Non Invasive Ventilation
Conditions
Keywords
Telemonitoring, NIV
Brief summary
The goal of this clinical trial is to evaluate whether telemonitoring, added to the usual process of adaptation to home mechanical ventilation (HMV), achieves a more efficient correction of hypoventilation (reduction of hypercapnia).
Detailed description
The study population consist of patients with hypercapnic respiratory failure eligible for Home Mechanical Ventilation (HMV) with a total of 48 subjects (24 per group). In those patients with hypercapnic respiratory failure who have an indication for home mechanical ventilation (HMV), without criteria for life support, the initial titration will be performed following the protocol of the Pulmonology Service. After their education, patients will be randomized into one of the following groups: the control group and the telemonitoring group with daily review of Home Mechanical Ventilation (HMV) data. The objectives are to evaluate whether hypoventilation is corrected more efficiently, compare treatment adherence between both groups, analyze unforeseen visits, and assess the number of hospital admissions.
Interventions
OTHERTelemonitoring
A networked platform that enables the telemonitoring of both compliance data and the patient's ventilatory pattern, allowing the assessment of flow/pressure curves as well as leaks or events related to the upper airway.
Sponsors
Societat Catalana de Pneumologia (SOCAP)
Sociedad Española de Neumología y Cirugía Torácica
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic hypercapnic respiratory failure with indication for home mechanical ventilation. * Patients who require ventilation with spontaneous-timed mode. * Signing of informed consent.
Exclusion criteria
* Patient already treated with mechanical ventilation or home CPAP. * Patient requiring mechanical ventilation as life support. * Pregnancy. * Cognitive impairment that makes it impossible to understand the informed consent for the study. * Psychiatric pathology that makes compliance with therapy or its follow-up difficult. * Impossibility of complying with the protocol. * Expected survival less than 12 months. * Any other condition that, in the opinion of the researcher, could interfere with the objectives of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of pCO2 by arterial blood gas | 6 months | The partial pressure of carbon dioxide (PCO2) is the measure of carbon dioxide within arterial or venous blood. The moment (day) in which normal pCO2 is detected (pCO2 \< 45 mmHg) will be determined as the success of the therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 6 months | Compare treatment adherence with Home Mechanical Ventilation (HMV) between monitoring with and without telemonitoring. |
| Unforeseen visits | 6 months | Compare the number of unforeseen visits generated with both systems. |
| Hospital admissions | 6 months | Compare the number of hospital admissions due to acute exacerbation of chronic respiratory failure with both adaptation systems. |
Countries
Spain
Outcome results
None listed