Anesthesia Quality Improvement and Patients With Planned ICU Admission

Sponsor
Peking University First Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05626153
Collaborator
(none)
2,000
1
2
19
105.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Routine anesthesia care
  • Other: Improved anesthesia care
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effects of Anesthesia Quality Improvement on Outcomes of Patients With Planned ICU Admission: a Prospective Pre-post Intervention Study
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Routine anesthesia care

• Implementing anesthesia management according to current routine practice.

Other: Routine anesthesia care
• Implementing anesthesia management according to current routine practice.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of postoperative complication [Up to 30 days after surgery]

    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.

Secondary Outcome Measures

  1. Rate of ICU admission [On the 1 day of surgery]

    Rate of ICU admission

  2. Incidence of postoperative delirium [Up to 5 days after surgery]

    Delirium is assessed with the Three-dimensional Confusion Assessment Method (3D-CAM) twice daily (8:00-10:00 am and 18:00-20:00 pm).

  3. Rate of delayed neurocognitive recovery [up to 7 days after surgery]

    Cognitive function is assessed with the Montreal Cognitive Assessment (MoCA) before surgery and at discharge. A decrease of 2 points or more is defined as the development of delayed neurocognitive recovery.

  4. Length of stay in hospital after surgery [Up to 30 days after surgery]

    Length of stay in hospital after surgery

  5. Medical costs during hospitalization [Up to 30 days after surgery]

    Medical costs during hospitalization

Other Outcome Measures

  1. Duration of mechanical ventilation [up to 30 days after surgery]

    Duration of mechanical ventilation

  2. Length of stay in ICU after surgery [Up to 30 days after surgery]

    Length of stay in ICU after surgery

  3. Rate of ICU re-admission [Up to 30 days after surgery]

    ICU re-admission is defined as ICU admission from the general wards after surgery

  4. All-cause 30-day mortality [Up to 30 days after surgery]

    All-cause 30-day mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University First Hospital Beijing Beijing China 100034

Sponsors and Collaborators

  • Peking University First Hospital

Investigators

  • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT05626153
Other Study ID Numbers:
  • 2022-477
First Posted:
Nov 23, 2022
Last Update Posted:
Dec 1, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2022