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NCT Number: NCT06240637

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Barcelona, 08025, Spain

Location status: Recruiting

Location contact

Antonio Antón

SUB_INVESTIGATOR

Carolina Panadero

SUB_INVESTIGATOR

Patricia Peñacoba

CONTACT

[email protected]

935537324

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Measurement of pCO2 by arterial blood gas

    Time frame: 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 outcomes

  1. Adherence

    Time frame: 6 months

    Compare treatment adherence with Home Mechanical Ventilation (HMV) between monitoring with and without telemonitoring.

  2. Unforeseen visits

    Time frame: 6 months

    Compare the number of unforeseen visits generated with both systems.

  3. Hospital admissions

    Time frame: 6 months

    Compare the number of hospital admissions due to acute exacerbation of chronic respiratory failure with both adaptation systems.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Sociedad Española de Neumología y Cirugía Torácica
  • Societat Catalana de Pneumologia (SOCAP)

Registry information

Official study title

Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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