Comparison of Three Noninvasive Ventilation Modes: a Physiological Study in Healthy Volunteers

Not Applicable

Completed

• Conditions: Respiratory Failure; Non Invasive Ventilation on Healthy Volunteer
• Interventions: Device: Non invasive ventilation HELMET; Device: Non invasive ventilation facemask (Respironics)

• Registration Number: NCT01610960
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2012-04
• Status Verified: 2012-05
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-06-01
• Study First Posted: 2012-06-04
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• contraindications for nasogastric tube placement
• Respiratory disease
• Pregnancy
• No French health insurance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HELMET	Non invasive ventilation HELMET	The HELMET and HELMET NEXT modes will be tested by each patient.
Facemask	Non invasive ventilation facemask (Respironics)	The facemask will be used by each patient.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Anesthesiology & Critical Care, St Eloi University Hospital; 🇫🇷 Montpellier, France