Anesthesia Quality Improvement and Patients With Planned ICU Admission

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05626153
• Other study ID #: 2022-477
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: July 2024

Study information

• Verified date: November 2022
• Source: Peking University First Hospital
• Contact: Dong-Xin Wang, MD, PhD
• Phone: 8610-83572784
• Email: wangdongxin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Extubation
• Intensive Care Unit
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (14)

Anastasian 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. — View Citation

Brustia 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. — View Citation

Clavien 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. — View Citation

David 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. — View Citation

Feltracco 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. — View Citation

Gal 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. — View Citation

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. — View Citation

Khwannimit 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. — View Citation

Li 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. — View Citation

Stumpo 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 7:1-25. doi: 10.3171/2020.10.JNS203160. Online ahead of print. — View Citation

Vourc'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. — View Citation

Wu 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. — View Citation

Xu 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. — View Citation

Zampieri 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of mechanical ventilation	Duration of mechanical ventilation	up to 30 days after surgery
Other	Length of stay in ICU after surgery	Length of stay in ICU after surgery	Up to 30 days after surgery
Other	Rate of ICU re-admission	ICU re-admission is defined as ICU admission from the general wards after surgery	Up to 30 days after surgery
Other	All-cause 30-day mortality	All-cause 30-day mortality	Up to 30 days after surgery
Primary	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.	Up to 30 days after surgery
Secondary	Rate of ICU admission	Rate of ICU admission	On the 1 day of surgery
Secondary	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).	Up to 5 days after surgery
Secondary	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.	up to 7 days after surgery
Secondary	Length of stay in hospital after surgery	Length of stay in hospital after surgery	Up to 30 days after surgery
Secondary	Medical costs during hospitalization	Medical costs during hospitalization	Up to 30 days after surgery