Clincosm LogoSign in Get a demo

Home Mechanical Ventilation Effectiveness and Air Leaks

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Completed
CT.gov ID
NCT01090986
Collaborator
(none)
20
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Non invasive ventilation (NIV) usually presents air leaks that may determine the result of this treatment. The clinical usefulness of analyzing (and quantifying) these leaks during the adaptation period to NIV has not been evaluated in prospective clinical studies as a predictive data of treatment effectiveness. Our hypothesis is that air leaks are correlated to a successful adaptation to NIV. And air leak magnitude may predict early failures of this treatment. And also, as we do not know if air leaks change during the adaptation period to NIV, we do not know whether early detection of air leaks plays a role in the therapeutic outcome. Our objective is to evaluate the clinical usefulness of quantifying air leaks during the adaptation period to NIV as a predictor of effectiveness of this treatment. We also want to evaluate the correlation between air leaks and clinical-functional patients' profile, and the ventilatory parameters selected and to evaluate air leaks variability during the adaptation period to NIV. Method: We will determine the air leak magnitude in twenty patients during adaptation to NIV. We will use VPAP III ventilators (ResMed, Australia), commercial nasal masks (Mirage o Ultra Mirage) and VPAP III/ResLinkTM (ResMed, North Ryde, Australia), a device that includes a monitoring system coupled with the VPAP III ventilator. This device allows to record air leaks and other ventilation parameters. We will perform four VPAP III/ResLinkTM recordings in each patient (the last night in hospital during the adaptation period, the first night at home, and one and two months later, after the initiation of NIV treatment). We will also perform a complete pulmonary function test, quality-of-life questionnaire (SF36), and a tolerance to NIV questionnaire in all patients at the onset of NIV treatment and two months later. We will evaluate which patients will need to change treatment at the end of the adaptation period to NIV. We also will analyze and compare air leaks magnitude in each of the four recordings stated above.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prediction of Home Mechanical Ventilation Effectiveness by Means of Non-controlled Air Leaks Estimation.
    Study Start Date :
    Jun 1, 2006
    Actual Primary Completion Date :
    Jul 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Patients with a restrictive pulmonary disease and hypercapnic chronic respiratory failure with standard criteria for NIV. Also COPD patients who need NIV because of another reason (obesity, nocturnal hyperventilation or nocturnal hypercapnic response to oxygen).

    Outcome Measures

    Primary Outcome Measures

    1. Clinical usefulness of quantifying AIR LEAKS during the adaptation period to NIV as a predictor of effectiveness (pCO2 EVOLUTION) of this treatment. [One year]

    Secondary Outcome Measures

    1. - Air leaks AND patients' characteristics.- Some indices (air leaks/inspiratory pressure...)and NIV effectiveness. - Air leak evolution.- Air leaks and patients' tolerance to NIV. [One year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with a restrictive pulmonary disease (slow evolution neuromuscular or thorax cage diseases, obesity or nocturnal hypoventilation) and hypercapnic chronic respiratory failure with standard criteria for NIV.

    • COPD patients who need NIV because of another reason (obesity, nocturnal hyperventilation or nocturnal hypercapnic response to oxygen).

    • PaCO2 ≥ de 50 mmHg.

    • Clinically stable (at least for one month).

    • Possibility to fit a nasal mask for NIV treatment (ultra mirage, mirage).

    Exclusion Criteria:

    • Rapid evolution neuromuscular disease (Amyotrophic Lateral Sclerosis).

    • Serious comorbidity.

    • Lack of patients comprehension or collaboration.

    • Inability to fit a nasal mask for NIV treatment (ultra mirage, mirage).

    • Treatment compliance < 4h/d.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025

    Sponsors and Collaborators

    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Investigators

    • Principal Investigator: Carme Puy, MD, Hospital Santa Creu i Sant Pau

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    ClinicalTrials.gov Identifier:
    NCT01090986
    Other Study ID Numbers:
    • PR02/02/2007
    First Posted:
    Mar 23, 2010
    Last Update Posted:
    Feb 24, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    Restrictive pulmonary disease with hypercapnic chronic respiratory failure.
    COPD patients who need NIV hypercapnic chronic respiratory failure.
    Additional relevant MeSH terms:
    Lung Diseases
    Respiratory Insufficiency

    Study Results

    No Results Posted as of Feb 24, 2014