PACU for Postoperative Care After Major Thoracic and Abdominal Surgery

NCT ID: NCT05046925

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

18000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-12-31

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.

Conditions

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Anesthesia Surgery--Complications

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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24-hour PACU group

closely monitor in post-anesthetic unit (PACU) and the stay time is less than 24 hours, then patients can be discharged to floor

postoperatively transferral to PACU

Intervention Type PROCEDURE

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

24-hour ICU group

closely monitor in intensive care unit (ICU) and the stay time is less than 24 hours, even patients die within 24 hours in ICU

postoperatively transferral to ICU

Intervention Type PROCEDURE

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

Interventions

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postoperatively transferral to PACU

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

Intervention Type PROCEDURE

postoperatively transferral to ICU

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

Intervention Type PROCEDURE

Other Intervention Names

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24-hour PACU group 24-hour ICU group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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xiangming fang

Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiangming Fang, Professor

Role: PRINCIPAL_INVESTIGATOR

First Affilated Hospital of Zhejiang University

Locations

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First affilated hospital of zhejiang university

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Hui Ye, Doctor

Role: CONTACT

8615267048716

Hui Li, Doctor

Role: CONTACT

8613968190081

Facility Contacts

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Hui Li, Doctor

Role: primary

8613968190081

Hui Li, Professor

Role: backup

8613857161019

References

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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.

Reference Type RESULT
PMID: 27799174 (View on PubMed)

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):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.

Reference Type RESULT
PMID: 18582931 (View on PubMed)

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 Society of the Critical Care Medicine. Workforce, Workload, and Burnout Among Intensivists and Advanced Practice Providers: A Narrative Review. Crit Care Med. 2019 Apr;47(4):550-557. doi: 10.1097/CCM.0000000000003637.

Reference Type RESULT
PMID: 30688716 (View on PubMed)

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 Further Research. Crit Care Med. 2016 Aug;44(8):1553-602. doi: 10.1097/CCM.0000000000001856.

Reference Type RESULT
PMID: 27428118 (View on PubMed)

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. No abstract available.

Reference Type RESULT
PMID: 30247164 (View on PubMed)

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.

Reference Type RESULT
PMID: 23711311 (View on PubMed)

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.

Reference Type RESULT
PMID: 29979999 (View on PubMed)

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 2005-2013: A single center study. J Clin Anesth. 2017 Dec;43:33-38. doi: 10.1016/j.jclinane.2017.09.005. Epub 2017 Sep 30.

Reference Type RESULT
PMID: 28972924 (View on PubMed)

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.

Reference Type RESULT
PMID: 25123092 (View on PubMed)

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.0b013e31817881b3.

Reference Type RESULT
PMID: 18580173 (View on PubMed)

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):R126. doi: 10.1186/cc11428.

Reference Type RESULT
PMID: 22809294 (View on PubMed)

Duke GJ. Metropolitan audit of appropriate referrals refused admission to intensive care. Anaesth Intensive Care. 2004 Oct;32(5):702-6. doi: 10.1177/0310057X0403200518.

Reference Type RESULT
PMID: 15535499 (View on PubMed)

Other Identifiers

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PACU

Identifier Type: -

Identifier Source: org_study_id

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