AnesthesiaNCT05626153
Anesthesia Quality Improvement and Patients With Planned ICU Admission
A study testing Routine anesthesia care and Improved anesthesia care in people with Anesthesia and Extubation, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Extubation, Intensive Care Unit
- What is being tested?
- Routine anesthesia care and Improved anesthesia care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Scheduled to undergo elective surgery.
- Planned ICU admission after surgery.
Who cannot join
- Refused to participate in the study.
- ICU admission before surgery.
- Unexpected ICU admission.
- Other conditions that are considered unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Effects of Anesthesia Quality Improvement on Outcomes of Patients With Planned ICU Admission: a Prospective Pre-post Intervention 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. 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.
Read the 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.
- Being tested
- Routine anesthesia care, Improved anesthesia care
- Keywords
- Anesthesia management, Early extubation, Intensive care unit admission, Postoperative Complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine anesthesia careOther
- Implementing anesthesia management according to current routine practice.
Improved anesthesia careOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Routine anesthesia care | Active comparator | • Implementing anesthesia management according to current routine practice. Receives: 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. Receives: Other: Improved anesthesia care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days after surgery
Secondary outcomes (5)
Rate of ICU admission
Rate of ICU admission
Measured: On the 1 day of surgery
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).
Measured: Up to 5 days after surgery
Rate of delayed neurocognitive recovery
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.
Measured: up to 7 days after surgery
Length of stay in hospital after surgery
Length of stay in hospital after surgery
Measured: Up to 30 days after surgery
Medical costs during hospitalization
Medical costs during hospitalization
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Feb 2023
- Primary completion31 Jul 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626153
- Sponsor's protocol ID
- 2022-413
- Status last verified
- Feb 2025
- First submitted
- 15 Nov 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kahan BC, Koulenti D, Arvaniti K, Beavis V, Campbell D, Chan M, Moreno R, Pearse RM; International Surgical Outcomes Study (ISOS) group. Critical care admission following elective surgery was not associated with survival benefit: prospective analysis of data from 27 countries. Intensive Care Med. 2017 Jul;43(7):971-979. doi: 10.1007/s00134-016-4633-8. Epub 2017 Apr 25.
PubMed 28439646Vourc'h M, Asehnoune K. Postoperative admission in surgical ICU, less is more? Anaesth Crit Care Pain Med. 2019 Jun;38(3):217-219. doi: 10.1016/j.accpm.2019.03.006. Epub 2019 Apr 2. No abstract available.
PubMed 30951884Zampieri FG. Elective ICU admission after major surgery: can too much support be futile? J Thorac Dis. 2018 Jun;10(Suppl 17):S1992-S1994. doi: 10.21037/jtd.2018.05.154. No abstract available.
PubMed 30023100Wu XH, Cui F, Zhang C, Meng ZT, Wang DX, Ma J, Wang GF, Zhu SN, Ma D. Low-dose Dexmedetomidine Improves Sleep Quality Pattern in Elderly Patients after Noncardiac Surgery in the Intensive Care Unit: A Pilot Randomized Controlled Trial. Anesthesiology. 2016 Nov;125(5):979-991. doi: 10.1097/ALN.0000000000001325.
PubMed 27571256Anastasian ZH, Gaudet JG, Levitt LC, Mergeche JL, Heyer EJ, Berman MF. Factors that correlate with the decision to delay extubation after multilevel prone spine surgery. J Neurosurg Anesthesiol. 2014 Apr;26(2):167-71. doi: 10.1097/ANA.0000000000000028.
PubMed 24296539Li 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.
PubMed 23934263David 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.
PubMed 28366307Gal 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.
PubMed 34933241Stumpo 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.
PubMed 33962374Brustia 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.
PubMed 33966024Feltracco P, Serra E, Barbieri S, Milevoj M, Salvaterra F, Marulli G, Ori C. Noninvasive ventilation in adult liver transplantation. Transplant Proc. 2008 Jul-Aug;40(6):1979-82. doi: 10.1016/j.transproceed.2008.05.006.
PubMed 18675106Xu Y, Zuo Y, Zhou L, Hao X, Xiao X, Ye M, Bo L, Jiang C, Yang J. Extubation in the operating room results in fewer composite mechanical ventilation-related adverse outcomes in patients after liver transplantation: a retrospective cohort study. BMC Anesthesiol. 2021 Nov 18;21(1):286. doi: 10.1186/s12871-021-01508-1.
