Non Invasive VentilationNCT06240637
Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation (HMV)
A study testing Telemonitoring in people with Non Invasive Ventilation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Invasive Ventilation
- What is being tested?
- Telemonitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hypercapnic respiratory failure with indication for home mechanical ventilation.
- Patients who require ventilation with spontaneous-timed mode.
- Signing of informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Patricia Peñacoba, 935537324, ppenacoba@santpau.cat
Carolina Panadero
About this study
Official title: 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).
Read the 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.
- Conditions
- Non Invasive Ventilation
- Being tested
- Telemonitoring
- Keywords
- Telemonitoring, NIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Adherence
Compare treatment adherence with Home Mechanical Ventilation (HMV) between monitoring with and without telemonitoring.
Measured: 6 months
Unforeseen visits
Compare the number of unforeseen visits generated with both systems.
Measured: 6 months
Hospital admissions
Compare the number of hospital admissions due to acute exacerbation of chronic respiratory failure with both adaptation systems.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start17 Feb 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Invasive VentilationStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Societat Catalana de Pneumologia (SOCAP), Sociedad Española de Neumología y Cirugía Torácica
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240637
- Sponsor's protocol ID
- IIBSP-TEL-2022-132
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring Utility in the Process of Adaptation to Home Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06240637
- Acronym / sponsor ID
- IIBSP-TEL-2022-132
- Conditions
- Non Invasive Ventilation
- Keywords
- Telemonitoring, NIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Societat Catalana de Pneumologia (SOCAP), Sociedad Española de Neumología y Cirugía Torácica
- Study start
- 17 Feb 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring group | Active comparator | Other: TelemonitoringFollow-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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic hypercapnic respiratory failure with indication for home mechanical ventilation.
- Patients who require ventilation with spontaneous-timed mode.
- Signing of informed consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemonitoringA 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. | Other | Telemonitoring group |
Primary outcome
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.
3 secondary outcomes
Adherence
Time frame: 6 months
Unforeseen visits
Time frame: 6 months
Hospital admissions
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
Related trials for Non Invasive Ventilation
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Validation of the Turkish Version of the S3-NIV Questionnaire
Respiratory Insufficiency, Chronic Respiratory Failure
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with Non Invasive Ventilation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pCO2 by arterial blood gas (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.