Non Invasive Ventilation on Healthy Volunteer, Respiratory Failure
Conditions
Keywords
Non invasive ventilation, Helmet, NEXT Helmet, Work of breathing, Intensive care
Brief summary
Noninvasive ventilation (NIV) is a well established, safe, and effective technique in improving gas exchange while reducing dyspnea and inspiratory effort in patients with either hypoxemic and hypercapnic acute respiratory failure (ARF) and averts the risk secondary to endotracheal intubation.Crucial factors for NIV success, in any forms of respiratory failure, are the tolerance to the interface used and the ability of the interface to unload inspiratory-muscle. Helmet is better tolerated over time, allowing continuous application of NIV for longer periods, while face mask has been proved to be more efficient at iso-support in unloading the respiratory muscles and improving patient-ventilator synchrony. Helmet NEXT (CaStar, NIV model, Starmed, Mirandola, Italy) is a novel type of helmet with a better compliant wall, that avoid the use of armpit braces potentially improving, compared to the standard helmet, both pressurization and patient-ventilator interaction and tolerance. The objective of this study is to compare the effects of NIV delivered via face mask, standard helmet, and NEXT helmet in terms of work of breathing, patient-ventilator interaction, and comfort.
Detailed description
16 Healthy volunteers will be enrolled. They will be ventilated with non invasive ventilation. The Work of breathing, ventilator/patient asynchrony, and ventilatory comfort produced between face mask, Helmet and NEXT helmet will be compared.
Interventions
DEVICENon invasive ventilation HELMET
The HELMET and HELMET NEXT modes will be tested by each patient.
DEVICENon invasive ventilation facemask (Respironics)
The facemask Respironics (Herrsching, Germany) will be used by each patient.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers
Exclusion criteria
* contraindications for nasogastric tube placement * Respiratory disease * Pregnancy * No French health insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Work of breathing | during the single visit study (day 1) | To estimate the work of breathing, we will determine the swings in transdiaphragmatic pressure (Pdi) and the transdiaphragmatic pressure-time product (PTPdi) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilatory comfort | during the single visit study (day 1) | The comfort will be assessed by a self-assessment of the patient on a visual analog scale between 0 (excellent) and 10 (discomfort). |
| Patient-ventilator asynchronies | during the single visit study (day 1) | The patient-ventilator asynchronies will be assessed by the asynchronie index (number of asynchronies / number of respiratory cycles). The number of asynchronies will be assessed by the investigator, on the records of the pression curves and the respiratory outputs. |
| Ventilatory parameters | during the single visit study (day 1) | The respiratory frequency and current volume will be measured. |
Countries
France
Outcome results
None listed