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

Not Applicable

Recruiting

• Conditions: Non Invasive Ventilation
• Interventions: Other: Telemonitoring

• Registration Number: NCT06240637
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-02-05
• Study Start: 2024-02-17
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring group	Telemonitoring	Follow-up model adding telemonitoring with remote review of HMV data on a daily basis during the first 2 weeks and subsequently weekly up to 6 months. Telephone contact with the patient in case of any eventuality and timely adjustments to therapy. Patients will attend in-person follow-up visits at 2, 4, and 6 months after initiating HMV. Clinical and gasometric control, nocturnal pulse oximetry, questionnaires, and download of ventilator data. Timely adjustments to therapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain