Anesthesia Quality Improvement and Patients With Planned ICU Admission

NCT ID: NCT05626153

Last Updated: 2025-02-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-08-31

Brief Summary

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Intensive care unit (ICU) is an important part of perioperative management for high-risk patients but is associated with higher medical costs. Improper ICU admission may produce overtreatment without beneficial effects. In clinical practice, delayed recovery after general anesthesia is a common indication for ICU admission after surgery. The concept of Enhanced Recovery After Surgery recommends early extubation. The investigators suppose that, for patients with planned ICU admission after elective surgery, implementing anesthesia quality improvement including extubation in the operating room will reduce the rate of ICU admission after surgery without increasing complications.

Detailed Description

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Intensive care unit (ICU) is an important part of perioperative management for high-risk patients but is associated with higher medical costs. Improper ICU admission may produce overtreatment without beneficial effects. Studies found that immediate ICU admission after surgery did not reduce the perioperative mortality. Some authors suggested that the indication of ICU admission should be the occurrence of postoperative complications, which will reasonably reduce the use of medical resources.

In clinical practice, delayed recovery after general anesthesia is a common indication for ICU admission after surgery. Old age, high ASA grade, respiratory complications, long duration surgery, large-volume fluid infusion, and use of vasopressors were main factors associated with delayed recovery. The concept of Enhanced Recovery After Surgery recommends early extubation after surgery. Studies showed that, for patients after organ transplantation, immediate extubation in the operating room can shorten hospital stay and reduce medical costs, without increasing mortality.

The investigators suppose that, for patients with planned ICU admission after elective surgery, implementing anesthesia quality improvement including extubation in the operating room will reduce the rate of ICU admission after surgery without increasing postoperative complications.

Conditions

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Anesthesia Extubation Intensive Care Unit Postoperative Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Routine anesthesia care

• Implementing anesthesia management according to current routine practice.

Group Type ACTIVE_COMPARATOR

Routine anesthesia care

Intervention Type OTHER

• Implementing anesthesia management according to current routine practice.

Improved anesthesia care

* Encourage regional anesthesia or combined regional-general anesthesia.
* Encourage goal-directed fluid therapy, lung-protective ventilation, and active warming during surgery.
* Encourage extubation in the operating room at the end of surgery.
* Encourage multimodal analgesia after surgery.
* Encourage strict indication for ICU admission after surgery.

Group Type EXPERIMENTAL

Improved anesthesia care

Intervention Type OTHER

* Encourage regional anesthesia or combined regional-general anesthesia.
* Encourage goal-directed fluid therapy, lung-protective ventilation, and active warming during surgery.
* Encourage extubation in the operating room at the end of surgery.
* Encourage multimodal analgesia after surgery.
* Encourage strict indication for ICU admission after surgery.

Interventions

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Routine anesthesia care

• Implementing anesthesia management according to current routine practice.

Intervention Type OTHER

Improved anesthesia care

* Encourage regional anesthesia or combined regional-general anesthesia.
* Encourage goal-directed fluid therapy, lung-protective ventilation, and active warming during surgery.
* Encourage extubation in the operating room at the end of surgery.
* Encourage multimodal analgesia after surgery.
* Encourage strict indication for ICU admission after surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years.
* Scheduled to undergo elective surgery.
* Planned ICU admission after surgery.

Exclusion Criteria

* Refused to participate in the study.
* ICU admission before surgery.
* Unexpected ICU admission.
* Other conditions that are considered unsuitable for study participation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Xin Wang

Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong-Xin Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Kahan BC, Koulenti D, Arvaniti K, Beavis V, Campbell D, Chan M, Moreno R, Pearse RM; International Surgical Outcomes Study (ISOS) group. Critical care admission following elective surgery was not associated with survival benefit: prospective analysis of data from 27 countries. Intensive Care Med. 2017 Jul;43(7):971-979. doi: 10.1007/s00134-016-4633-8. Epub 2017 Apr 25.

Reference Type BACKGROUND
PMID: 28439646 (View on PubMed)

Vourc'h M, Asehnoune K. Postoperative admission in surgical ICU, less is more? Anaesth Crit Care Pain Med. 2019 Jun;38(3):217-219. doi: 10.1016/j.accpm.2019.03.006. Epub 2019 Apr 2. No abstract available.

Reference Type BACKGROUND
PMID: 30951884 (View on PubMed)

Zampieri FG. Elective ICU admission after major surgery: can too much support be futile? J Thorac Dis. 2018 Jun;10(Suppl 17):S1992-S1994. doi: 10.21037/jtd.2018.05.154. No abstract available.

