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Anesthesia Quality Improvement and Patients With Planned ICU Admission

Primary Purpose

Anesthesia, Extubation, Intensive Care Unit

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Routine anesthesia care
Improved anesthesia care
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia focused on measuring Anesthesia management, Early extubation, Intensive care unit admission, Postoperative Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine anesthesia care

Improved anesthesia care

Arm Description

• Implementing anesthesia management according to current routine practice.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of ICU admission
Rate of ICU admission
Incidence of postoperative delirium
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
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.
Length of stay in hospital after surgery
Length of stay in hospital after surgery
Medical costs during hospitalization
Medical costs during hospitalization

Full Information

First Posted
November 15, 2022
Last Updated
November 28, 2022
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05626153
Brief Title
Anesthesia Quality Improvement and Patients With Planned ICU Admission
Official Title
Effects of Anesthesia Quality Improvement on Outcomes of Patients With Planned ICU Admission: a Prospective Pre-post Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Extubation, Intensive Care Unit, Postoperative Complications
Keywords
Anesthesia management, Early extubation, Intensive care unit admission, Postoperative Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine anesthesia care
Arm Type
Active Comparator
Arm Description
• Implementing anesthesia management according to current routine practice.
Arm Title
Improved anesthesia care
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Routine anesthesia care
Intervention Description
• Implementing anesthesia management according to current routine practice.
Intervention Type
Other
Intervention Name(s)
Improved anesthesia care
Intervention Description
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 Measure Information:
Title
Incidence of postoperative complication
Description
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.
Time Frame
Up to 30 days after surgery
Secondary Outcome Measure Information:
Title
Rate of ICU admission
Description
Rate of ICU admission
Time Frame
On the 1 day of surgery
Title
Incidence of postoperative delirium
Description
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).
Time Frame
Up to 5 days after surgery
Title
Rate of delayed neurocognitive recovery
Description
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.
Time Frame
up to 7 days after surgery
Title
Length of stay in hospital after surgery
Description
Length of stay in hospital after surgery
Time Frame
Up to 30 days after surgery
Title
Medical costs during hospitalization
Description
Medical costs during hospitalization
Time Frame
Up to 30 days after surgery
Other Pre-specified Outcome Measures:
Title
Duration of mechanical ventilation
Description
Duration of mechanical ventilation
Time Frame
up to 30 days after surgery
Title
Length of stay in ICU after surgery
Description
Length of stay in ICU after surgery
Time Frame
Up to 30 days after surgery
Title
Rate of ICU re-admission
Description
ICU re-admission is defined as ICU admission from the general wards after surgery
Time Frame
Up to 30 days after surgery
Title
All-cause 30-day mortality
Description
All-cause 30-day mortality
Time Frame
Up to 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Xin Wang, MD, PhD
Phone
8610-83572784
Email
wangdongxin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fan Cui, MD
Phone
8610-83572460
Email
cuifan_1987@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD
Phone
8610-83572784
Email
wangdongxin@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Anesthesia Quality Improvement and Patients With Planned ICU Admission

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