Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation (HMV)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telemonitoring.
- Who it may be relevant to
- Registry conditions: Non Invasive Ventilation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation
Overview
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
- Other Telemonitoring
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.
Primary outcome measures
- Measurement of pCO2 by arterial blood gas [Time frame: 6 months]
Secondary outcome measures (3)
- Adherence [Time frame: 6 months]
- Unforeseen visits [Time frame: 6 months]
- Hospital admissions [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau — Barcelona
Identifiers
NCT: NCT06240637 · IIBSP-TEL-2022-132