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Auto-trilevel Ventilator for Patients With Overlap Syndrome

Primary Purpose

Overlap Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
BiPAP ventilation, auto-trilevel ventilation
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overlap Syndrome focused on measuring Obstructive Sleep Apnea hypopnea Syndrome, COPD, overlap syndrome, Auto-trilevel ventilation, BiPAP ventilation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient or legal representative of the patient is willing and able to sign an approved informed consent and privacy protection authorization in the United States.
  2. Subject is >18 years old.
  3. Diagnosed overlap syndrome(OSAS and COPD). 4. Expected to tolerate the ventilator therapy .

Exclusion Criteria:

  1. Patient is currently enrolled in another clinical study which may confound the result of this study.
  2. Patient for who inform consent cannot be obtained.
  3. Patients with a history of cerebrovascular accident within the 6 months prior to this study.
  4. Patients with acute or chronic renal failure, diabetes and severe lung diseases.
  5. Patients with unstable angina.
  6. Patient who is of pregnant or during lactation period.
  7. Patients with a history of injury or surgery within 6 months prior to the study.

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ventilator

Arm Description

The comparison of the curative effect on OS between BiPAP and auto-trilevel ventilations

Outcomes

Primary Outcome Measures

different effects between BiPAP and auto-Trilevel ventilators on OS
The overall purpose of this study is to determine the effects of auto-Trilevel ventilation on patients with overlap syndrome by comparison with BiPAP ventilation. The following parameters are compared such as apnea hypopnea index, lowest SPO2, arousal index, sleep efficiency, PaCO2, daytime sleepiness and so on.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2012
Last Updated
November 26, 2012
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01523197
Brief Title
Auto-trilevel Ventilator for Patients With Overlap Syndrome
Official Title
Effect of Auto-Trilevel Ventilation on Patients With Overlap Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Obstructive Sleep Apnea Syndrome (OSAS) and chronic obstructive pulmonary disease (COPD) are two diseases that often coexist and are called overlap syndrome(OS). Compared to single OSAS, OS patients are more susceptible to serious hypoxia and hypercapnia especially during sleep, and are much more likely to result in pulmonary hypertension and cor-pulmonal. With a more flexible expiratory positive airway pressure (EPAP), auto-trilevel ventilation may be superior to fixed bilevel positive airway pressure (BiPAP) ventilation in both removing residual obstructive sleep apnea hypopnea events and correcting hypercapnia simultaneously. The overall purpose of this study is to compare the curative effects between fixed BiPAP and auto-trilevel ventilations on OS patients.
Detailed Description
The contradiction in treatment for overlap syndrome is how to improve hypercapnia because of narrower difference between inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP), and meanwhile to eliminate apnea and popnea events which may easily occur at the end of expiration For ordinary Bipap ventilator. If the IPAP is set to higher, the patients may feel discomfort, if the pressure difference between IPAP and EPAP is too narrow or the expiratory positive airway pressure (EPAP) too high, hypercapnia may occur. If the EPAP is too low, redusual apnea and hypopnea event may become common. Auto-trilevel ventilation, with a lower airway pressure at the beginning of expiration to prevent hypercapnia and a higher airway pressure at the end of expiration to prevent residual apnea events, should be able to provide a novel ventilation mode with a higher efficacy and lower average airway pressure for overlap syndrome. To prove the hypothesis, comparison is made between ordinary BiPAP and auto-Trilevel ventilation modes during treatment for patients with overlap syndrome. In this study, the investigators compare the changes of related indexes including apnea hypopnea index、minimal pulse oxygen saturation、arousal index, sleep quality,PaCO2 and sleepiness scores) before and on treatment. Meanwhile, curative effects will be compared between BiPAP and auto-Trilevel ventilation modes. The investigators will analyze the changes and then confirm our hypothesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overlap Syndrome
Keywords
Obstructive Sleep Apnea hypopnea Syndrome, COPD, overlap syndrome, Auto-trilevel ventilation, BiPAP ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ventilator
Arm Type
Other
Arm Description
The comparison of the curative effect on OS between BiPAP and auto-trilevel ventilations
Intervention Type
Device
Intervention Name(s)
BiPAP ventilation, auto-trilevel ventilation
Other Intervention Name(s)
bi-level postive airway preesure ventilation;, auto-trilevel ventilation
Intervention Description
Noninvasive ventilation including fixed BiPAP ventilation and auto-trilevel ventilation. Using the same IPAP, treatment include one night with BiPAP ventilation mode 1, one night with BiPAP ventilation mode 2 and one night with auto-trilevel ventilation mode. Each treatment last 8 hours for each night.
Primary Outcome Measure Information:
Title
different effects between BiPAP and auto-Trilevel ventilators on OS
Description
The overall purpose of this study is to determine the effects of auto-Trilevel ventilation on patients with overlap syndrome by comparison with BiPAP ventilation. The following parameters are compared such as apnea hypopnea index, lowest SPO2, arousal index, sleep efficiency, PaCO2, daytime sleepiness and so on.
Time Frame
Participants will be observed for the duration of hospital stay, an expected average of 1 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient or legal representative of the patient is willing and able to sign an approved informed consent and privacy protection authorization in the United States. Subject is >18 years old. Diagnosed overlap syndrome(OSAS and COPD). 4. Expected to tolerate the ventilator therapy . Exclusion Criteria: Patient is currently enrolled in another clinical study which may confound the result of this study. Patient for who inform consent cannot be obtained. Patients with a history of cerebrovascular accident within the 6 months prior to this study. Patients with acute or chronic renal failure, diabetes and severe lung diseases. Patients with unstable angina. Patient who is of pregnant or during lactation period. Patients with a history of injury or surgery within 6 months prior to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xilong zhang, MD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China

12. IPD Sharing Statement

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Auto-trilevel Ventilator for Patients With Overlap Syndrome

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