Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06240637

Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation

Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2024-03-22

48

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

F

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

Lead Sponsor

S

Societat Catalana de Pneumologia (SOCAP)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding telemonitoring to the usual adaptation process for home mechanical ventilation (HMV) helps correct hypoventilation more efficiently in patients with chronic hypercapnic respiratory failure. The study includes 48 patients eligible for HMV who do not require life support. The goal is to compare the effectiveness of telemonitoring versus standard care in reducing high carbon dioxide levels in the blood, as well as treatment adherence, unplanned visits, and hospital admissions. Participants will be randomly assigned to one of two groups: a telemonitoring group or a control group. The telemonitoring group will have their HMV data reviewed daily for the first two weeks, then weekly up to six months, with phone contact and timely therapy adjustments. The control group will receive standard in-person follow-up visits at 2 weeks, 1, 2, 4, and 6 months after starting HMV, with clinical assessments and therapy adjustments. Both groups undergo similar clinical and gasometric controls, nocturnal pulse oximetry, questionnaires, and ventilator data downloads. During the study, participants will attend scheduled follow-up visits to monitor their respiratory status and ventilator use. Researchers will measure arterial blood carbon dioxide (pCO2) levels at six months as the primary outcome. Secondary outcomes include treatment adherence, unforeseen visits, and hospital admissions over six months. The study aims to provide insight into the benefits of telemonitoring for patients adjusting to home mechanical ventilation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic hypercapnic respiratory failure with indication for home mechanical ventilation.
  • Patients who require ventilation with spontaneous-timed mode.
  • Signing of informed consent.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants begin home mechanical ventilation (HMV) with education and titration. Those randomized to the telemonitoring group will have daily remote review of HMV data for the first 2 weeks, then weekly telemonitoring up to 6 months. The control group will have in-person follow-up visits. Both groups may have therapy adjustments as needed.

Telemonitoring group: daily remote monitoring for 2 weeks, then weekly; in-person visits at 2, 4, and 6 months. Control group: in-person visits at 2 weeks, 1, 2, 4, and 6 months.

Trial Site Locations

Total: 1 location

1

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

Barcelona, Spain, 08025

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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