PACU for Postoperative Care After Major Thoracic and Abdominal Surgery

• Conditions: Anesthesia; Surgery--Complications
• Interventions: Procedure: postoperatively transferral to ICU; Procedure: postoperatively transferral to PACU

• Registration Number: NCT05046925
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-04
• Study First Submitted QC: 2021-09-13
• Last Update Submitted: 2021-09-13
• Study First Posted: 2021-09-16
• Last Update Posted: 2021-09-16
• Study Start: 2021-10-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
24-hour ICU group	postoperatively transferral to ICU	closely monitor in intensive care unit (ICU) and the stay time is less than 24 hours, even patients die within 24 hours in ICU
24-hour PACU group	postoperatively transferral to PACU	closely monitor in post-anesthetic unit (PACU) and the stay time is less than 24 hours, then patients can be discharged to floor

Primary Outcome Measures

Name	Time	Method
mortality	up to 90 days	in-hospital mortality, 30-day and 90-day mortality

Secondary Outcome Measures

Name	Time	Method
incidence of care escalation	within 24 hours postoperatively	patients in PACU is transferred to ICU within 24 hours rather than to floor
Incidence of a composite of all-cause death, re-operation and major postoperative complications within 24 hours post surgery	within 24 hours postoperatively	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
The time of length of stay (LOS)	within 24 hours postoperatively	LOS in PACU or ICU
Incidence of major complications	30 days postoperatively	Postoperative 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 days	hospital length of stay (LOS)
medical cost	up to 90 days]	Any medical cost during hospital stay
Ventilation time	up 30 days	Ventilation time postoperatively
Incidence of emergency department (ED) visits	90 days	Emergency department (ED) visits within 90 days of the index surgery
Anaesthetic resuscitation time	Up to 24 hours	Anaesthetic resuscitation time postoperatively

Trial Locations

Locations (1)

First affilated hospital of zhejiang university; 🇨🇳 Hangzhou, Zhejiang, China