PACU for Postoperative Care After Major Thoracic and Abdominal Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia, Surgery--Complications

Intervention / Treatment
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* Procedure: postoperatively transferral to PACU
* Procedure: postoperatively transferral to ICU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 24-hour PACU group<br>closely monitor in post-anesthetic unit (PACU) and the stay time is less than 24 hours, then patients can be discharged to floor | Procedure: postoperatively transferral to PACU<br>* patients undergoing major thoracic and abdominal surgery will be transferred to PACU for postoperative care.<br>* Other names: 24-hour PACU group;|
| 24-hour ICU group<br>closely monitor in intensive care unit (ICU) and the stay time is less than 24 hours, even patients die within 24 hours in ICU | Procedure: postoperatively transferral to ICU<br>* patients undergoing major thoracic and abdominal surgery will be transferred to ICU for postoperative care.<br>* Other names: 24-hour ICU group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | in-hospital mortality, 30-day and 90-day mortality | up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of a composite of all-cause death, re-operation and major postoperative complications within 24 hours post surgery | The primary outcome that will be measured is a composite of all-cause death, re-operation and major postoperative complications within 24 hours post surgery | within 24 hours postoperatively | 
| The time of length of stay (LOS) | LOS in PACU or ICU | within 24 hours postoperatively | 
| incidence of care escalation | patients in PACU is transferred to ICU within 24 hours rather than to floor | within 24 hours postoperatively | 
| Incidence of major complications | Postoperative major complications, defined by International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes | 30 days postoperatively | 
| The time of hospital length of stay (LOS) | hospital length of stay (LOS) | up to 30 days | 
| medical cost | Any medical cost during hospital stay | up to 90 days] | 
| Incidence of emergency department (ED) visits | Emergency department (ED) visits within 90 days of the index surgery | 90 days | 
| Ventilation time | Ventilation time postoperatively | up 30 days | 
| Anaesthetic resuscitation time | Anaesthetic resuscitation time postoperatively | Up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-anesthetic care unit, Intensive care unit, Major surgery, postoperative complications, mortality, safety, efficacy, Postoperative care