Postoperative ComplicationsNCT06013891
Observational Study of Early Postoperative Deterioration and Complications
An observational study of Postoperative Complications and Deterioration, Clinical, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Deterioration, Clinical, Postoperative Care
- How many people
- 240 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Oct 2023to 3 Apr 2024
- 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: We will include approximately 250 adults undergoing surgery for hip fracture, lower limb amputation, open liver resection, open pancreatic and esophageal/gastric surgery, and open or laparoscopic major abdominal surgery. The surgical patient categories are selected based on types of surgery performed at the research sites, clinical experience, and well-known high risks of postoperative morbidity and mortality.
Who may be able to join
- -Adult patients undergoing surgery for a hip fracture, lower limb amputation, open liver resection, open pancreatic, and esophageal/gastric surgery
- And
- Adult patients undergoing open or laparoscopic major abdominal surgery and orthopedic surgery
- Surgery time over 2 hours
- American Society of Anesthesiologists (ASA) physical status classification system 3 - 4
Who cannot join
- Pre-planned fixed minimum PACU stay
- Planned intensive care unit (ICU) stay
- Terminally ill
- Incapable of giving informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence and Association of PACU Course and Early Postoperative Complications and Deterioration
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.
Read the detailed description
Postoperative complications are increasing and are an under-recognized cause of morbidity and mortality. While there has been significant attention to preoperative risk assessments for late postoperative complications and 30-day mortality, little attention has been paid to the PACU as a point of in-patient triage for early postoperative deterioration and complications. PACU to surgical ward discharge readiness is often based on a quantitative discharge score that does not account for the patient's physiological responses or distinguish between surgery type, age, and co-morbidities.
The discharge score is a clinical decision-making tool that sets the frame for the patient's readiness for discharge and functions as a "one six fits all" system. However, this "one size fits all" approach may not be adequate as a discharge tool when discharging high-risk, fragile patients from the PACU. The current evidence on using criterion-based discharge scores and the connection with early postoperative deterioration and complications are absent and need further investigation.
It is unclear whether early postoperative deterioration and complications can be predicted and assessed during PACU stay. Thus leaving a big potential for improvement in patient assessment and detection of early deterioration and complications, improving safe PACU discharge for high-risk fragile patients. Providing new knowledge on early postoperative deterioration and complications within high-risk, fragile patient groups could improve postoperative courses and patient safety.
Statistical analysis plan Data is expected to be divided into two (or 3) consecutive studies.
- Keywords
- Postoperative Complications, Deterioration, Clinical, Postoperative Care, Clinical assessment
- Medical subject headings
- Postoperative Complications, Clinical Deterioration
What is being measured
The primary outcome is the main question the study is designed to answer.
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
In accordance with ICH-GCP: any untoward medical occurrence that(...)
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or causes prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- Requires intervention to prevent permanent impairment or damage And/or severe deviating vital signs defined as outside normal thresholds.
Measured: Up to three days
The incidence of deterioration and complications during PACU stay
In accordance with ICH-GCP: any untoward medical occurrence that(...)
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or causes prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- Requires intervention to prevent permanent impairment or damage And/or severe deviating vital signs defined as outside normal thresholds.
Measured: Up to four our days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start3 Oct 2023
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lea Baunegaard Hvidberg, Copenhagen University Hospital, Hvidovre
- Investigators
- Lea B Hvidberg, RN, Ms.c., Principal investigator, Dep. of Anesthesiology, Amager and Hvidovre University HospitalEske K Aasvang, MD,Med.Sc.D., Study chair, Centre for Cancer and Organ Diseases, Rigshospitalet, University HospitalMartin G Tolsgaard, MD,Med.Sc.D., Study chair, CAMES Rigshospitalet and Department of Obstetrics, Rigshospitalet, University HospitalNicolai B Foss, MD,Med.Sc.D., Study chair, Department of Anesthesiology, Amager and Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013891
- Sponsor's protocol ID
- F-22045028
- Status last verified
- Jan 2026
- First submitted
- 7 Jul 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Hvidberg LB, Aasvang EK, Bak E, Bank V, Poulsen LR, Tolsgaard MG, Foss NB. Beyond discharge score: postoperative care unit nurses' clinical assessments improve postoperative risk stratification: A prospective cohort study. Eur J Anaesthesiol. 2026 Aug 1;43(8):703-711. doi: 10.1097/EJA.0000000000002362. Epub 2026 Mar 10.
