DeliriumNCT04950738
The Effectiveness of Acupuncture for Complications in Critically Ill Patients
A study testing pess tack acupuncture in people with Delirium and Agitation, run by China Medical University Hospital.
Trial summary
Introduction: Intensive care unit (ICU) is a special department in the health care facility. Although with high development of modern medicine nowadays, the average mortality rate in ICU is still around 7 to 20 %. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Delirium, Agitation, Arrhythmia
- What is being tested?
- pess tack acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20--90
- newly ICU admission (<48 hours)
- APACHE score <30
- Less than 3 inotropic medicine use
- Fi02< 60%.
Who cannot join
- • Coagulopathy: Prolong Prothrombin Time (PPT) activated Partial Thromboplastin Time (aPTT) more than 4 times
- Thrombocytopenia - low platelet count
- Clinically unstable: receiving two or more inotropic agents or Fraction of Inspired Oxygen (Fi02) >60%
- Primary central nervous system disorder: stroke, traumatic brain injury, central nervous system infections, brain tumors, recent intracranial surgery
- Already under other traditional medicine intervention during hospitalization
- Skin damage of more than 20% of the body skin.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness of Acupuncture for Complications in Critically Ill Patients: Multiple Centers a Double-Blind Randomized Control Trial
Introduction:
Intensive care unit (ICU) is a special department in the health care facility. Although with high development of modern medicine nowadays, the average mortality rate in ICU is still around 7 to 20 %. There are a few tricky problems that intensivists and ICU nurses faced very often, including ICU delirium, arrhythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients.
Methods: A 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 patients will have to meet the following criteria: age 20-90, newly ICU admission(<48 hours), APACHE score <30, one or no inotropic medicine use, FiO2< 60%. Three interventions will be given in each group. The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain. We will also record ICU mortality, ICU stays and hospital days.
Read the detailed description
Introduction:
Intensive care unit (ICU) is a special department in the health care facility. Although with high development of modern medicine nowadays, the average mortality rate in ICU is still around 7 to 20 %. There are a few tricky problems that intensivists and ICU nurses faced very often, including ICU delirium, arrhythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients.
Methods: A 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 patients will have to meet the following criteria: age 20-90, newly ICU admission(<48 hours), APACHE score <30, one or no inotropic medicine use, FiO2< 60%. Three interventions will be given in each group. The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain. We will also record ICU mortality, ICU stays and hospital days.
Expected outcome: The study finding will help to determine the therapeutic effect of acupuncture for ICU complications.
Other information: This study will be conducted in the ICU departments of China medical hospital and Asia University Hospital, Taichung city, Taiwan. The study is conducted on stable ICU patients and we don't anticipate any serious risk for adverse events following the intervention.
- Conditions
- Delirium, Agitation, Arrhythmia, Feeding Intolerance, Pain, Acute
- Being tested
- pess tack acupuncture, pess tack placebo
- Keywords
- acupuncture, intensive care, delirium, agitation, double blinded randomized control study
- Medical subject headings
- Delirium, Psychomotor Agitation, Arrhythmias, Cardiac, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pess tack acupunctureOther
Also called Press Tack Needle/ sticker needle/ PYONEX
Patients enrolled will receive intervention in a form of either press tack acupuncture needles or press tack placebos. Three total intervention sessions will be taken place on day 1,3,5 from patient's enrolment. Needles/placebos skin withdrawal will be done 48 hours after treatment by an acupuncture doctor or by a trained ICU nurne. In cases when a patient will be transferred from the ICU, the 3 study interventions will be continued in the new ward.
