Adaptive Non-invasive Ventilation to Abolish Tidal Flow Limitation

Non-invasive Ventilation With Automatic Expiratory Positive Airway Pressure Titration to Abolish Tidal Expiratory Flow Limitation in COPD Patients With Chronic Hypercapnia

Sponsors

Lead Sponsor: Politecnico di Milano

Collaborator: Istituti Clinici Scientifici Maugeri SpA
Philips Healthcare

Source Politecnico di Milano
Brief Summary

This study aimed to evaluate the effects of a novel automatic non-invasive ventilation (NIV) mode that continuously adjusts expiratory positive airway pressure (EPAP) to the lowest value that abolishes tidal expiratory flow limitation. The investigators conducted a prospective, randomized, cross-over study on stable chronic obstructive pulmonary disease (COPD) patients. Patients were studied in the hospital during two non-consecutive nights while using either fixed or adaptive EPAP. The primary outcome was the transcutaneous partial pressure of carbon dioxide. Secondary outcomes were: oxygen saturation, breathing pattern, oscillatory mechanics, patient-ventilation asynchronies, sleep quality and sleep-related respiratory events.

Detailed Description

Study design: prospective, randomized, cross-over study. Study population: moderate to severe COPD patients, long-term users of nocturnal non-invasive ventilation for chronic hypercapnic respiratory failure. Inclusion criteria: age<85 years; presence of tidal expiratory flow limitation in the supine position at an expiratory positive airway pressure of 4 cmH2O. Exclusion criteria: COPD exacerbation within the past two months; acute illness; clinical instability. Study protocol: Patients were studied in the hospital over 2 non-consecutive nights while using either fixed or automatic EPAP. Ventilation strategy: pressure-controlled NIV was delivered using a non-commercial version of BiPAP Synchrony Ventilator (Philips-Respironics) via an unvented facial mask (AMARA, Philips-Respironics). The ventilator evaluated the presence of tidal expiratory flow limitation by the forced oscillation technique. In the automatic-EPAP mode, the ventilator continuously adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation, with a minimum EPAP of 4 cmH2O and keeping the pressure support constant. Measurements: During each study night, the investigators recorded transcutaneous partial pressure of carbon dioxide and oxygen saturation (TOSCA, Radiometer) continuously. Airway opening pressure, flow and volume tracings were exported from the ventilator. Full laboratory polysomnography (Alice5, Philips-Respironics) was performed according to the American Academy of Sleep Medicine recommendations. Data analysis: the investigators compared parameters from the two nights using Wilcoxon signed-rank test. P-values <0.05 were considered statistically significant.

Overall Status Completed
Start Date October 23, 2014
Completion Date May 15, 2018
Primary Completion Date May 15, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean transcutaneous partial pressure of carbon dioxide (PtcCO2) Overnight (about 8 hours)
Percent of night time spent in hypercapnia Overnight (about 8 hours)
Secondary Outcome
Measure Time Frame
Mean peripheral oxygen saturation (SpO2) Through study completion, an average of 8 hours
Desaturation Through study completion, an average of 8 hours
Number of ineffective efforts per hour (IE) Through study completion, an average of 8 hours
Sleep quality Through study completion, an average of 8 hours
EPAP Through study completion, an average of 8 hours
Breathing pattern Through study completion, an average of 8 hours
Difference between mean inspiratory and expiatory reactance Through study completion, an average of 8 hours
Mean inspiratory resistance Through study completion, an average of 8 hours
Mean inspiratory reactance Through study completion, an average of 8 hours
Sleep related respiratory event Through study completion, an average of 8 hours
Enrollment 12
Condition
Intervention

Intervention Type: Device

Intervention Name: fixed-EPAP

Description: In the fixed-EPAP mode, the device kept EPAP fixed at the prescribed value

Arm Group Label: Fixed-EPAP

Intervention Type: Device

Intervention Name: auto-EPAP

Description: In the Auto-EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation.

Arm Group Label: Auto-EPAP

Eligibility

Criteria:

Inclusion Criteria: - moderate to severe COPD (GOLD 2017); - long-term users of nocturnal non-invasive ventilation for chronic hypercapnic respiratory failure; - presence of tidal expiratory flow limitation in the supine position at an expiratory positive airway pressure of 4 cmH2O. Exclusion Criteria: - COPD exacerbation within the past two months; - acute illness; - clinical instability.

Gender: All

Minimum Age: 18 Years

Maximum Age: 84 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Raffaele L Dellacà, Prof. Principal Investigator Politecnico di Milano
Location
Facility: Divisione di Pneumologia, Fondazione S. Maugeri, IRCCS
Location Countries

Italy

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Politecnico di Milano

Investigator Full Name: Raffaele Dellaca

Investigator Title: Prof

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Fixed-EPAP

Type: Active Comparator

Description: EPAP was kept fixed at the prescribed level throughout the night

Label: Auto-EPAP

Type: Experimental

Description: EPAP was continuously adjusted using the experimental approach aimed at abolishing tidal expiratory flow limitation

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov