PACU for Postoperative Care After Major Thoracic and Abdominal Surgery

September 13, 2021 updated by: xiangming fang, First Affiliated Hospital of Zhejiang University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

18000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • First Affilated Hospital of Zhejiang University
        • Contact:
        • Principal Investigator:
          • Hui Ye, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
patients undergoing major thoracic and abdominal surgery will be transferred to PACU for postoperative care.
Other Names:
  • 24-hour PACU group
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
patients undergoing major thoracic and abdominal surgery will be transferred to ICU for postoperative care.
Other Names:
  • 24-hour ICU group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: up to 90 days
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
Time Frame: 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
within 24 hours postoperatively
The time of length of stay (LOS)
Time Frame: within 24 hours postoperatively
LOS in PACU or ICU
within 24 hours postoperatively
incidence of care escalation
Time Frame: within 24 hours postoperatively
patients in PACU is transferred to ICU within 24 hours rather than to floor
within 24 hours postoperatively
Incidence of major complications
Time Frame: 30 days postoperatively
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)
Time Frame: up to 30 days
hospital length of stay (LOS)
up to 30 days
medical cost
Time Frame: up to 90 days]
Any medical cost during hospital stay
up to 90 days]
Incidence of emergency department (ED) visits
Time Frame: 90 days
Emergency department (ED) visits within 90 days of the index surgery
90 days
Ventilation time
Time Frame: up 30 days
Ventilation time postoperatively
up 30 days
Anaesthetic resuscitation time
Time Frame: Up to 24 hours
Anaesthetic resuscitation time postoperatively
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 4, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PACU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Share all the data after the first article was published on issue

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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