pess tack placeboOther
Also called PYONEX placebo
pess tack stickers without a needle
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture with press tack needle group (Acu) | Experimental | Patients in acupuncture group will receive traditional Chinese acupuncture using Press Tack Needle (PYONEX 0.20 x l.5mm made by Seirin Corporation). The following acupoints will be used: HT 7 (Shen Men), PC 6 (Nei Guan), LU 9 (Tai yuan), LI 4 (He Gu), SP 3 (Tai Bai,) ST 44 (Nei ting), LIV 3 (Tai Chong). The treatment will use bilateral acupuncture Interventions will be given on day 1, 3, and 5 after patient's enrolment. Receives: Other: pess tack acupuncture |
| Placebo group press tack placebo (Con) | Placebo comparator | Patients randomized to the control group will receive a press lack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element. The point selection will be identical to the acupuncture group: HT 7 (Shen Men), PC 6 (Nei Guan), LU 9 (Tai yuan), L1 4 (He Gu), SP 3; (Tat Bai), ST 44 (Ne1 tmg), LIV 3 (Tat Chong). Interventions will be given on days 1, 3, and 5 after the patient's enrolment. Receives: Other: pess tack placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
arrhythmia
incidence of arrhythmia
Measured: at the patient's ICU discharge, on average 1 week
delirium
4 or more points according to the Intensive Care Delirium Screening Checklist (ICDSC)(0-8 scale, score of less than 4 points indicate no delirium, 4 or more indicate delirium) and a Richmond Agitation-Sedation Scale (RASS) score of: +l, +2, +3, +4 - 1, -2 (score meanings +1 - 4 = levels of agitation, -1-4= levels of sudation, 0 = normal mental state.
Measured: at the patient's ICU discharge, on average 1 week
feeding intolorance
measured by days to reach the target Energy Fxpenditure
Measured: at the patient's ICU discharge, on average 1 week
pain in the intensive care unit (ICU)
For pain the Numeric Rating scale will be applied in patients that are able to express their self. As well as the Behavioral pain scale. The Critical Care Pain Observation Tool (CPOT) 0-8, will also be filled by the doctor and nurses along with the dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications.
Measured: at the patient's ICU discharge, on average 1 week
dose of arrhythmia drugs
the dose of Adenosine, calcium channel blockers, or beta-blocking agents or other arrhythmia drugs
.
Measured: at the patient's ICU discharge, on average 1 week
dose of use of prokinetic drugs
does of metoclopramide, Erythromycin or other prokinetic drugs
Measured: at the patient's ICU discharge, on average 1 week
analgesic medication use
dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications.
Measured: at the patient's ICU discharge, on average 1 week
delirium drug use
addition to drug use (a daily dose of sedative drugs, muscle relaxant, or atypical antipsychotics IV Haloperidol Benzodiazepines, Precedex, Propofol and oral Quediapine)
Measured: at the patient's ICU discharge, on average 1 week
Secondary outcomes (24)
the use of Parental nutrition
patients who cannot digest with daily NG tube: drainage: more than 500ml per day or severe diarrhea more the 1000 ml per day
Measured: at the patient's ICU discharge, on average 1 week
the need for a post-pyloric tube
patients who cannot digest with daily NG tube and by doctor decision
Measured: at the patient's ICU discharge, on average 1 week
vomitus
in microliters
Measured: at the patient's ICU discharge, on average 1 week
diarrhea
in microliters
Measured: at the patient's ICU discharge, on average 1 week
constipation days
3 days without stool discharge
Measured: at the patient's ICU discharge, on average 1 week
gastrointestinal (GI) bleeding
in number of times
Measured: at the patient's ICU discharge, on average 1 week
albumin blood levels
serum albumin blood levels
Measured: at the patient's ICU discharge, on average 1 week
Intravenous (IV) injected albumin
IV injected albumin in grams
Measured: at the patient's ICU discharge, on average 1 week
heart rate
number of beats per minute
Measured: day 1,3,5,7
blood pressure
systolic and diastolic blood pressure in mm Hg
Measured: day 1,3,5,7
SpO2 oxygen saturation
Sp02 oxygen saturation levels
Measured: day 1,3,5,7
Respiratory rate
measured by number of breath in one minute
Measured: day 1,3,5,7
mean arterial pressure
average pressure in a patient's arteries during one cardiac cycle
Measured: day 1,3,5,7
Body temperature
number of days of body temperature over 38 °C
Measured: at the patient's ICU discharge, on average 1 week
ventilator data
ventilator data
Measured: day 1,3,5,7
Overall Satisfaction of patient family
Overall Satisfaction of patient family will be measured by the European Family Satisfaction with Care in the Intensive Care Unit (EURO FS-ICU).
