Early PONV - a Registry Based Study in Sweden.

Postoperative Complications Clinical Trial

— SPOR-PONV  

Official title:

Risk of Early Postoperative Nausea and Vomiting (PONV) - a Study With Data From the Swedish Perioperative Register (SPOR).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04433676
• Other study ID #: SPOR-PONV 1.0
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2020
• Source: Västernorrland County Council, Sweden
• Contact: Jakob Wallden, MD PhD
• Phone: 0046703644392
• Email: jakob.wallden[@]umu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500000
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Complications
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
Sweden	Västernorrland County Council / Sundsvall Hospital	Sundsvall	X

Sponsors (2)

Lead Sponsor	Collaborator
Jakob Wallden	Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PONV	Nausea or Vomiting	At the recovery unit, up to 24 hours after surgery.