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

NCT06240637 | Recruiting

• 1 other identifier: IIBSP-TEL-2022-132
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Non Invasive Ventilation

Keywords

Telemonitoring; NIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adherence

  6 months

• Unforeseen visits

  6 months

• Hospital admissions

  6 months

Study Arms (2)

Telemonitoring group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

Telemonitoring 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.

Telemonitoring group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hypercapnic respiratory failure with indication for home mechanical ventilation.
• Patients who require ventilation with spontaneous-timed mode.
• Signing of informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Barcelona, 08025, Spain

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 5, 2024
• Study Start: February 17, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-01

Locations

ES (1)