PACU for Postoperative Care After Major Thoracic and Abdominal Surgery

NCT05046925 | Unknown

• 1 other identifier: PACU
• Study Type: observational
• Target: 18,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Surgery--Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• mortality

  in-hospital mortality, 30-day and 90-day mortality

  up to 90 days

Secondary Outcomes (9)

• Incidence of 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)

  within 24 hours postoperatively

• incidence of care escalation

  within 24 hours postoperatively

• Incidence of major complications

  30 days postoperatively

• The time of hospital length of stay (LOS)

  up to 30 days

Study Arms (2)

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

Procedure: postoperatively transferral to PACU

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

Procedure: postoperatively transferral to ICU

Interventions

postoperatively transferral to PACU PROCEDURE

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

Also known as: 24-hour PACU group

24-hour PACU group

postoperatively transferral to ICU PROCEDURE

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

Also known as: 24-hour ICU group

24-hour ICU group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing major thoracic and abdominal surgery between September, 2021 and September, 2023 will be included in this study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

First affilated hospital of zhejiang university

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (12)

• 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.

  PMID: 27799174 RESULT

• 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.

  PMID: 18582931 RESULT

• 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.

  PMID: 30688716 RESULT

• 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.

  PMID: 27428118 RESULT

• 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.

  PMID: 30247164 RESULT

• 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.

  PMID: 23711311 RESULT

• 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.

  PMID: 29979999 RESULT

• 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.

  PMID: 28972924 RESULT

• 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.

  PMID: 25123092 RESULT

• 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.

  PMID: 18580173 RESULT

• 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.

  PMID: 22809294 RESULT

• 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.

  PMID: 15535499 RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiangming Fang, Professor

  First Affilated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Ye, Doctor

CONTACT

8615267048716; 0007--007@163.com

Hui Li, Doctor

CONTACT

8613968190081; lihuilcyx04@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 16, 2021
• Study Start: October 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

CN (1)