Low-Intensity Monitoring Nursing After Thrombolysis for Acute Ischemic Stroke
ConditionStroke, Ischemic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShengjing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older;
diagnosis of acute ischemic stroke;
treatment with intravenous alteplase, tenecteplase, or an equivalent thrombolytic agent as part of clinical care;
stable vital signs with blood pressure no higher than 180/105 mmHg;
Disqualifiers
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;
or anticipated immediate transfer, dialysis-related transfer, palliative management, or surgery that is incompatible with adherence to the low-intensity monitoring pathway.
Trial design
Design model
Parallel
Treatments tested in this trial
lower frequency of assessment of neurological impairment and vital signs
Procedure/SurgeryParticipants 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/SurgeryParticipants 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.
Treatment groups
864 Participants
are divided into 2 treatment groupsGroup A: Low-Intensity MonitoringExperimental treatment 1 intervention
Group B: Standard MonitoringActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Objective Nursing Workload
Time frame
From baseline to 24 hours: total time spent on post-thrombolysis nursing monitoring activities, recorded in minutes per participant.Secondary outcomes
1
Missed Nursing Care
Time frame
During index hospitalization, up to 7 days, using MISSCARE Survey.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: