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
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