Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation (HMV)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Chronic hypercapnic respiratory failure with indication for home mechanical ventilation.

Patients who require ventilation with spontaneous-timed mode.

Signing of informed consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telemonitoring

    Other intervention

    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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Telemonitoring groupActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Measurement of pCO2 by arterial blood gas

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.

Time frame
6 months

Secondary outcomes

1

Adherence

Compare treatment adherence with Home Mechanical Ventilation (HMV) between monitoring with and without telemonitoring.

Time frame
6 months
2

Unforeseen visits

Compare the number of unforeseen visits generated with both systems.

Time frame
6 months
3

Hospital admissions

Compare the number of hospital admissions due to acute exacerbation of chronic respiratory failure with both adaptation systems.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Societat Catalana de Pneumologia (SOCAP)

Collaborator

Sociedad Española de Neumología y Cirugía Torácica

Collaborator