Trial Outcomes & Findings for Acupuncture to Improve Comfort of Children on a Ventilator in the Intensive Care Unit (NCT NCT01848158)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

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

Results posted on

2020-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Acupuncture Acupuncture treatment three times per week for up to two weeks. acupuncture: 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.	Sham Acupuncture Sham acupuncture three times per week for up to two weeks sham acupuncture: 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.
Overall Study STARTED	10	7
Overall Study COMPLETED	10	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acupuncture n=10 Participants Acupuncture treatment three times per week for up to two weeks. acupuncture: 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.	Sham Acupuncture n=7 Participants Sham acupuncture three times per week for up to two weeks sham acupuncture: 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.	Total n=17 Participants Total of all reporting groups
Age, Continuous	2.4 years n=5 Participants	1.0 years n=7 Participants	1.7 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants
PRISM III	0 units on a scale n=5 Participants	3 units on a scale n=7 Participants	0 units on a scale n=5 Participants

PRIMARY outcome

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

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).

Outcome measures

Outcome measures
Measure	Acupuncture n=10 Participants Acupuncture treatment three times per week for up to two weeks. acupuncture: 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.	Sham Acupuncture n=7 Participants Sham acupuncture three times per week for up to two weeks sham acupuncture: 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.
Average Daily Dexmedetomidine mcg/kg/Day	11.08 mcg/kg/day Standard Deviation 9.37	17.42 mcg/kg/day Standard Deviation 6.36

PRIMARY outcome

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

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).

Outcome measures

Outcome measures
Measure	Acupuncture n=10 Participants Acupuncture treatment three times per week for up to two weeks. acupuncture: 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.	Sham Acupuncture n=7 Participants Sham acupuncture three times per week for up to two weeks sham acupuncture: 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.
Average Daily Morphine Equivalents (mg/kg/Day)	1.04 mg/kg/day Standard Deviation 0.68	1.61 mg/kg/day Standard Deviation 1.12

PRIMARY outcome

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

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).

Outcome measures

Outcome measures
Measure	Acupuncture n=10 Participants Acupuncture treatment three times per week for up to two weeks. acupuncture: 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.	Sham Acupuncture n=7 Participants Sham acupuncture three times per week for up to two weeks sham acupuncture: 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.
Average Daily Midazolam Equivalents (mg/kg/Day)	0.73 mg/kg/day Standard Deviation 1.03	0.97 mg/kg/day Standard Deviation 0.80

PRIMARY outcome

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

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).