Acupuncture to Improve Comfort of Children on a Ventilator in the Intensive Care Unit

NCT01848158 | Completed Results DMC

• 1 other identifier: 24849 Academic Enrichment Fund
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitation

Keywords

acupuncture; pediatric; critical care; mechanical ventilation; sedation; comfort

Outcome Measures

Primary Outcomes (4)

• Average Daily Dexmedetomidine mcg/kg/Day

  Measured total amount of dexmedetomidine received from time of first acupuncture or sham treatment to extubation, normalized per weight and time on study (1st study treatment to extubation).

  from time of first acupuncture/sham treatment till time of extubation

• Average Daily Morphine Equivalents (mg/kg/Day)

  Measured total amount of morphine equivalent received from time of first acupuncture or sham treatment to extubation, normalized per weight and time on study (1st study treatment to extubation).

  from time of first acupuncture/sham treatment till time of extubation

• Average Daily Midazolam Equivalents (mg/kg/Day)

  Measured total amount of midazolam equivalent received from time of first acupuncture or sham treatment to extubation, normalized per weight and time on study (1st study treatment to extubation).

  from time of first acupuncture/sham treatment till time of extubation

• Average Daily Sedation Score

  To capture a global view of sedation and account for the combination of medications received, we also calculated an average daily 'sedation score' normalized for weight from the time of first treatment through extubation. The sedation score is a summary measure of sedative and analgesic exposure for mechanically ventilated children in the ICU. This score incorporates opioids, benzodiazepines, barbiturates, chloral hydrate, propofol, and antihistamines. Morphine and midazolam equivalents of 0.1 mg/kg, pentobarbital 2 mg/kg, chloral hydrate 50 mg/kg, any propofol use, and any phenobarbitol use are each allocated one point, while any antihistamine use receives a score of 0.5 (Randolph 2002, Curley 2005). We modified this score to include dexmedetomidine, assigning 1 point for 1 μg/kg of dexmedetomidine. The minimum value possible is zero, and there is no pre-defined maximum value. A higher score indicates higher dose of sedation medications (normalized by weight).

  from time of first acupuncture/sham treatment till time of extubation

Secondary Outcomes (6)

• Number of Participants With Skin Ulceration at Acupuncture/Sham Sites

  From time of first treatment through 2 to 3 days after last treatment.

• Number of Participants With Hematoma at Acupuncture/Sham Sites

  From time of first treatment through 2 to 3 days after last treatment.

• Number of Participants With Cellulitis at Acupuncture/Sham Sites

  From time of first treatment through 2 to 3 days after last treatment.

• Number of Participants Who Are Diagnosed With Bacteremia During the Study

  From time of first treatment through 2 to 3 days after last treatment.

• Number of Participants Who Are Diagnosed With Septic Shock During the Study

  From time of first treatment through 2 to 3 days after last treatment.

Study Arms (2)

Acupuncture

EXPERIMENTAL

Acupuncture treatment three times per week for up to two weeks.

Device: acupuncture

Sham Acupuncture

SHAM COMPARATOR

Sham acupuncture three times per week for up to two weeks

Device: sham acupuncture

Interventions

acupuncture DEVICE

Patients randomized to active treatment will receive acupuncture treatment with press needles (small acupuncture needles manufactured with attached bandage that makes the needle flush with skin) at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a seed magnet at ear shen men position for 4 hours on treatment days.

Also known as: Pyonex Singles, Seirin® (0.20 mm diameter, 1.5 mm long)

Acupuncture

sham acupuncture DEVICE

Patients randomized to sham treatment will receive sham acupuncture with similarly appearing bandages placed without press needles attached at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a similarly appearing bandage without seed magnet underneath at ear shen men position for 4 hours on treatment days.

Also known as: Pyonex Singles, Seirin® (bandage only, no needle)

Sham Acupuncture

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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})

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Kudchadkar SR, Berger J, Patel R, Barnes S, Twose C, Walker T, Mitchell R, Song J, Anton B, Punjabi NM. Non-pharmacological interventions for sleep promotion in hospitalized children. Cochrane Database Syst Rev. 2022 Jun 15;6(6):CD012908. doi: 10.1002/14651858.CD012908.pub2.

  PMID: 35703367 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Jane Di Gennaro, MD MS
• Organization: Seattle Children's Hospital

jane.digennaro@seattlechildrens.org

206-987-6988

Study Officials

• Jane L Di Gennaro, MD, MS

  Seattle Children's Hopsital

  PRINCIPAL INVESTIGATOR

• Anne Lynn, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jane L. Di Gennaro, MD, Assistant Professor

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 7, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 13, 2020
• Results First Posted: August 13, 2020

Record last verified: 2020-08

Locations

US (1)