Auto-trilevel Ventilator for Patients With Overlap Syndrome

NCT01523197 | Completed

• 1 other identifier: CXZZ11-0711
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Overlap Syndrome

Keywords

Obstructive Sleep Apnea hypopnea Syndrome; COPD; overlap syndrome; Auto-trilevel ventilation; BiPAP ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants will be observed for the duration of hospital stay, an expected average of 1 weeks

Study Arms (1)

ventilator

OTHER

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

Device: BiPAP ventilation, auto-trilevel ventilation

Interventions

BiPAP ventilation, auto-trilevel ventilation DEVICE

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.

Also known as: bi-level postive airway preesure ventilation;, auto-trilevel ventilation

ventilator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• xilong zhang, MD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Respirology, The First Affiliated Hospital of Nanjing Medical University

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: February 1, 2012
• Study Start: August 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

CN (1)