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Continuous Positive Pressure Versus Bi-level in Overlap Syndrome

NCT03766542 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-12-06

No results posted yet for this study

Summary

Continuous positive airway pressure (CPAP) became the established treatment for overlap syndrome (OS). It has been showed that the survival benefits of CPAP favored hypercapnic patients. When considering hypercapnic stable COPD patients, survival benefits occurred when the use of bi- level ventilation therapy was targeted to significantly reduce hypercapnia.

This highlights the relevance of hypercapnia and hypoventilation correction. Thus, the purpose of this study is to compare the use of CPAP to Bi-level ventilation in hypercapnic OS patients, since the later may correct not only the airway patency but also increase the magnitude of each breath.

Conditions

  • Overlap Syndrome
  • Nocturnal Hypoventilation

Interventions

DEVICE

Bi-level positive airway pressure with ventilatory support

Positive airway pressure will be applied in the experimental group through a oronasal interface, in ventilatory support mode (Bi-level) with a fixed backup rate.

DEVICE

continuous positive airway pressure without ventilatory support

Continuous positive airway pressure (CPAP) will be applied in the active comparator group through a oronasal interface.

Sponsors & Collaborators

  • Marta Drummond MD PhD

    collaborator UNKNOWN

  • Joao Carlos Winck MD PhD

    collaborator UNKNOWN

  • Mafalda van Zeller MD Phstud

    collaborator UNKNOWN

  • Hospital Sao Joao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-07-01
Completion
2020-09-01

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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 NCT03766542 on ClinicalTrials.gov