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Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm

NCT01403584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-03-26

Study results available
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Summary

The aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure. For this purpose, The investigators will study different groups of patients, including those with obstructive and restrictive ventilatory defect, and obstructive sleep apnoea, non-naive to conventional bi-level positive airways pressure therapy.

Conditions

  • Respiratory Insufficiency
  • Sleep Disordered Breathing

Interventions

DEVICE

AutoVPAP with addition of AutoEPAP

Implementation of automated algorithm for adjustment of conventional device parameter (EPAP0.

DEVICE

AutoVPAP with EPAP manually selected

Conventionally applied Expiratory Positive Airway Pressure (EPAP)

Sponsors & Collaborators

  • University Hospital, Essen

    collaborator OTHER

  • ResMed

    lead INDUSTRY

Principal Investigators

  • Helmut Teschler, Dr. med. · Abteilung Pneumologie - Universitätsklinik, Essen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Germany

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 NCT01403584 on ClinicalTrials.gov