PubMed 34794387Khwannimit 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.
PubMed 21946822Clavien 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.
PubMed 19638912
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anesthesia Quality Improvement on Outcomes of Patients With Planned ICU Admission: a Prospective Pre-post Intervention Study
- ClinicalTrials.gov ID
- NCT05626153
- Acronym / sponsor ID
- 2022-413
- Keywords
- Anesthesia management, Early extubation, Intensive care unit admission, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine anesthesia care | Active comparator | Other: Routine anesthesia care• Implementing anesthesia management according to current routine practice. |
| Improved anesthesia care | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Scheduled to undergo elective surgery.
- Planned ICU admission after surgery.
Key exclusion criteria (4 listed)
- Refused to participate in the study.
- ICU admission before surgery.
- Unexpected ICU admission.
- Other conditions that are considered unsuitable for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine anesthesia care• Implementing anesthesia management according to current routine practice. | Other | Routine 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. | Other | Improved anesthesia care |
Primary outcome
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.
5 secondary outcomes
Rate of ICU admission
Time frame: On the 1 day of surgery
Incidence of postoperative delirium
Time frame: Up to 5 days after surgery
Rate of delayed neurocognitive recovery
Time frame: up to 7 days after surgery
Length of stay in hospital after surgery
Time frame: Up to 30 days after surgery
Medical costs during hospitalization
Time frame: Up to 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 28439646Kahan BC, Koulenti D, Arvaniti K, Beavis V, Campbell D, Chan M, Moreno R, Pearse RM; International Surgical Outcomes Study (ISOS) group. Critical care admission following elective surgery was not associated with survival benefit: prospective analysis of data from 27 countries. Intensive Care Med. 2017 Jul;43(7):971-979. doi: 10.1007/s00134-016-4633-8. Epub 2017 Apr 25.
- Background: PubMed 30951884Vourc'h M, Asehnoune K. Postoperative admission in surgical ICU, less is more? Anaesth Crit Care Pain Med. 2019 Jun;38(3):217-219. doi: 10.1016/j.accpm.2019.03.006. Epub 2019 Apr 2. No abstract available.
- Background: PubMed 30023100Zampieri FG. Elective ICU admission after major surgery: can too much support be futile? J Thorac Dis. 2018 Jun;10(Suppl 17):S1992-S1994. doi: 10.21037/jtd.2018.05.154. No abstract available.
- Background: PubMed 27571256Wu XH, Cui F, Zhang C, Meng ZT, Wang DX, Ma J, Wang GF, Zhu SN, Ma D. Low-dose Dexmedetomidine Improves Sleep Quality Pattern in Elderly Patients after Noncardiac Surgery in the Intensive Care Unit: A Pilot Randomized Controlled Trial. Anesthesiology. 2016 Nov;125(5):979-991. doi: 10.1097/ALN.0000000000001325.
- Background: PubMed 24296539Anastasian ZH, Gaudet JG, Levitt LC, Mergeche JL, Heyer EJ, Berman MF. Factors that correlate with the decision to delay extubation after multilevel prone spine surgery. J Neurosurg Anesthesiol. 2014 Apr;26(2):167-71. doi: 10.1097/ANA.0000000000000028.
- Background: PubMed 23934263Li 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.
- Background: PubMed 28366307David 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.
- Background: PubMed 34933241Gal 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.
- Background: PubMed 33962374Stumpo 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.
- Background: PubMed 33966024Brustia 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.
- Background: PubMed 18675106Feltracco P, Serra E, Barbieri S, Milevoj M, Salvaterra F, Marulli G, Ori C. Noninvasive ventilation in adult liver transplantation. Transplant Proc. 2008 Jul-Aug;40(6):1979-82. doi: 10.1016/j.transproceed.2008.05.006.
- Background: PubMed 34794387Xu Y, Zuo Y, Zhou L, Hao X, Xiao X, Ye M, Bo L, Jiang C, Yang J. Extubation in the operating room results in fewer composite mechanical ventilation-related adverse outcomes in patients after liver transplantation: a retrospective cohort study. BMC Anesthesiol. 2021 Nov 18;21(1):286. doi: 10.1186/s12871-021-01508-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine anesthesia care and Improved anesthesia care in people with Anesthesia and Extubation, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative complication (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05626153, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.