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Adaptive Non-invasive Ventilation to Abolish Tidal Flow Limitation

NCT04497090 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-08-04

No results posted yet for this study

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.

Conditions

  • Pulmonary Disease, Chronic Obstructive
  • Hypercapnia
  • Ventilator Lung

Interventions

DEVICE

fixed-EPAP

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

DEVICE

auto-EPAP

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

Sponsors & Collaborators

  • Istituti Clinici Scientifici Maugeri SpA

    collaborator OTHER

  • Philips Healthcare

    collaborator INDUSTRY

  • Politecnico di Milano

    lead OTHER

Principal Investigators

  • Raffaele L Dellacà, Prof. · Politecnico di Milano

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-23
Primary Completion
2018-05-15
Completion
2018-05-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04497090 on ClinicalTrials.gov