Trial Outcomes & Findings for Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient (NCT NCT02168387)

Results Overview

An atelectasis score (AS), as published by Deakins, et al. 2002, was assigned to each radiograph as follows: 0 Complete resolution of collapse 1. Partial collapse of 1 segment or lobe 2. Partial collapse of ≥ 2 segments or lobes 3. Complete collapse of 1 segment or lobe 4. Complete collapse of ≥ 2 segments or lobes In the event of inter-rater disagreement, the scores were averaged. Improvement was defined as any decrease in AS ≥ 0.5. Worsening was defined as an increase in AS ≥ 0.5 or escalation of respiratory support modality (i.e. high frequency ventilation).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

after 48 hours of therapy

Results posted on

2015-03-03

Participant Flow

All mechanically ventilated patients 0-17 years of age admitted to the Pediatric Intensive Care Unit (PICU) and Pediatric Cardiac Intensive Care Unit (PCICU) from January 2011 to March 2012 with radiographic evidence of atelectasis for which mucolytics or CHFO therapy were being initiated by the patient care team were screened for enrollment.

Participant milestones

Participant milestones
Measure	Medication Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours. Acetylcysteine dornase alfa	Continuous High Frequency Oscillator (CHFO) Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours. continuous high frequency oscillator (CHFO)
Overall Study STARTED	20	19
Overall Study COMPLETED	13	16
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Medication Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours. Acetylcysteine dornase alfa	Continuous High Frequency Oscillator (CHFO) Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours. continuous high frequency oscillator (CHFO)
Overall Study Planned exubation	6	3
Overall Study Death	1	0

Baseline Characteristics

Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medication n=20 Participants Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.	Continuous High Frequency Oscillator (CHFO) n=19 Participants Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.	Total n=39 Participants Total of all reporting groups
Age, Customized less than or equal to 1 year	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants
Age, Customized greater than 1 year	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	19 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: after 48 hours of therapy

An atelectasis score (AS), as published by Deakins, et al. 2002, was assigned to each radiograph as follows: 0 Complete resolution of collapse 1. Partial collapse of 1 segment or lobe 2. Partial collapse of ≥ 2 segments or lobes 3. Complete collapse of 1 segment or lobe 4. Complete collapse of ≥ 2 segments or lobes In the event of inter-rater disagreement, the scores were averaged. Improvement was defined as any decrease in AS ≥ 0.5. Worsening was defined as an increase in AS ≥ 0.5 or escalation of respiratory support modality (i.e. high frequency ventilation).

Outcome measures

Outcome measures
Measure	Medication n=13 Participants Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.	Continuous High Frequency Oscillator (CHFO) n=16 Participants Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
Improvement of Atelectasis Improved in 48 h	6 participants	7 participants
Improvement of Atelectasis Worse in 48 hr	3 participants	6 participants
Improvement of Atelectasis No change in 48 hr	4 participants	3 participants

SECONDARY outcome

Timeframe: baseline and 48 hours

The deadspace-to-tidal volume (Vd/Vt) ratio is a parameter that is measured in mechanically ventilated patients as a way to assess the severity of gas exchange impairment and to assist in determining whether a patient is ready to be weaned from the ventilator. The change from baseline was measured at 48 hours, with a decreasing ratio indicating improvement.

Outcome measures

Outcome measures
Measure	Medication n=13 Participants Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.	Continuous High Frequency Oscillator (CHFO) n=16 Participants Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
Change in Capnography (Vd/Vt)	-0.04 ratio Standard Deviation 0.08	0.03 ratio Standard Deviation 0.09

SECONDARY outcome

Timeframe: baseline and 48 hours

Population: These data were not obtained due to technical difficulties.

Outcome measures

Outcome data not reported

Adverse Events

Medication

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Continuous High Frequency Oscillator (CHFO)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Medication n=20 participants at risk Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.	Continuous High Frequency Oscillator (CHFO) n=19 participants at risk Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
General disorders death due to underlying disease	5.0% 1/20 • Number of events 1	0.00% 0/19

Other adverse events

Adverse event data not reported

Additional Information

Ira M. Cheifetz, MD, FCCM, FAARC

Duke University Medical Center

Phone: 919-681-4080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place