Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety, Feasibility & Effectiveness of Acupuncture as an Adjunct to Pharmacologic Treatment for Sedation and Analgesia in Mechanically Ventilated PICU Patients - A Pilot Study
Brief Summary: The purpose of this study is to determine whether acupuncture is effective at improving comfort in children on a ventilator in the intensive care unit. Our hypothesis is that the patients receiving acupuncture will require less medications to keep them comfortable than those who receive sham or fake acupuncture.


Options:
A: Inclusion Criteria:

* PICU patient at Oishei Children's Hospital of Buffalo
* \>4 years of age, \<18 years of age
* Patients with RASS of +1

Exclusion Criteria:

* Documented underlying psychological disorders
* Diagnosed with sever developmental delay
* Prior narcotic dependence
* Underlying medical conditions affecting heart rate, blood pressure, or neuromuscular system
* Chemically paralyzed patients
* Anyone with an aneurysm
* Patients who are deaf in both ears
* Ear bone fractures or other middle/inner ear trauma or major ear avulsion as determined by physician
* Hemodynamically unstable patients
* Patients facing imminent death
B: Inclusion Criteria:

* Child aged 6-17 admitted to the PICU of one Canadian, university teaching hospital
* Child in age-appropriate grade at school (+- 1 year)
* Child can read and speak English or French
* Parent or primary caregiver willing to participate in the intervention, who can read, speak and write English or French

Exclusion Criteria:

* Child diagnosed with a sleep disorder, seizure disorder, hearing disorder, or who has had neurological surgery that precludes sleep measurement
* Child expected to die during their PICU stay
C: Inclusion Criteria:

* ICU-patients \>18 yrs old
* expected duration of stay \> 24 hrs

Exclusion Criteria:

* life expectancy of \<48 hrs on ICU admission
* necessity of prolonged deep sedation
* blindness
* inability to speak or understand dutch
D: Inclusion Criteria:

* age ≥6 months to \<18 years
* intubated and mechanically ventilated
* patient requires pharmacologic sedation/analgesia to tolerate mechanical ventilation
* ≤72 hours of mechanical ventilation at time of enrollment with anticipated need of mechanical ventilation for at least ≥48 hours more (in order to be able to receive at least one acupuncture session)
* approval of treating physician

Exclusion Criteria:

* underlying neurologic condition that could impact sedation/analgesia needs
* coagulopathy (inr ≥ 1.8) or history of spontaneous bruising
* thrombocytopenia (platelets \<20,000 that has not been treated with a platelet transfusion)
* hemodynamic instability (on continuous infusion of vasopressor or inotrope)
* sepsis or bacteremia on antibiotic therapy \<24 hours
* severe generalized skin disorder (e.g., epidermolysis bullosa, Stevens-Johnson)
* ward of state
* being treated with therapeutic level of systemic anticoagulation (e.g., heparin with unfractionated heparin activity level ≥0.3, enoxaparin with low molecular weight heparin activity level ≥0.5, warfarin with inr ≥1.8)
* immunosuppressed (on chemotherapy {e.g., daunorubicin, vincristine}, immunosuppressive medications {e.g., sirolimus, tacrolimus, cyclosporine, mycophenolate mofetil, high dose steroids \>4mg/kg/day}, or immunosuppressive biologics {e.g., thymoglobulin, etanercept, infliximab, adalimumab, rituximab})

Answer: D