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Neurological Complications and ICU Workload After Emergency Repair of Acute Type A Aortic Dissection

NCT ID: NCT07167628

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

274 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-04-30

Brief Summary

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Single-center retrospective cohort at China Medical University Hospital (Taichung, Taiwan) using fully de-identified electronic health records. Consecutive adults who underwent emergency repair of acute type A aortic dissection between 2021-01-01 and 2025-04-30 were pooled into one cohort. The study measures the incidence and patterns of early postoperative neurological complications and evaluates their association with intensive care unit (ICU) resource use, focusing on prolonged ICU length of stay (LOS ≥ 10 days), ICU and hospital LOS, and duration of mechanical ventilation (MV). No new data collection or patient contact occurs. Institutional Review Board (IRB) approval: CMUH114-REC1-139.

Detailed Description

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Adults (≥ 18 years) undergoing emergency repair for acute type A aortic dissection (ATAAD) at China Medical University Hospital (CMUH) during 2021-01-01 to 2025-04-30 were screened. Exclusions: missing key variables, preoperative stroke within 30 days or modified Rankin Scale (mRS) ≥ 4, pregnancy. The analytic cohort included 274 of 309 screened patients. Neurological complications comprise radiology-confirmed stroke, other focal neurological deficits, paraplegia, or sustained coma/encephalopathy recorded by neurology consultation. Prolonged ICU stay is prespecified as ICU LOS ≥ 10 days in the index admission. Outcomes: primary outcomes are prolonged ICU stay and any postoperative neurological complication; secondary outcomes are ICU LOS (days), duration of mechanical ventilation (hours), hospital LOS (days), in-hospital mortality, and in-hospital death within 30 days of the index surgery. Analyses are performed in R version 4.5.1. Continuous variables are summarized as medians with interquartile ranges (IQRs) and compared using the Mann-Whitney U test; categorical variables are presented as counts and percentages and compared using chi-square or Fisher exact tests. Multivariable logistic regression identifies factors associated with prolonged ICU stay (ICU LOS ≥ 10 days) among hospital survivors using a priori covariates (age, sex, chronic kidney disease stage 4-5, operation time, cardiopulmonary bypass \[CPB\] time, intraoperative red blood cell \[RBC\] units transfused, postoperative acute kidney injury \[AKI\], any postoperative neurological complication). A prespecified sensitivity analysis in the full cohort treats the endpoint as ICU LOS ≥ 10 days or in-hospital death using the same prespecified covariates. Data were de-identified before analysis and stored on secure hospital servers; the study is minimal risk and does not involve United States Food and Drug Administration (US FDA) regulated products.

Conditions

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Aortic Dissection Stroke Paraplegia AKI - Acute Kidney Injury Coma Delirium

Keywords

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Acute type A aortic dissection Neurological complications Intensive care unit ICU workload ICU length of stay Mechanical ventilation Hospital length of stay Retrospective cohort Nursing workload Taiwan

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Adults undergoing emergency ATAAD repair

Single-center retrospective cohort of consecutive adults (≥18 years) who underwent emergency repair of acute type A aortic dissection at China Medical University Hospital between 2021-01-01 and 2025-04-30; all participants are pooled into one cohort with no protocol-assigned interventions; outcomes are obtained from de-identified records to assess neurological complications and ICU resource use.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adults (≥18 years) who underwent emergency repair of acute type A aortic dissection at China Medical University Hospital between 2021-01-01 and 2025-04-30.

Exclusion Criteria

* Missing data in key variables required for analyses.
* Preoperative ischemic stroke within 30 days before surgery or preoperative modified Rankin Scale ≥4.
* Pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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En-Bo Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, Taichung City, Taiwan

Site Status

Countries

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Taiwan

References

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Reference Type BACKGROUND
PMID: 17941715 (View on PubMed)

Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

Reference Type BACKGROUND
PMID: 22890468 (View on PubMed)

Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.