Reference Type BACKGROUND
PMID: 30023100 (View on PubMed)

Wu XH, Cui F, Zhang C, Meng ZT, Wang DX, Ma J, Wang GF, Zhu SN, Ma D. Low-dose Dexmedetomidine Improves Sleep Quality Pattern in Elderly Patients after Noncardiac Surgery in the Intensive Care Unit: A Pilot Randomized Controlled Trial. Anesthesiology. 2016 Nov;125(5):979-991. doi: 10.1097/ALN.0000000000001325.

Reference Type BACKGROUND
PMID: 27571256 (View on PubMed)

Anastasian ZH, Gaudet JG, Levitt LC, Mergeche JL, Heyer EJ, Berman MF. Factors that correlate with the decision to delay extubation after multilevel prone spine surgery. J Neurosurg Anesthesiol. 2014 Apr;26(2):167-71. doi: 10.1097/ANA.0000000000000028.

Reference Type BACKGROUND
PMID: 24296539 (View on PubMed)

Li F, Gorji R, Tallarico R, Dodds C, Modes K, Mangat S, Yang ZJ. Risk factors for delayed extubation in thoracic and lumbar spine surgery: a retrospective analysis of 135 patients. J Anesth. 2014 Apr;28(2):161-6. doi: 10.1007/s00540-013-1689-2. Epub 2013 Aug 9.

Reference Type BACKGROUND
PMID: 23934263 (View on PubMed)

David RA, Brooke BS, Hanson KT, Goodney PP, Genovese EA, Baril DT, Gloviczki P, DeMartino RR. Early extubation is associated with reduced length of stay and improved outcomes after elective aortic surgery in the Vascular Quality Initiative. J Vasc Surg. 2017 Jul;66(1):79-94.e14. doi: 10.1016/j.jvs.2016.12.122. Epub 2017 Mar 31.

Reference Type BACKGROUND
PMID: 28366307 (View on PubMed)

Gal J, Hunter S, Reich D, Franz E, DeMaria S, Neifert S, Lin HM, Liu X, Caridi J, Katz D. Delayed extubation in spine surgery is associated with increased postoperative complications and hospital episode-based resource utilization. J Clin Anesth. 2022 May;77:110636. doi: 10.1016/j.jclinane.2021.110636. Epub 2021 Dec 20.

Reference Type BACKGROUND
PMID: 34933241 (View on PubMed)

Stumpo V, Staartjes VE, Quddusi A, Corniola MV, Tessitore E, Schroder ML, Anderer EG, Stienen MN, Serra C, Regli L. Enhanced Recovery After Surgery strategies for elective craniotomy: a systematic review. J Neurosurg. 2021 May 7;135(6):1857-1881. doi: 10.3171/2020.10.JNS203160. Print 2021 Dec 1.

Reference Type BACKGROUND
PMID: 33962374 (View on PubMed)

Brustia R, Monsel A, Skurzak S, Schiffer E, Carrier FM, Patrono D, Kaba A, Detry O, Malbouisson L, Andraus W, Vandenbroucke-Menu F, Biancofiore G, Kaido T, Compagnon P, Uemoto S, Rodriguez Laiz G, De Boer M, Orloff S, Melgar P, Buis C, Zeillemaker-Hoekstra M, Usher H, Reyntjens K, Baird E, Demartines N, Wigmore S, Scatton O. Guidelines for Perioperative Care for Liver Transplantation: Enhanced Recovery After Surgery (ERAS) Recommendations. Transplantation. 2022 Mar 1;106(3):552-561. doi: 10.1097/TP.0000000000003808.

Reference Type BACKGROUND
PMID: 33966024 (View on PubMed)

Feltracco P, Serra E, Barbieri S, Milevoj M, Salvaterra F, Marulli G, Ori C. Noninvasive ventilation in adult liver transplantation. Transplant Proc. 2008 Jul-Aug;40(6):1979-82. doi: 10.1016/j.transproceed.2008.05.006.

Reference Type BACKGROUND
PMID: 18675106 (View on PubMed)

Xu Y, Zuo Y, Zhou L, Hao X, Xiao X, Ye M, Bo L, Jiang C, Yang J. Extubation in the operating room results in fewer composite mechanical ventilation-related adverse outcomes in patients after liver transplantation: a retrospective cohort study. BMC Anesthesiol. 2021 Nov 18;21(1):286. doi: 10.1186/s12871-021-01508-1.

Reference Type BACKGROUND
PMID: 34794387 (View on PubMed)

Khwannimit B, Bhurayanontachai R. Prediction of fluid responsiveness in septic shock patients: comparing stroke volume variation by FloTrac/Vigileo and automated pulse pressure variation. Eur J Anaesthesiol. 2012 Feb;29(2):64-9. doi: 10.1097/EJA.0b013e32834b7d82.

Reference Type BACKGROUND
PMID: 21946822 (View on PubMed)

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

Reference Type BACKGROUND
PMID: 19638912 (View on PubMed)

Other Identifiers

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2022-413

Identifier Type: -

Identifier Source: org_study_id

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