PACU for Postoperative Care After Major Thoracic and Abdominal Surgery

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05046925
• Other study ID #: PACU
• Status: Not yet recruiting
• Start date: October 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2021
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Hui Ye, Doctor
• Phone: 8615267048716
• Email: 0007--007[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Surgery--Complications

Intervention

Procedure:
• postoperatively transferral to PACU
patients undergoing major thoracic and abdominal surgery will be transferred to PACU for postoperative care.
• postoperatively transferral to ICU
patients undergoing major thoracic and abdominal surgery will be transferred to ICU for postoperative care.

Locations

Country	Name	City	State
China	First affilated hospital of zhejiang university	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (12)

Belcher AW, Leung S, Cohen B, Yang D, Mascha EJ, Turan A, Saager L, Ruetzler K. Incidence of complications in the post-anesthesia care unit and associated healthcare utilization in patients undergoing non-cardiac surgery requiring neuromuscular blockade 2 — View Citation

Duke GJ. Metropolitan audit of appropriate referrals refused admission to intensive care. Anaesth Intensive Care. 2004 Oct;32(5):702-6. — View Citation

Ender J, Borger MA, Scholz M, Funkat AK, Anwar N, Sommer M, Mohr FW, Fassl J. Cardiac surgery fast-track treatment in a postanesthetic care unit: six-month results of the Leipzig fast-track concept. Anesthesiology. 2008 Jul;109(1):61-6. doi: 10.1097/ALN.0 — View Citation

International Surgical Outcomes Study group. Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth. 2016 Oct 31;117(5):601-609. doi: 10.1093/bja/aew316. Erratum in: Br J Anaest — View Citation

Kastrup M, Seeling M, Barthel S, Bloch A, le Claire M, Spies C, Scheller M, Braun J. Effects of intensivist coverage in a post-anaesthesia care unit on surgical patients' case mix and characteristics of the intensive care unit. Crit Care. 2012 Jul 18;16(4 — View Citation

Kellner DB, Urman RD, Greenberg P, Brovman EY. Analysis of adverse outcomes in the post-anesthesia care unit based on anesthesia liability data. J Clin Anesth. 2018 Nov;50:48-56. doi: 10.1016/j.jclinane.2018.06.038. Epub 2018 Jun 29. — View Citation

Lalani SB, Ali F, Kanji Z. Prolonged-stay patients in the PACU: a review of the literature. J Perianesth Nurs. 2013 Jun;28(3):151-5. doi: 10.1016/j.jopan.2012.06.009. Review. — View Citation

Loer SA. Anesthesiologists should bring in their expertise during the early postoperative period to improve surgical outcome. Curr Opin Anaesthesiol. 2018 Dec;31(6):713-715. doi: 10.1097/ACO.0000000000000663. — View Citation

Nates JL, Nunnally M, Kleinpell R, Blosser S, Goldner J, Birriel B, Fowler CS, Byrum D, Miles WS, Bailey H, Sprung CL. ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and — View Citation

Pastores SM, Kvetan V, Coopersmith CM, Farmer JC, Sessler C, Christman JW, D'Agostino R, Diaz-Gomez J, Gregg SR, Khan RA, Kapu AN, Masur H, Mehta G, Moore J, Oropello JM, Price K; Academic Leaders in Critical Care Medicine (ALCCM) Task Force of the Societ — View Citation

Probst S, Cech C, Haentschel D, Scholz M, Ender J. A specialized post anaesthetic care unit improves fast-track management in cardiac surgery: a prospective randomized trial. Crit Care. 2014 Aug 15;18(4):468. doi: 10.1186/s13054-014-0468-2. — View Citation

Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-44. doi: 10.1016/S0140-6736(08)60878-8. Epub — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	in-hospital mortality, 30-day and 90-day mortality	up to 90 days
Secondary	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
Secondary	The time of length of stay (LOS)	LOS in PACU or ICU	within 24 hours postoperatively
Secondary	incidence of care escalation	patients in PACU is transferred to ICU within 24 hours rather than to floor	within 24 hours postoperatively
Secondary	Incidence of major complications	Postoperative major complications, defined by International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes	30 days postoperatively
Secondary	The time of hospital length of stay (LOS)	hospital length of stay (LOS)	up to 30 days
Secondary	medical cost	Any medical cost during hospital stay	up to 90 days]
Secondary	Incidence of emergency department (ED) visits	Emergency department (ED) visits within 90 days of the index surgery	90 days
Secondary	Ventilation time	Ventilation time postoperatively	up 30 days
Secondary	Anaesthetic resuscitation time	Anaesthetic resuscitation time postoperatively	Up to 24 hours