Home Mechanical Ventilation Effectiveness and Air Leaks

Prediction of Home Mechanical Ventilation Effectiveness by Means of Non-controlled Air Leaks Estimation.

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease; COPD; Chronic Respiratory Failure

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
- 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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: March 19, 2010
• First Submitted That Met QC Criteria: March 22, 2010
• First Posted (Estimate): March 23, 2010

Study Record Updates

• Last Update Posted (Estimate): February 24, 2014
• Last Update Submitted That Met QC Criteria: February 21, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Restrictive pulmonary disease with hypercapnic chronic respiratory failure.; COPD patients who need NIV hypercapnic chronic respiratory failure.
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency
• Other Study ID Numbers: PR02/02/2007