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

Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation

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).

Study Overview

• Status: Recruiting
• Conditions: Non Invasive Ventilation
• Intervention / Treatment: Other: Telemonitoring

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    • Contact: Patricia Peñacoba; Phone Number: 935537324; Email: ppenacoba@santpau.cat
    • Sub-Investigator: Carolina Panadero
    • Sub-Investigator: Antonio Antón

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Sociedad Española de Neumología y Cirugía Torácica; Societat Catalana de Pneumologia (SOCAP)

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Telemonitoring; NIV
• Other Study ID Numbers: IIBSP-TEL-2022-132

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No