Anesthesia Quality Improvement and Patients With Planned ICU Admission

NCT05626153 | Completed DMC

• 1 other identifier: 2022-413
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Extubation; Intensive Care Unit; Postoperative Complications

Keywords

Anesthesia management; Early extubation; Intensive care unit admission; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative complication

  Postoperative complications are defined as newly occurred medical conditions that are considered harmful to patients' recovery and require therapeutic intervention, that is grade II or higher on Clavin-Dindo classification.

  Up to 30 days after surgery

Secondary Outcomes (5)

• Rate of ICU admission

  On the 1 day of surgery

• Incidence of postoperative delirium

  Up to 5 days after surgery

• Rate of delayed neurocognitive recovery

  up to 7 days after surgery

• Length of stay in hospital after surgery

  Up to 30 days after surgery

• Medical costs during hospitalization

  Up to 30 days after surgery

Other Outcomes (4)

• Duration of mechanical ventilation

  up to 30 days after surgery

• Length of stay in ICU after surgery

  Up to 30 days after surgery

• Rate of ICU re-admission

  Up to 30 days after surgery

Study Arms (2)

Routine anesthesia care

ACTIVE COMPARATOR

• Implementing anesthesia management according to current routine practice.

Other: Routine anesthesia care

Improved anesthesia care

EXPERIMENTAL

* 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.

Other: Improved anesthesia care

Interventions

Routine anesthesia care OTHER

• Implementing anesthesia management according to current routine practice.

Routine anesthesia care

Improved anesthesia care 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.

Improved anesthesia care

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (14)

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  PMID: 28439646 BACKGROUND

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  PMID: 30951884 BACKGROUND

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  PMID: 30023100 BACKGROUND

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  PMID: 27571256 BACKGROUND

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  PMID: 24296539 BACKGROUND

• 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.

  PMID: 23934263 BACKGROUND

• 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.

  PMID: 28366307 BACKGROUND

• 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.

  PMID: 34933241 BACKGROUND

• 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.

  PMID: 33962374 BACKGROUND

• 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.

  PMID: 33966024 BACKGROUND

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  PMID: 18675106 BACKGROUND

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  PMID: 34794387 BACKGROUND

• 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.

  PMID: 21946822 BACKGROUND

• 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.

  PMID: 19638912 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: February 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)