NCT06240637

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

Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Invasive Ventilation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-17
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-02-05
• Last updated: 2024-03-22

Locations

1 site across 1 country: Spain