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PACU for Postoperative Care After Major Thoracic and Abdominal Surgery

PACU or ICU for Postoperative Care After Major Thoracic and Abdominal Surgery:a Prospective Randomized Clinical Trial

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05046925
Enrollment
18000
Registered
2021-09-16
Start date
2021-10-01
Completion date
2023-12-31
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Surgery--Complications

Keywords

Post-anesthetic care unit, Intensive care unit, Major surgery, postoperative complications, mortality, safety, efficacy, Postoperative care

Brief summary

The aim of this study is to demonstrate the efficacy and safety of a specialised post-anaesthetic care unit (PACU) to a conventional intensive care unit (ICU) in adult patients after major thoracic and abdominal surgery. A better understanding of PACU for postoperative care is likely to reduce mortality and postoperative complications.

Detailed description

With the continuous progress of surgical techniques, the number of major thoracic and abdominal surgeries is also increasing. Although intensive monitoring and initiative treatment benefit patients undergoing major surgery, there is also an increasing demand for intensive care in hospitals, which can lead to capacity limitations in the intensive care unit (ICU). In addition, there is emerging opinion that many patients after major thoracic and abdominal surgery do not require ICU care postoperatively to be provided safe and appropriate care. For hospitals and their staff the challenge is to optimize clinical processes and to optimize the effectiveness of treatment in regard to patient's outcome. Studying patient postoperative care following major thoracic and abdominal surgery exposes many opportunities to the improvement of patient safety, tailor the intensive care resource allocation and consider the costs and benefits of the options. Postoperative mortality and morbidity remain major challenges, and most of these complications develop during the early postoperative period when patients have left the recovery room. Thus improving the care that patients receive once complications have occurred is crucial for reducing mortality. The post-anesthetic care unit (PACU) provides general to intensive care to immediate postsurgical patients. Patients with major thoracic and abdominal surgery surgeries are often kept in PACU until their condition is stabilized before shifting them to their designated wards or ICU\[9\]. Ender et al. and Probs et al. showed that treatment in a specialized PACU rather than an ICU, after cardiac surgery leads to earlier extubation, decreased ICU length of stay (LOS) and quicker discharge of hospital without compromising patient safety. Kastrup et al. described, introduction of a PACU staffed with intensivist coverage around the clock might shorten the hospital LOS and more patients can be treated in the same time, due to a better use of resources. Some other study described the transferral to a PACU as an unfavourable option, since equipment, expertise and staffing levels in the PACU are different from the ICU. The possible solution to this problem might be the inclusion of the PACU in the process of distribution of patients to the different levels of intensive care for ensuring the timely recognition and effective management of postoperative complications in patients after major thoracic and abdominal surgery. The most challenges are to identify those candidates who can be monitored PACU within 24 hours postoperatively, rather than in ICU, and implement change in care paradigms safely.

Interventions

PROCEDUREpostoperatively transferral to PACU

patients undergoing major thoracic and abdominal surgery will be transferred to PACU for postoperative care.

PROCEDUREpostoperatively transferral to ICU

patients undergoing major thoracic and abdominal surgery will be transferred to ICU for postoperative care.

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged 18 years and older * Undergoing major thoracic and abdominal surgery * Postoperative hospital stay expected to be at least one night * Patients requiring less than 24 hour stay in PACU or ICU

Exclusion criteria

* Patients aged less than 18 years * Not receive major thoracic and abdominal surgery * Stay in ICU is over 24 hours * Hospital stay is less than 24 hours * Patient not signing the informed consensus

Design outcomes

Primary

MeasureTime frameDescription
mortalityup to 90 daysin-hospital mortality, 30-day and 90-day mortality

Secondary

MeasureTime frameDescription
Incidence of a composite of all-cause death, re-operation and major postoperative complications within 24 hours post surgerywithin 24 hours postoperativelyThe primary outcome that will be measured is a composite of all-cause death, re-operation and major postoperative complications within 24 hours post surgery
The time of length of stay (LOS)within 24 hours postoperativelyLOS in PACU or ICU
incidence of care escalationwithin 24 hours postoperativelypatients in PACU is transferred to ICU within 24 hours rather than to floor
Incidence of major complications30 days postoperativelyPostoperative major complications, defined by International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes
The time of hospital length of stay (LOS)up to 30 dayshospital length of stay (LOS)
medical costup to 90 days]Any medical cost during hospital stay
Incidence of emergency department (ED) visits90 daysEmergency department (ED) visits within 90 days of the index surgery
Ventilation timeup 30 daysVentilation time postoperatively
Anaesthetic resuscitation timeUp to 24 hoursAnaesthetic resuscitation time postoperatively

Countries

China

Contacts

Primary ContactHui Ye, Doctor
0007--007@163.com8615267048716
Backup ContactHui Li, Doctor
lihuilcyx04@126.com8613968190081

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026