PubMed 41804675
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Association of PACU Course and Early Postoperative Complications and Deterioration
- ClinicalTrials.gov ID
- NCT06013891
- Acronym / sponsor ID
- F-22045028
- Keywords
- Postoperative Complications, Deterioration, Clinical, Postoperative Care, Clinical assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 28 Aug 2023 (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.
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.
Detailed description
Postoperative complications are increasing and are an under-recognized cause of morbidity and mortality. While there has been significant attention to preoperative risk assessments for late postoperative complications and 30-day mortality, little attention has been paid to the PACU as a point of in-patient triage for early postoperative deterioration and complications. PACU to surgical ward discharge readiness is often based on a quantitative discharge score that does not account for the patient's physiological responses or distinguish between surgery type, age, and co-morbidities.
The discharge score is a clinical decision-making tool that sets the frame for the patient's readiness for discharge and functions as a "one six fits all" system. However, this "one size fits all" approach may not be adequate as a discharge tool when discharging high-risk, fragile patients from the PACU. The current evidence on using criterion-based discharge scores and the connection with early postoperative deterioration and complications are absent and need further investigation.
It is unclear whether early postoperative deterioration and complications can be predicted and assessed during PACU stay. Thus leaving a big potential for improvement in patient assessment and detection of early deterioration and complications, improving safe PACU discharge for high-risk fragile patients. Providing new knowledge on early postoperative deterioration and complications within high-risk, fragile patient groups could improve postoperative courses and patient safety.
Statistical analysis plan Data is expected to be divided into two (or 3) consecutive studies.
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
- We will include approximately 250 adults undergoing surgery for hip fracture, lower limb amputation, open liver resection, open pancreatic and esophageal/gastric surgery, and open or laparoscopic major abdominal surgery. The surgical patient categories are selected based on types of surgery performed at the research sites, clinical experience, and well-known high risks of postoperative morbidity and mortality.
Key inclusion criteria (5 listed)
- -Adult patients undergoing surgery for a hip fracture, lower limb amputation, open liver resection, open pancreatic, and esophageal/gastric surgery
- And
- Adult patients undergoing open or laparoscopic major abdominal surgery and orthopedic surgery
- Surgery time over 2 hours
- American Society of Anesthesiologists (ASA) physical status classification system 3 - 4
Key exclusion criteria (4 listed)
- Pre-planned fixed minimum PACU stay
- Planned intensive care unit (ICU) stay
- Terminally ill
- Incapable of giving informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Up to three days
In accordance with ICH-GCP: any untoward medical occurrence that(...) * Results in death * Is life-threatening * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Requires intervention to prevent permanent impairment or damage And/or severe deviating vital signs defined as outside normal thresholds.
The incidence of deterioration and complications during PACU stay
Time frame: Up to four our days
In accordance with ICH-GCP: any untoward medical occurrence that(...) * Results in death * Is life-threatening * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Requires intervention to prevent permanent impairment or damage And/or severe deviating vital signs defined as outside normal thresholds.
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 21 Jan 2026.
- Derived from this study: PubMed 41804675Hvidberg LB, Aasvang EK, Bak E, Bank V, Poulsen LR, Tolsgaard MG, Foss NB. Beyond discharge score: postoperative care unit nurses' clinical assessments improve postoperative risk stratification: A prospective cohort study. Eur J Anaesthesiol. 2026 Aug 1;43(8):703-711. doi: 10.1097/EJA.0000000000002362. Epub 2026 Mar 10.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Lea B Hvidberg, RN, Ms.c. principal investigator
Dep. of Anesthesiology, Amager and Hvidovre University Hospital
Eske K Aasvang, MD,Med.Sc.D. study chair
Centre for Cancer and Organ Diseases, Rigshospitalet, University Hospital
Martin G Tolsgaard, MD,Med.Sc.D. study chair
CAMES Rigshospitalet and Department of Obstetrics, Rigshospitalet, University Hospital
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 Complications and Deterioration, Clinical, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
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 5 inclusion and 4 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 21 Jan 2026. 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 Denmark. 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?
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 (time frame: Up to three days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06013891, which also lists 1 linked publication.
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 21 Jan 2026.