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Not yet recruiting NCT06939920

NIV With Airway Washout for Dual Limb Ventilation: Improvement in Minute Ventilation

No phase Interventional Respiratory Failure Requiring Non Invasive Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-invasive ventilation mask with airway washout, non-invasive ventilation.
Who it may be relevant to
Registry conditions: Respiratory Failure Requiring Non Invasive Ventilation. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This is a prospective, non-randomized, non-blinded, crossover feasibility investigation to assess the safety, usability, and efficacy of the investigational mask in the hospital environment. Eligible patients that are stable in NIV and able to give informed consent will be approached and if they consent the patient will be included in the study. If potential participants decline, normal hospital care will be continued. The enrolled participant will receive NIV on the commercially available Visairo mask for one hour during which their ventilatory parameters will be logged. Then the participant will be switched to the investigational mask for another hour. The ventilator data will be collected for these two hours. At the end of the intervention the participant will be reverted to their original mask. The medical staff will be asked to fill out the case report form pertaining to the function and usability of the investigational mask compared to the conventional mask.

Detailed description

In an acute setting, Non-invasive ventilation (NIV) is a method of delivering respiratory support without using an endotracheal tube. It's a first-line treatment for specific conditions like COPD exacerbations and acute cardiogenic pulmonary edema. NIV aims to improve gas exchange, reduce work of breathing, avoid intubation, and reduce complications.

For patients with COPD exacerbations and acute cardiogenic pulmonary edema NIV is a first line therapy. NIV is also considered for other conditions like acute respiratory failure due to asthma exacerbation and in immunocompromised individuals with acute respiratory insufficiency. Additionally, it can be used in post-operative respiratory failure, for difficult weaning, and to prevent post-extubation failure.

NIV has been shown to result in overall better outcomes than mechanical ventilation with reduced mortality and morbidity, fewer ICU acquired infections improved lung function and shorter ICU stays. The severity of the respiratory insufficiency influences the likelihood of successful NIV. One factor associated with respiratory sufficiency is respiratory dead space. This is the volume in the respiratory apparatus that does not partake in gas exchange and in the ventilated patient includes the volume in the equipment, the conductive airways and pathological respiratory tissue. A high dead-space fraction early in the course of the illness is association with increased risk of death.9 Particularly in patients that have a small tidal volume and high respiratory rate, or patients with an increased physiological dead space due to lung disease, a change in instrumental dead space can have a large impact on alveolar minute ventilation. Improved alveolar ventilation can improve CO2 elimination and help to reduce respiratory acidosis as well as improve oxygen delivery.10, 11 This can consequently reduce the respiratory effort required by the patient. 12 If the physician instead chooses to keep arterial CO2 concentration (PaCO2) constant, a reduction of instrumental dead space will allow a reduction of tidal volume, plateau pressure, driving pressure, or a reduction of the respiratory rate and thus a reduction in work of breathing.

NIV with washout improves ventilation compared to conventional NIV by reducing expired air in each breath. This may result in faster normalization of ventilatory gasses and a reduced work of breathing, the patient may improve more rapidly as alveolar ventilation is improved. Or, allow for a reduction in pressure for similar ventilatory benefits, potentially improving NIV tolerance and therapy adherence. In stable COPD patients, NIV with Airway Washout resulted in a significant reduction in minute ventilation compared to conventional NIV. This was approximately 19% lower with OptiNIV compared to conventional NIV.15 In this study minute ventilation will be calculated from the RR and Vt retrieved from the ventilator to asses improvement in ventilation over the study period, this feasibility pilot aims to establish efficacy of airway washout and whether the increased leak required for dead space flushing does not impact safety, usability and performance. When airway washout for dual limb ventilators becomes widely available it may improve NIV therapy efficacy by improving ventilation or reducing the pressure needed for a similar level of ventilatory support.

Interventions

  • Other Non-invasive ventilation mask with airway washout
    Non-invasive ventilation mask with airway washout for dual limb ventilators
  • Other non-invasive ventilation
    standard state of the art non-invasive ventilation

Primary outcome measures

  • minute ventilation [Time frame: The first 5 minutes on each mask will be compared to the last 5 minutes on the same mask and the differences compared by paired T-test.]
Secondary outcome measures (5)
  • Ventilator data (pressure) [Time frame: Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.]
  • Ventilator data (flow) [Time frame: Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.]
  • user feedback [Time frame: once both arms are completed, right after the 2 hours on NIV]
  • Ventilator data (leak) [Time frame: Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.]
  • Ventilator data (alarms) [Time frame: Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.]

Eligibility criteria

Inclusion criteria

  • Adults admitted to the ICU prescribed NIV and stable
  • Able to receive therapy on a sub-nasal (under-the-nose) mask
  • Are 18 years old or older

Exclusion criteria

  • Contraindicated for NIV
  • NIV is likely to fail and/or intubation be required, at the medical staff's discretion
  • Bilevel pressure of ≥ 30 cmH2O required
  • Do not fit the investigational mask or the standard mask
  • Pregnancy (tested under standard care)
  • Unable to tolerate NIV for the duration of the investigation
  • Agitated
  • Unable to understand the consent process

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06939920 · Fisher and Paykel Healthcare

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