Asynchronies in NIV With External Gas

Study Overview
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Brief Summary
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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.

Official Title
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Trigger Asynchronies Induced by the Introduction of External Gas Into the Non-invasive Mechanical Ventilation Circuit: a Bench-to-bedside Study

Conditions
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Non-invasive Ventilation

Intervention / Treatment
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* Device: external gas during NIV


Participation Criteria
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Eligibility Criteria
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Inclusion 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). Exclusion Criteria: Patients with underlying psychiatric disease were excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| one group<br>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) | Device: external gas during NIV<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asynchronies ( yes or no) | Presence of asynchronies identify by SOMNONIV´s algorithm during the gas treatment with NIV | 1 day | 
| Type of asynchronies | autotrigger or innefective effort identify by SOMNONIV´s group algorithm, during the gas treatment with NIV | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of asynchronies pre | autotrigger or innefectuve effort identify by SOMNONIV´s group pre gas during NIV treatment | 1 day | 
| Type of asynchronies post | autotrigger or innefective effort identify by SOMNONIV´s group algorithm, , post gas during NIV | 1 day | 
| Asynchronies ( yes or no) pre | Presence of asynchronies identify by SOMNONIV´s algorithm during pre-gas treatment with NIV | 1 day | 
| Asynchronies ( yes or no) post | Presence of asynchronies identify by SOMNONIV´s algorithm during the post gas treatment with NIV | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive Ventilation, trigger asynchronies, autotriggering, bench study