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

NCT ID: NCT06240637

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-17
• Study Completion Date: 2026-12-01

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.

Conditions

Non Invasive Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telemonitoring group

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.

Group Type: ACTIVE_COMPARATOR

Telemonitoring

Intervention Type: OTHER

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.

Control group

Exclusive in-person follow-up model with control visits at 2 weeks, 1, 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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Societat Catalana de Pneumologia (SOCAP)

UNKNOWN

Sponsor Role: collaborator

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Patricia Peñacoba

Role: primary

ppenacoba@santpau.cat

935537324

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IIBSP-TEL-2022-132

Identifier Type: -

Identifier Source: org_study_id