Measured: at the patient Hospital discharge, on average 1 month
mechanical ventilation days days
number of days under mechanical ventilation
Measured: at the patient Hospital discharge, on average 1 month
ICU stay
number of admission days to the ICU
Measured: at the patient's ICU discharge, on average 1 week
hospital days
number of admission days to the hospital
Measured: at the patient Hospital discharge, on average 1 month
ICU mortality
number of patients died in the ICU
Measured: at the patient's ICU discharge, on average 1 week
Hospital mortality
number of patients died in the hospital
Measured: at the patient Hospital discharge, on average 1 month
cost of hospital admission
cost of hospital admission in New Taiwan Dollars {TWD)
Measured: at the patient Hospital discharge, on average 1 month
cost of ICU admission
cost of ICU admission in New Taiwan Dollars {TWD).
Measured: at the patient's ICU discharge, on average 1 week
acupuncturist blinding
blinding questioner will ask the acupuncturist to which group he/she guessed he/she applied the intervention
Measured: after intervention on day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter parallel arm double-blind randomized control trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chen Lee, China Medical University Hospital
- Investigators
- Yu-Chen Lee, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950738
- Sponsor's protocol ID
- CMUH110-REC1-037
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Acupuncture for Complications in Critically Ill Patients: Multiple Centers a Double-Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04950738
- Acronym / sponsor ID
- CMUH110-REC1-037
- Conditions
- Delirium, Agitation, Arrhythmia, Feeding Intolerance, Pain, Acute
- Keywords
- acupuncture, intensive care, delirium, agitation, double blinded randomized control study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction:
Intensive care unit (ICU) is a special department in the health care facility. Although with high development of modern medicine nowadays, the average mortality rate in ICU is still around 7 to 20 %. There are a few tricky problems that intensivists and ICU nurses faced very often, including ICU delirium, arrhythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients.
Methods: A 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 patients will have to meet the following criteria: age 20-90, newly ICU admission(<48 hours), APACHE score <30, one or no inotropic medicine use, FiO2< 60%. Three interventions will be given in each group. The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain. We will also record ICU mortality, ICU stays and hospital days.
Detailed description
Introduction:
Intensive care unit (ICU) is a special department in the health care facility. Although with high development of modern medicine nowadays, the average mortality rate in ICU is still around 7 to 20 %. There are a few tricky problems that intensivists and ICU nurses faced very often, including ICU delirium, arrhythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients.
Methods: A 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 patients will have to meet the following criteria: age 20-90, newly ICU admission(<48 hours), APACHE score <30, one or no inotropic medicine use, FiO2< 60%. Three interventions will be given in each group. The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain. We will also record ICU mortality, ICU stays and hospital days.
Expected outcome: The study finding will help to determine the therapeutic effect of acupuncture for ICU complications.
Other information: This study will be conducted in the ICU departments of China medical hospital and Asia University Hospital, Taichung city, Taiwan. The study is conducted on stable ICU patients and we don't anticipate any serious risk for adverse events following the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multicenter parallel arm double-blind randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Acupuncture with press tack needle group (Acu) | Experimental | Other: pess tack acupuncturePatients in acupuncture group will receive traditional Chinese acupuncture using Press Tack Needle (PYONEX 0.20 x l.5mm made by Seirin Corporation). The following acupoints will be used: HT 7 (Shen Men), PC 6 (Nei Guan), LU 9 (Tai yuan), LI 4 (He Gu), SP 3 (Tai Bai,) ST 44 (Nei ting), LIV 3 (Tai Chong). The treatment will use bilateral acupuncture Interventions will be given on day 1, 3, and 5 after patient's enrolment. |
| Placebo group press tack placebo (Con) | Placebo comparator | Other: pess tack placeboPatients randomized to the control group will receive a press lack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element. The point selection will be identical to the acupuncture group: HT 7 (Shen Men), PC 6 (Nei Guan), LU 9 (Tai yuan), L1 4 (He Gu), SP 3; (Tat Bai), ST 44 (Ne1 tmg), LIV 3 (Tat Chong). Interventions will be given on days 1, 3, and 5 after the patient's enrolment. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20--90
Key exclusion criteria (6 listed)
- • Coagulopathy: Prolong Prothrombin Time (PPT) activated Partial Thromboplastin Time (aPTT) more than 4 times
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pess tack acupunctureAlso: Press Tack Needle/ sticker needle/ PYONEXPatients enrolled will receive intervention in a form of either press tack acupuncture needles or press tack placebos. Three total intervention sessions will be taken place on day 1,3,5 from patient's enrolment. Needles/placebos skin withdrawal will be done 48 hours after treatment by an acupuncture doctor or by a trained ICU nurne. In cases when a patient will be transferred from the ICU, the 3 study interventions will be continued in the new ward. | Other | Acupuncture with press tack needle group (Acu) |
| pess tack placeboAlso: PYONEX placebopess tack stickers without a needle | Other | Placebo group press tack placebo (Con) |
Primary outcome
arrhythmia
Time frame: at the patient's ICU discharge, on average 1 week
incidence of arrhythmia
delirium
Time frame: at the patient's ICU discharge, on average 1 week
4 or more points according to the Intensive Care Delirium Screening Checklist (ICDSC)(0-8 scale, score of less than 4 points indicate no delirium, 4 or more indicate delirium) and a Richmond Agitation-Sedation Scale (RASS) score of: +l, +2, +3, +4 - 1, -2 (score meanings +1 - 4 = levels of agitation, -1-4= levels of sudation, 0 = normal mental state.
