CompletedNot Applicable

Observational Study of Early Postoperative Deterioration and Complications

Denmark240 participantsStarted 2023-10-03

Plain-language summary

This prospective observational research project aims to investigate how vital sign deterioration and complications within the (PACU) relate to early deterioration and complications in the surgical wards 72 hours post-PACU discharge. The participants studied will be high-risk surgical patients who will follow a normal postoperative course from the PACU to the surgical ward. The investigators seek to evaluate the association between deterioration and complications within the PACU with vital signs deterioration and complications in the surgical wards. Second, the investigators will explore how deterioration and complications affect PACU length of stay, morbidity, mortality, rapid response Teams call-outs (RRT) (Early warning score \>7), extra medical patient supervision, and unplanned intensive care unit (ICU) admissions. The investigators will also examine the nurses' assessment of the patient's risk of deterioration and complications upon discharge from the PACU and admission to the surgical department.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

Adult patients undergoing surgery for a hip fracture, lower limb amputation, open liver resection, open pancreatic, and esophageal/gastric surgery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The incidence of deterioration and complications during the first 72 hours post-PACU discharge and its association with deterioration and complication rates in the PACU

Timeframe: Up to three days

The incidence of deterioration and complications during PACU stay

Timeframe: Up to four our days

Trial details

NCT IDNCT06013891

SponsorCopenhagen University Hospital, Hvidovre

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-04-03

View on ClinicalTrials.gov More Postoperative Complications trials