Trial Outcomes & Findings for Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation (NCT NCT01151618)

Results Overview

Expiratory flow limitation (EFL) is an increase in transpulmonary pressure (cmH2O) with no change expiratory flow (lpm). Expiratory Flow Limitation or absence thereof will be detected by using a measurement of changes in reactance (DeltaXrs - cmH2O\*s/L) it will be compared to the the Mead and Whittenberger technique (via esophageal balloon measuring transpulmonary pressures). Two measurements will be obtained, DeltaXrs and Transpulmonary pressure. Comparisons of these measurements will be made to determine if the participant exhibits EFL.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

within 2 hours

Results posted on

2019-03-18

Participant Flow

Participants were recruited and screened with spirometry and determination of expiratory flow limitation prior to being enrolled into the study.

22 patient were recruited in June of 2010. * 13 patients studied * (7 didn't tolerate balloon; 2 had an exacerbation )

Participant milestones

Participant milestones
Measure	Therapy Arm Non Invasive Ventilation using forced oscillation technique (FOT)
Overall Study STARTED	22
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Therapy Arm Non Invasive Ventilation using forced oscillation technique (FOT)
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	7

Baseline Characteristics

Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Therapy Arm n=22 Participants Non Invasive Ventilation using forced oscillation technique (FOT)
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants
Age, Categorical >=65 years	12 Participants n=99 Participants
Age, Continuous	67 years STANDARD_DEVIATION 7.0 • n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=99 Participants
Region of Enrollment United Kingdom	22 participants n=99 Participants

PRIMARY outcome

Timeframe: within 2 hours

Population: All participants that completed the protocol were analyzed.

Expiratory flow limitation (EFL) is an increase in transpulmonary pressure (cmH2O) with no change expiratory flow (lpm). Expiratory Flow Limitation or absence thereof will be detected by using a measurement of changes in reactance (DeltaXrs - cmH2O\*s/L) it will be compared to the the Mead and Whittenberger technique (via esophageal balloon measuring transpulmonary pressures). Two measurements will be obtained, DeltaXrs and Transpulmonary pressure. Comparisons of these measurements will be made to determine if the participant exhibits EFL.

Outcome measures

Outcome measures
Measure	Therapy Arm n=13 Participants Non Invasive Ventilation using forced oscillation technique (FOT)
Detection of Expiratory Flow Limitation	2.6 cmH2O*s/L Interval 2.0 to 3.0

PRIMARY outcome

Timeframe: 2 hours

Population: All participants that completed the protocol were analyzed.

Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator.

Outcome measures

Outcome measures
Measure	Therapy Arm n=13 Participants Non Invasive Ventilation using forced oscillation technique (FOT)
Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator Flow limited	8 Participants
Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator Not Flow Limited	5 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: All participants that completed the protocol were analyzed.

Number of breaths are cumulative across all participants were found to be flow limited, not-flow limited or indeterminate as determined by the Mead and Wittenberger (M-W) technique of esophageal pressure. Each participant's individual breaths was imported into Matlab software program that displayed the flow vs transpleural pressure and breaths were individually analyzed according to the Mead Wittenberger technique.

Outcome measures

Outcome measures
Measure	Therapy Arm n=13 Participants Non Invasive Ventilation using forced oscillation technique (FOT)
Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique Flow limited	534 breaths
Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique Not Flow Limited	567 breaths
Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique Indeterminate	1396 breaths

Adverse Events

Therapy Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Therapy Arm n=22 participants at risk Non Invasive Ventilation using forced oscillation technique (FOT)
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease Exacerbation	9.1% 2/22 • Number of events 2 • Over course of the study which was 3 months in duration.

Additional Information

Bob Romano, Biomedical Engineer

Philips Respironics

Phone: 724-387-7781

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60