in Sweden report surgical procedures to SPOR and for the years 2016-2019 there are almost 1.7 million procedures in the registry for patients \>18years. Data will be extracted from SPOR on a yearly basis and results will be reported on selected cohorts (time periods and/or type of surgical procedure) during the study period.

There is an option for hospitals to register nausea and vomiting occurring at the recovery unit and submit the data to SPOR. If a hospital choose to use the variable in their dataset, all patients at their unit needs to be registered either with \[No\_Nausea or Vomiting\], \[Nausea\] or \[Nausea or Vomiting\]. In the year 2019, more than 50% of procedures under anesthesia in the registry had registration of PONV. The strength with this system is that if a unit uses the variable, all cases will be classified either as "noPONV" or "PONV".

The investigators aim to use the variable PONV at the recovery unit to describe the risk for early PONV and explore associated factors in several cohorts of surgical procedures in Sweden.

The first dataset (2016-2018) was sent to the investigators from the SPOR registry in May 2019 and during the period June 2019- May 2020, the dataset was used to build up a model for the analysis of data with a preliminary report of elective surgeries in Sweden the year 2017.

An updated dataset (all cases 2016-2019) was retrieved from SPOR on June 3 2020 and further analysis and reporting is based on the most updated dataset (yearly basis).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Nausea and Vomiting Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with surgical procedures

Adult patients undergoing surgical procedures under general or regional anesthesia and with an admission to a recovery unit for the initial postoperative care.

no intervention

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Procedure under general or regional anaesthesia
* Age \>=18 years at the day of the procedure.

Exclusion Criteria

* No entry of the PONV-variable in the SPOR-registry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Umeå University

OTHER

Sponsor Role collaborator

Jakob Wallden

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jakob Wallden

Senior Lecturer, Consultant Anesthesiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jakob Wallden, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Region Västernorrland (Västernorrland County Council)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Västernorrland County Council / Sundsvall Hospital

Sundsvall, X, Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jakob Wallden, MD PhD

Role: CONTACT

0046703644392

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jakob Wallden, M.D. PhD.

Role: primary

+46703644392

Antonio Moraitis, M.D. Ph.D.

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SPOR-PONV 1.0

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.