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

Non Invasive Ventilation Clinical Trial

Official title:

Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06240637
• Other study ID #: IIBSP-TEL-2022-132
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2024
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non Invasive Ventilation

Intervention

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.

Locations

Country	Name	City	State
Spain	Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Sociedad Española de Neumología y Cirugía Torácica, Societat Catalana de Pneumologia (SOCAP)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	Adherence	Compare treatment adherence with Home Mechanical Ventilation (HMV) between monitoring with and without telemonitoring.	6 months
Secondary	Unforeseen visits	Compare the number of unforeseen visits generated with both systems.	6 months
Secondary	Hospital admissions	Compare the number of hospital admissions due to acute exacerbation of chronic respiratory failure with both adaptation systems.	6 months