NCT07167628

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

4.3 years

First QC Date

August 31, 2025

Last Update Submit

December 19, 2025

Conditions

Keywords

Acute type A aortic dissectionNeurological complicationsIntensive care unitICU workloadICU length of stayMechanical ventilationHospital length of stayRetrospective cohortNursing workloadTaiwan

Outcome Measures

Primary Outcomes (2)

  • Prolonged ICU length of stay (LOS ≥10 days)

    Proportion of participants with ICU LOS ≥10 days during the index ICU admission. Unit of measure: percent.

    Through ICU discharge during the index admission (up to 30 days).

  • Any postoperative neurological complication

    Proportion with stroke (CT/MRI confirmed), other focal neurological deficits, paraplegia, or sustained coma/encephalopathy recorded by neurology consultation. Unit of measure: percent.

    Through hospital discharge during the index admission (up to 30 days).

Secondary Outcomes (5)

  • ICU length of stay (days)

    Through ICU discharge during the index admission (up to 30 days).

  • Duration of mechanical ventilation (hours)

    Through final extubation during the index hospitalization (up to 40 days).

  • Hospital length of stay (days)

    Through hospital discharge during the index admission (up to 65 days).

  • In-hospital mortality

    Through hospital discharge during the index admission (up to 30 days).

  • In-hospital mortality within 30 days

    Up to 30 days after index surgery, during the index hospitalization.

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive adults undergoing emergency repair of acute type A aortic dissection at a single tertiary centre ICU in Taichung, Taiwan (2021-01-01 to 2025-04-30).

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taichung City, 40447, Taiwan

Location

Related Publications (10)

  • Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. PLoS Med. 2007 Oct 16;4(10):e297. doi: 10.1371/journal.pmed.0040297.

    PMID: 17941715BACKGROUND
  • 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.

    PMID: 22890468BACKGROUND
  • 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.

    PMID: 23652265BACKGROUND
  • 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.

    PMID: 22999497BACKGROUND
  • 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.

    PMID: 23431219BACKGROUND
  • 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.

    PMID: 39982143BACKGROUND
  • 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.

    PMID: 38310273BACKGROUND
  • 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.

    PMID: 29360972BACKGROUND
  • 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.

    PMID: 39021141BACKGROUND
  • 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.

    PMID: 27347762BACKGROUND

MeSH Terms

Conditions

Aortic DissectionStrokeParaplegiaAcute Kidney InjuryComaDelirium

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsConfusionNeurocognitive DisordersMental Disorders

Study Officials

  • En-Bo Wu, MD

    Department of Anesthesiology, China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2025

First Posted

September 11, 2025

Study Start

January 1, 2021

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. The dataset consists of de-identified electronic health records governed by CMUH institutional policy and IRB approval (CMUH114-REC1-139), which restrict external transfer. Aggregate results or summary tables may be provided on reasonable request, subject to additional REC approval and data-use agreements.

Locations