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
NCT Number: NCT06240637
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08025, Spain
Location status: Recruiting
Antonio Antón
SUB_INVESTIGATOR
Carolina Panadero
SUB_INVESTIGATOR
Patricia Peñacoba
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 months
Compare treatment adherence with Home Mechanical Ventilation (HMV) between monitoring with and without telemonitoring.
Time frame: 6 months
Compare the number of unforeseen visits generated with both systems.
Time frame: 6 months
Compare the number of hospital admissions due to acute exacerbation of chronic respiratory failure with both adaptation systems.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Other
Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation
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.
Published trials that share one or more normalized conditions with this study.
NCT07423338
Acute Respiratory Failure (ARF), Non Invasive Ventilation
London, United Kingdom
View Trial DetailsNCT06622902
Female Urogenital Diseases and Pregnancy Complications, Lung Diseases
Haifa, Israel
View Trial DetailsNCT05368662
Non Invasive Ventilation, Quality of Life
Angers, Maine et Loire, France
View Trial DetailsNCT05712330
Central Nervous System Diseases, Motor Neuron Disease
Amiens, Picardie, France
View Trial Details