Low-Intensity Monitoring Nursing After Thrombolysis for Acute Ischemic Stroke

NCT07865598 — Not applicable, Not yet recruiting, 864 participants, Shengjing Hospital

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Effect of Low-Intensity Monitoring Frequency After Intravenous Thrombolysis for Acute Ischemic Stroke on Nursing Workload and Missed Nursing Care: A Multicenter, Open-Label, Randomized, Blinded-Endpoint Trial

Registry	NCT07865598, acronym OPTINursing
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	864 (Estimated)
Sponsor	Shengjing Hospital (Other)
Conditions	Stroke, Ischemic
Interventions	lower frequency of assessment of neurological impairment and vital signs, standard frequency of assessment of neurological impairment and vital signs (Procedure)
Dates	start 2026-12-01 (estimated), primary completion 2028-03-31 (estimated), completion 2028-03-31 (estimated), first posted 2026-10-08, last updated 2026-10-08

-Summary

This cluster-randomized study compares a lower-frequency post-thrombolysis monitoring pathway with a standard pathway in adults with acute ischemic stroke. The study evaluates nursing workload, nursing care, and clinical safety during the early post-thrombolysis period.

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+Detailed description

Intravenous thrombolysis is an established reperfusion treatment for eligible patients with acute ischemic stroke, but post-thrombolysis monitoring is resource intensive. This study will evaluate whether a lower scheduled monitoring frequency can reduce nursing workload without causing a clinically important increase in missed nursing care or compromising clinical safety. Hospitals will be randomized in a 1:1 ratio to a low-intensity monitoring pathway or a standard-intensity monitoring pathway.

+Arms and interventions

Arm	Type	Interventions	Description
Low-Intensity Monitoring	Experimental	Procedure: lower frequency of assessment of neurological impairment and vital signs	Participants at assigned hospitals will receive a reduced scheduled nursing monitoring pathway during the first 24 hours after intravenous thrombolysis. Additional assessment or clinical escalation is permitted when indicated.
Standard Monitoring	Active comparator	Procedure: standard frequency of assessment of neurological impairment and vital signs	Participants at assigned hospitals will receive the study standard scheduled nursing monitoring pathway during the first 24 hours after intravenous thrombolysis. Additional assessment or clinical escalation is permitted when indicated.

lower frequency of assessment of neurological impairment and vital signs (Procedure): Participants receive neurological assessment and heart rate/blood pressure assessment every 15 minutes during the first 2 hours after initiation of thrombolytic infusion, every 2 hours during the next 8 hours, and every 4 hours during the subsequent 14 hours. Additional clinically indicated monitoring is permitted and required.
standard frequency of assessment of neurological impairment and vital signs (Procedure): Participants receive neurological assessment and heart rate/blood pressure assessment every 15 minutes during the first 2 hours after initiation of thrombolytic infusion, every 30 minutes during the subsequent 6 hours, and every 60 minutes during the subsequent 16 hours. Additional clinically indicated monitoring is permitted and required.

+Outcome measures

Primary outcomes

Objective Nursing Workload [From baseline to 24 hours: total time spent on post-thrombolysis nursing monitoring activities, recorded in minutes per participant.]

Secondary outcomes

Missed Nursing Care [During index hospitalization, up to 7 days, using MISSCARE Survey.]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Adults aged 18 years or older;
2. diagnosis of acute ischemic stroke;
3. treatment with intravenous alteplase, tenecteplase, or an equivalent thrombolytic agent as part of clinical care;
4. stable vital signs with blood pressure no higher than 180/105 mmHg;
5. and mild-to-moderate neurological deficit assessed by a clinician 2 hours after thrombolysis, for example NIHSS less than 10.

Exclusion Criteria:

1. A clear clinical contraindication to low-intensity monitoring, including need for intensive care or prolonged intensive monitoring, severe neurological deficit, early neurological deterioration or substantial risk of deterioration, need for airway support, or need for intravenous treatment unavailable on a general ward;
2. or anticipated immediate transfer, dialysis-related transfer, palliative management, or surgery that is incompatible with adherence to the low-intensity monitoring pathway.