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Completed

NCT Number: NCT01362270

Acupuncture for Sedation in the Intensive Care Unit (ICU)

BACKGROUND Many patients in the trauma intensive care unit (TICU) require mechanical ventilation and sedation or anxiolysis. Mechanical ventilation means that a machine is helping a patient breathe if he can't breathe on his own. Because of the mechanical ventilation, these patients also require some medication to help keep them calm. These are called sedatives or anxiolytics.

The purpose of this study is to see if acupuncture can lower the amount of sedation and anxiolysis needed by a subject during mechanical ventilation in the TICU. Acupuncture is a medical procedure. Hair-thin sterile needles are inserted at specific points on the body.

PROCEDURES Some subjects will get acupuncture and others will get 'fake' acupuncture. By using 'fake' acupuncture, no one other than the acupuncturists will know which group a subject is in. Subjects and the team do not get to pick which subject is in which group. Instead, the groups are picked randomly. Subjects will get real or fake acupuncture twice a day for five days.

Standard of care - Both groups will receive the standard of care while in the study. They will be mechanically ventilated and given sedatives and analgesics based on the TICU protocol.

Real acupuncture group - This group will receive real acupuncture with real needles. These are stainless steel, one time use, needles. This group will also receive "ear tacks" which are like little needles that can stay on the ear for a few days. The ear tacks will be covered with a bandage so no one can tell which group the subject is in.

Sham acupuncture group - This group will receive sham needles. These needles retract into themselves much like a 'magic sword' rather than poking the skin. Subjects in this group will not get ear tacks. In order to hide the group the subject is in, a bandage will be used to cover part of the ear.

HYPOTHESIS Real acupuncture will decrease subject's sedation requirements by 30% when compared to the sham acupuncture group.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Overmedication Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Depression Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Trauma patient ≥ 18 years admitted to the Trauma ICU
  • Injury Severity Score (ISS) ≥ 4
  • Mechanically ventilated < 24 hours with anticipated need > 24 hours

Exclusion criteria

  • Inability to obtain consent from patient or designee
  • Receiving immunosuppressive therapy
  • Receiving therapeutic anticoagulant therapy
  • History of bleeding disorder, INR > 1.5, PTT > 65, PLT < 20K
  • Pregnancy
  • Three (3) or more inaccessible acupoints
  • Head injury with elevated intracranial pressure or requiring operation
  • Patients with midline abdominal incision
  • Non-english speaking
  • Receipt of dexmedetomidine prior to or during study period

Treatment and study plan

Verum acupuncture

Device

DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days

Other names: Special No. 16 needles (Gauge 8 x 1.2")

Sham acupuncture

Device

DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days

Other names: Streitberger Placebo-needles (Gauge 8 x 1.2")

Primary outcomes

  1. Success of Blinding

    Time frame: Nurse surveyed daily for length of study (five [5] days). Physician and subject (or subject's family if he/she is unable to complete the questionnaire) surveyed upon study completion, six (6) days after enrollment.

    Care team, family and subject will be surveyed to determine success of blinding. Responses will be tallied and correlated with group assignments.

Secondary outcomes

  1. Richmond Agitation-Sedation Scale (RAAS) Score

    Time frame: Median RAAS score during treatment (5 days)

    Measure of sedation. Scale -5 to +4, with -5 equal to 'Unarousable' and +4 equal to 'Combative.'

  2. Length of Ventilator Dependence

    Time frame: Number hourss subject is ventilated. Subjects are expected to be ventilator dependent an average of 120 hours. Assessed up to discharge (estimated 3 weeks).

    Number of hours of ventilator use

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Medical Research Foundation, Oregon

Registry information

Official study title

Acupuncture for Sedation in the Intensive Care Unit

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 30, 2011
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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