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The Effectiveness of Acupuncture for Delirium in Critically Ill Patients

NCT04312893 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-08-03

No results posted yet for this study

Summary

Introduction: Intensive care unit (ICU) delirium is an acute onset of brain dysfunction, which can affect 25-80% of ICU patients. Delirium is also associated with long term cognition impairment, higher mortality and higher ICU costs. Previous acupuncture studies showed the potential to prevent delirium. This study will examine the ability of acupuncture to treat ICU delirium.

Methods: A double-blind randomized control trial will examine the effect of press tack acupuncture vs. press tack placebos. The patients will be randomly divided (1:1) into one of two groups. A total of 80 ICU patient will have to meet the following criteria: age 20-90, APACHE score \<30, Intensive Care Delirium Screening Checklist (ICDSC) \>4 points (indicates existing delirium), Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4, -1, -2. Three interventions will be given in each group. The main outcomes will be the delirium days according to the ICDSC.

Conditions

  • Intensive Care Unit Delirium
  • Delirium
  • Agitation

Interventions

OTHER

Acupuncture (Press Tack Needle)

Press Tack Needle (PYONEX made by Seirin Corporation). The needles appear identical to the press tack placebo with the only different is the needle itself which was removed in the placebo needles.

OTHER

press tack placebo

press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element.

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-12
Primary Completion
2022-05-30
Completion
2022-05-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04312893 on ClinicalTrials.gov