Neuromuscular DisordersNCT01991535
Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern
A study testing Spontaneous Ventilation Mode and Simulator Ventilation Mode in people with Neuromuscular Disorders and Chest Wall Disorders, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether breathing pattern (specifically the inspiratory time/total respiratory cycle value) has an influence over the response to the noninvasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neuromuscular Disorders, Chest Wall Disorders, Obesity Hypoventilation Syndrome (OHS)
- What is being tested?
- Spontaneous Ventilation Mode and Simulator Ventilation Mode
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Start not givento Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypercapnic chronic respiratory failure due to restrictive pulmonary disease (with usual criteria for home NonInvasive Mechanical Ventilation).
- Transcutaneous carbon dioxide (CO2) basal pressure ≥ 50 mmHg when conscious.
- Clinically stable (within the previous month).
- Patients without previous NonInvasive Mechanical Ventilation treatment.
Who cannot join
- Clinical exacerbation.
- Chronic airflow limitation Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio < 70% or Sleep Apnea-Hypopnea Syndrome
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
About this study
The purpose of this study is to determine whether breathing pattern (specifically the inspiratory time/total respiratory cycle value) has an influence over the response to the noninvasive mechanical ventilation.
Read the detailed description
Breathing pattern will be analyzed along the adaptation to 3 different NonInvasive-Mechanical-Ventilation modes (controlled mode, spontaneous mode and placebo mode or simulator).
- Being tested
- Spontaneous Ventilation Mode, Controlled Ventilation Mode, Simulator Ventilation Mode
- Medical subject headings
- Neuromuscular Diseases, Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous Ventilation ModeDevice
Respiratory rate and duration of inspiration are controlled by the patient.
Device model: Stellar 150® (ResMed, Australia).
Controlled Ventilation ModeDevice
Ventilator maintains the positive end-expiratory pressure until the patient inspires. At that point, the ventilator reaches the support pressure in a predetermined time. The patient fixes the respiratory rate and the duration of inspiration, triggering all the cycles.
Device model: Stellar 150® (ResMed, Australia).
Simulator Ventilation ModeDevice
Ventilator maintains a continuous positive airway pressure during the entire cycle.
Device model: Stellar 150® (ResMed, Australia).
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcutaneous carbon dioxide measurement
Measured: One hour
Secondary outcomes (1)
Inspiratory-time/total-respiratory-cycle value
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DisordersStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro A Anton Albisu, Medical Dr, Principal investigator, Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant PauPatricia Peñacoba Toribio, Physician, Study chair, Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant PauMacarena Segura, Physiotherapist, Study chair, Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991535
- Sponsor's protocol ID
- IIBSP-VEN-2013-23
- Status last verified
- Oct 2015
- First submitted
- 18 Nov 2013
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern
- ClinicalTrials.gov ID
- NCT01991535
- Acronym / sponsor ID
- IIBSP-VEN-2013-23
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Primary completion
- Dec 2016 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- 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 purpose of this study is to determine whether breathing pattern (specifically the inspiratory time/total respiratory cycle value) has an influence over the response to the noninvasive mechanical ventilation.
Detailed description
Breathing pattern will be analyzed along the adaptation to 3 different NonInvasive-Mechanical-Ventilation modes (controlled mode, spontaneous mode and placebo mode or simulator).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypercapnic chronic respiratory failure due to restrictive pulmonary disease (with usual criteria for home NonInvasive Mechanical Ventilation).
- Transcutaneous carbon dioxide (CO2) basal pressure ≥ 50 mmHg when conscious.
- Clinically stable (within the previous month).
- Patients without previous NonInvasive Mechanical Ventilation treatment.
Key exclusion criteria (2 listed)
- Clinical exacerbation.
- Chronic airflow limitation Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio < 70% or Sleep Apnea-Hypopnea Syndrome
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 |
|---|---|---|
| Spontaneous Ventilation ModeRespiratory rate and duration of inspiration are controlled by the patient. Device model: Stellar 150® (ResMed, Australia). | Device | – |
| Controlled Ventilation ModeVentilator maintains the positive end-expiratory pressure until the patient inspires. At that point, the ventilator reaches the support pressure in a predetermined time. The patient fixes the respiratory rate and the duration of inspiration, triggering all the cycles. Device model: Stellar 150® (ResMed, Australia). | Device | – |
| Simulator Ventilation ModeVentilator maintains a continuous positive airway pressure during the entire cycle. Device model: Stellar 150® (ResMed, Australia). | Device | – |
Primary outcome
Transcutaneous carbon dioxide measurement
Time frame: One hour
1 secondary outcome
Inspiratory-time/total-respiratory-cycle value
Time frame: One hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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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. This study is not recruiting at the moment.
Pedro A Anton Albisu, Medical Dr principal investigator
Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
Patricia Peñacoba Toribio, Physician study chair
Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
Macarena Segura, Physiotherapist study chair
Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spontaneous Ventilation Mode and Simulator Ventilation Mode in people with Neuromuscular Disorders and Chest Wall Disorders, 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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 21 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcutaneous carbon dioxide measurement (time frame: One hour). 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 21 Mar 2024.