feeding intolorance
Time frame: at the patient's ICU discharge, on average 1 week
measured by days to reach the target Energy Fxpenditure
pain in the intensive care unit (ICU)
Time frame: at the patient's ICU discharge, on average 1 week
For pain the Numeric Rating scale will be applied in patients that are able to express their self. As well as the Behavioral pain scale. The Critical Care Pain Observation Tool (CPOT) 0-8, will also be filled by the doctor and nurses along with the dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications.
dose of arrhythmia drugs
Time frame: at the patient's ICU discharge, on average 1 week
the dose of Adenosine, calcium channel blockers, or beta-blocking agents or other arrhythmia drugs .
dose of use of prokinetic drugs
Time frame: at the patient's ICU discharge, on average 1 week
does of metoclopramide, Erythromycin or other prokinetic drugs
analgesic medication use
Time frame: at the patient's ICU discharge, on average 1 week
dose of fentanyl, hydromorphone methadone, morphine, and remifentanil and other analgesic medications.
delirium drug use
Time frame: at the patient's ICU discharge, on average 1 week
addition to drug use (a daily dose of sedative drugs, muscle relaxant, or atypical antipsychotics IV Haloperidol Benzodiazepines, Precedex, Propofol and oral Quediapine)
24 secondary outcomes
the use of Parental nutrition
Time frame: at the patient's ICU discharge, on average 1 week
the need for a post-pyloric tube
Time frame: at the patient's ICU discharge, on average 1 week
vomitus
Time frame: at the patient's ICU discharge, on average 1 week
diarrhea
Time frame: at the patient's ICU discharge, on average 1 week
constipation days
Time frame: at the patient's ICU discharge, on average 1 week
gastrointestinal (GI) bleeding
Time frame: at the patient's ICU discharge, on average 1 week
albumin blood levels
Time frame: at the patient's ICU discharge, on average 1 week
Intravenous (IV) injected albumin
Time frame: at the patient's ICU discharge, on average 1 week
heart rate
Time frame: day 1,3,5,7
blood pressure
Time frame: day 1,3,5,7
SpO2 oxygen saturation
Time frame: day 1,3,5,7
Respiratory rate
Time frame: day 1,3,5,7
mean arterial pressure
Time frame: day 1,3,5,7
Body temperature
Time frame: at the patient's ICU discharge, on average 1 week
ventilator data
Time frame: day 1,3,5,7
Overall Satisfaction of patient family
Time frame: at the patient Hospital discharge, on average 1 month
mechanical ventilation days days
Time frame: at the patient Hospital discharge, on average 1 month
ICU stay
Time frame: at the patient's ICU discharge, on average 1 week
hospital days
Time frame: at the patient Hospital discharge, on average 1 month
ICU mortality
Time frame: at the patient's ICU discharge, on average 1 week
Hospital mortality
Time frame: at the patient Hospital discharge, on average 1 month
cost of hospital admission
Time frame: at the patient Hospital discharge, on average 1 month
cost of ICU admission
Time frame: at the patient's ICU discharge, on average 1 week
acupuncturist blinding
Time frame: after intervention on day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chen Lee principal investigator
China Medical University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing pess tack acupuncture in people with Delirium and Agitation, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chen Lee (04-22052121, d5167@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arrhythmia (time frame: at the patient's ICU discharge, on average 1 week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.