Non-invasive VentilationNCT04884828
Asynchronies in NIV With External Gas
An observational study of Non-invasive Ventilation, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
NIV can be combined with other treatments that require to introduce gas into the circuit during the treatment. This external gas produces trigger asynchronies that worse depending on the model ventilator, trigger design and gas source. It is advisable to monitor NIV when these treatments are requiring in chronic NIV. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-invasive Ventilation
- What is being tested?
- external gas during NIV
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2018to 30 Mar 2021
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients from the Pulmonology Service of the Corporació Sanitària Parc Taulí (Sabadell, Barcelona) who met the following criteria: over 18 years of age, hospital admission for acute chronic respiratory failure, home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night). Patients with underlying psychiatric disease were excluded. The study was conducted during the patient's predischarge phase (the same day or the day before)
Who may be able to join
- over 18 years of age,
- hospital admission for acute chronic respiratory failure,
- home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night).
Who cannot join
- Patients with underlying psychiatric disease were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trigger Asynchronies Induced by the Introduction of External Gas Into the Non-invasive Mechanical Ventilation Circuit: a Bench-to-bedside Study
NIV can be combined with other treatments that require to introduce gas into the circuit during the treatment. This external gas produces trigger asynchronies that worse depending on the model ventilator, trigger design and gas source. It is advisable to monitor NIV when these treatments are requiring in chronic NIV.
- Conditions
- Non-invasive Ventilation
- Being tested
- external gas during NIV
- Keywords
- Non-invasive Ventilation, trigger asynchronies, autotriggering, bench study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external gas during NIVDevice
The procedure was performed in the patient's room during his or her hospital stay to avoid additional visits for study participation. The patient was placed in the supine position, and the usual ventilator interface was placed in a single-limb system, along with the commercial ventilator to be studied. The ventilator model were evaluated at bedside in random order. The parameters of the ventilator were the same as those that the patients used at home (that is, unlike the bench study, the sensitivity of the trigger was not modified). A external polygraph was used to moritor the study, with the incorporation of thoracic and abdominal bands and parasternal electromyography, to better evaluate asynchronies, in addition to pulse oximetry control. The ventilation periods were 1 minute (without gas, gas, without gas). This sequence was performed twice in each group of established conditions.
| Study group | Role | What they receive |
|---|---|---|
| one group | patients from the Pulmonology Service of the Corporació Sanitària Parc Taulí (Sabadell, Barcelona) who met the following criteria: over 18 years of age, hospital admission for acute chronic respiratory failure, home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night). Patients with underlying psychiatric disease were excluded. The study was conducted during the patient's predischarge phase (the same day or the day before) Receives: Device: external gas during NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchronies ( yes or no)
Presence of asynchronies identify by SOMNONIV´s algorithm during the gas treatment with NIV
Measured: 1 day
Type of asynchronies
autotrigger or innefective effort identify by SOMNONIV´s group algorithm, during the gas treatment with NIV
Measured: 1 day
Secondary outcomes (4)
Type of asynchronies pre
autotrigger or innefectuve effort identify by SOMNONIV´s group pre gas during NIV treatment
Measured: 1 day
Type of asynchronies post
autotrigger or innefective effort identify by SOMNONIV´s group algorithm, , post gas during NIV
Measured: 1 day
Asynchronies ( yes or no) pre
Presence of asynchronies identify by SOMNONIV´s algorithm during pre-gas treatment with NIV
Measured: 1 day
Asynchronies ( yes or no) post
Presence of asynchronies identify by SOMNONIV´s algorithm during the post gas treatment with NIV
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Apr 2018
- Primary completion1 Mar 2021
- Study completion30 Mar 2021
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Lalmolda-Puyol, Corporacion Parc Tauli
- Investigators
- Cristina Lalmolda, RT PhD, Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884828
- Sponsor's protocol ID
- gasNIV
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigger Asynchronies Induced by the Introduction of External Gas Into the Non-invasive Mechanical Ventilation Circuit: a Bench-to-bedside Study
- ClinicalTrials.gov ID
- NCT04884828
- Acronym / sponsor ID
- gasNIV
- Conditions
- Non-invasive Ventilation
- Keywords
- Non-invasive Ventilation, trigger asynchronies, autotriggering, bench study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 13 May 2021 (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.
NIV can be combined with other treatments that require to introduce gas into the circuit during the treatment. This external gas produces trigger asynchronies that worse depending on the model ventilator, trigger design and gas source. It is advisable to monitor NIV when these treatments are requiring in chronic NIV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | – | Device: external gas during NIVpatients from the Pulmonology Service of the Corporació Sanitària Parc Taulí (Sabadell, Barcelona) who met the following criteria: over 18 years of age, hospital admission for acute chronic respiratory failure, home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night). Patients with underlying psychiatric disease were excluded. The study was conducted during the patient's predischarge phase (the same day or the day before) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from the Pulmonology Service of the Corporació Sanitària Parc Taulí (Sabadell, Barcelona) who met the following criteria: over 18 years of age, hospital admission for acute chronic respiratory failure, home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night). Patients with underlying psychiatric disease were excluded. The study was conducted during the patient's predischarge phase (the same day or the day before)
Key inclusion criteria (3 listed)
- over 18 years of age,
- hospital admission for acute chronic respiratory failure,
- home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night).
Key exclusion criteria (1 listed)
- Patients with underlying psychiatric disease were excluded
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 |
|---|---|---|
| external gas during NIVThe procedure was performed in the patient's room during his or her hospital stay to avoid additional visits for study participation. The patient was placed in the supine position, and the usual ventilator interface was placed in a single-limb system, along with the commercial ventilator to be studied. The ventilator model were evaluated at bedside in random order. The parameters of the ventilator were the same as those that the patients used at home (that is, unlike the bench study, the sensitivity of the trigger was not modified). A external polygraph was used to moritor the study, with the incorporation of thoracic and abdominal bands and parasternal electromyography, to better evaluate asynchronies, in addition to pulse oximetry control. The ventilation periods were 1 minute (without gas, gas, without gas). This sequence was performed twice in each group of established conditions. | Device | one group |
Primary outcome
Asynchronies ( yes or no)
Time frame: 1 day
Presence of asynchronies identify by SOMNONIV´s algorithm during the gas treatment with NIV
Type of asynchronies
Time frame: 1 day
autotrigger or innefective effort identify by SOMNONIV´s group algorithm, during the gas treatment with NIV
4 secondary outcomes
Type of asynchronies pre
Time frame: 1 day
Type of asynchronies post
Time frame: 1 day
Asynchronies ( yes or no) pre
Time frame: 1 day
Asynchronies ( yes or no) post
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
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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.
Cristina Lalmolda, RT PhD principal investigator
Corporacion Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-invasive Ventilation, run by Corporacion Parc Tauli 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 1 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: finished, as of the sponsor's last update on 13 May 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Asynchronies ( yes or no) (time frame: 1 day). The study lists 2 primary outcomes in all. 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 13 May 2021.