Patient-ventilator Interactions in Long Term Non-invasive Ventilation: Influence of Back-up Frequency

NCT01130090 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2011-02-24

No results posted yet for this study

Summary

In patients under bi-level pressure support ventilation for obesity hypoventilation syndrome, this study aims to determine if it is better, in terms of efficacy and patient-ventilator synchronisation to use

* Spontaneous mode (S)
* Spontaneous/Timed mode (ST) with an intermediate back-up rate, slightly below the respiratory rate of the patient
* Timed mode (T), with a ventilator respiratory rate above that of the patient. This issue has to our knowledge only been marginally studied without any consensus.

Conditions

Interventions

DEVICE

Adjustment of back-up respiratory rate on bi-level ventilator

3 consecutive nights in randomized order, in either "S" (Spontaneous) mode, "ST" (Spontaneous/Timed) mode with a back-up rate under spontaneous respiratory rate of the patient, or in "ST" (Spontaneous/Timed) mode with a back-up rate at least 2 cycles/minute above spontaneous nocturnal respiratory rate. Each assessment will include complete polysomnographic recording (sleep study) as well as SpO2, PtcCO2, pneumotachograph (flow), mask pressure, quantitative assessment of patient-ventilator synchronisation, central or obstructive apnea and hypopnea, data of built-in software, and rating of patient comfort

Sponsors & Collaborators

  • Ligue Pulmonaire Genevoise

    lead OTHER

Principal Investigators

  • Jean-Paul Janssens, MD · University Hospital, Geneva

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT01130090 on ClinicalTrials.gov