Reference Type BACKGROUND
PMID: 23652265 (View on PubMed)

Queijo AF, Martins RS, Andolhe R, Oliveira EM, Barbosa RL, Padilha KG. Nursing workload in neurological intensive care units: cross-sectional study. Intensive Crit Care Nurs. 2013 Apr;29(2):112-6. doi: 10.1016/j.iccn.2012.08.001. Epub 2012 Sep 19.

Reference Type BACKGROUND
PMID: 22999497 (View on PubMed)

Branch-Elliman W, Wright SB, Gillis JM, Howell MD. Estimated nursing workload for the implementation of ventilator bundles. BMJ Qual Saf. 2013 Apr;22(4):357-61. doi: 10.1136/bmjqs-2012-001372. Epub 2013 Feb 21.

Reference Type BACKGROUND
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Lewis K, Balas MC, Stollings JL, McNett M, Girard TD, Chanques G, Kho ME, Pandharipande PP, Weinhouse GL, Brummel NE, Chlan LL, Cordoza M, Duby JJ, Gelinas C, Hall-Melnychuk EL, Krupp A, Louzon PR, Tate JA, Young B, Jennings R, Hines A, Ross C, Carayannopoulos KL, Aldrich JM. A Focused Update to the Clinical Practice Guidelines for the Prevention and Management of Pain, Anxiety, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2025 Mar 1;53(3):e711-e727. doi: 10.1097/CCM.0000000000006574. Epub 2025 Feb 21.

Reference Type BACKGROUND
PMID: 39982143 (View on PubMed)

Liu H, Zhang S, Zhang C, Gao Q, Liu Y, Liao F, Ge S. Risk factors for prolonged postoperative ICU stay in the patients with Stanford type A aortic dissection. J Cardiothorac Surg. 2024 Feb 3;19(1):46. doi: 10.1186/s13019-024-02548-7.

Reference Type BACKGROUND
PMID: 38310273 (View on PubMed)

Dumfarth J, Kofler M, Stastny L, Plaikner M, Krapf C, Semsroth S, Grimm M. Stroke after emergent surgery for acute type A aortic dissection: predictors, outcome and neurological recovery. Eur J Cardiothorac Surg. 2018 May 1;53(5):1013-1020. doi: 10.1093/ejcts/ezx465.

Reference Type BACKGROUND
PMID: 29360972 (View on PubMed)

Biancari F, Herve A, Peterss S, Radner C, Buech J, Pettinari M, Rodriguez Lega J, Pinto AG, Fiore A, Onorati F, Francica A, Wisniewski K, Demal T, Conradi L, Rocek J, Kacer P, Gatti G, Vendramin I, Rinaldi M, Ferrante L, Pruna-Guillen R, Quintana E, DI Perna D, Mariscalco G, Jormalainen M, Field M, Harky A, Dell'aquila AM, Juvonen T, Makikallio T, Perrotti A. Predictors, prognosis and costs of prolonged intensive care unit stay after surgery for type A aortic dissection. Minerva Anestesiol. 2024 Jul-Aug;90(7-8):654-661. doi: 10.23736/S0375-9393.24.18210-7.

Reference Type BACKGROUND
PMID: 39021141 (View on PubMed)

Arabi YM, Phua J, Koh Y, Du B, Faruq MO, Nishimura M, Fang WF, Gomersall C, Al Rahma HN, Tamim H, Al-Dorzi HM, Al-Hameed FM, Adhikari NK, Sadat M; Asian Critical Care Clinical Trials Group. Structure, Organization, and Delivery of Critical Care in Asian ICUs. Crit Care Med. 2016 Oct;44(10):e940-8. doi: 10.1097/CCM.0000000000001854.

Reference Type BACKGROUND
PMID: 27347762 (View on PubMed)

Other Identifiers

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CMUH114-REC1-139

Identifier Type: -

Identifier Source: org_study_id