Acupuncture to Improve Comfort of Children on a Ventilator in the Intensive Care Unit
Completed · Not applicable · Has a placebo group
Conditions studied: Agitation
In brief
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.
Key facts
- Study ID
- NCT01848158
- Run by
- Seattle Children's Hospital
- People needed
- 17
- Starts
- 2013-03-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2020-08-13
Who can join
Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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})
Where it is running
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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