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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05626153
Other study ID # 2022-477
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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 allClick 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
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