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NCT Number: NCT05626153

Anesthesia Quality Improvement and Patients With Planned ICU Admission

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine anesthesia care

Other
  • Implementing anesthesia management according to current routine practice.

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.

Primary outcomes

  1. Incidence of postoperative complication

    Time frame: 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 outcomes

  1. Rate of ICU admission

    Time frame: On the 1 day of surgery

    Rate of ICU admission

  2. Incidence of postoperative delirium

    Time frame: 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

    Time frame: up to 7 days after surgery

    Cognitive function is assessed with the Montreal Cognitive Assessment (MoCA) before surgery and at discharge. A decrease of 1 standard deviation (SD) or more from baseline is defined as the development of delayed neurocognitive recovery.

  4. Length of stay in hospital after surgery

    Time frame: Up to 30 days after surgery

    Length of stay in hospital after surgery

  5. Medical costs during hospitalization

    Time frame: Up to 30 days after surgery

    Medical costs during hospitalization

Other outcomes

  1. Duration of mechanical ventilation

    Time frame: up to 30 days after surgery

    Duration of mechanical ventilation

  2. Length of stay in ICU after surgery

    Time frame: Up to 30 days after surgery

    Length of stay in ICU after surgery

  3. Rate of ICU re-admission

    Time frame: 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

    Time frame: Up to 30 days after surgery

    All-cause 30-day mortality

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Effects of Anesthesia Quality Improvement on Outcomes of Patients With Planned ICU Admission: a Prospective Pre-post Intervention Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 23, 2022
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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