Anesthesia Quality Improvement and Patients With Planned ICU Admission

Not Applicable

Completed

• Conditions: Anesthesia; Extubation; Postoperative Complications; Intensive Care Unit
• Interventions: Other: Routine anesthesia care; Other: Improved anesthesia care

• Registration Number: NCT05626153
• Lead Sponsor: Peking University First Hospital

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.

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 Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-22
• Study First Posted: 2022-11-23
• Study Start: 2023-02-01
• Primary Completion: 2024-07-31
• Study Completion: 2024-08-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Routine anesthesia care	Routine anesthesia care	• Implementing anesthesia management according to current routine practice.
Improved anesthesia care	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Rate of ICU admission	On the 1 day of surgery	Rate of ICU admission
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).
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 1 standard deviation (SD) or more from baseline is defined as the development of delayed neurocognitive recovery.
Length of stay in hospital after surgery	Up to 30 days after surgery	Length of stay in hospital after surgery
Medical costs during hospitalization	Up to 30 days after surgery	Medical costs during hospitalization

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China