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

Respiratory Failure Clinical Trial

Official title:

Comparison of Helmet NEXT, Helmet Standard and Facemask for Noninvasive Ventilation: a Physiological Study in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610960
• Other study ID #: 8937
• Status: Completed
• Phase: N/A
• First received: May 24, 2012
• Last updated: May 30, 2013
• Start date: April 2012
• Est. completion date: August 2012

Study information

• Verified date: May 2012
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• contraindications for nasogastric tube placement

• Respiratory disease

• Pregnancy

• No French health insurance

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Non Invasive Ventilation on Healthy Volunteer
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Non invasive ventilation HELMET
The HELMET and HELMET NEXT modes will be tested by each patient.
• Non invasive ventilation facemask (Respironics)
The facemask Respironics (Herrsching, Germany) will be used by each patient.

Locations

Country	Name	City	State
France	Department of Anesthesiology & Critical Care, St Eloi University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work of breathing	To estimate the work of breathing, we will determine the swings in transdiaphragmatic pressure (Pdi) and the transdiaphragmatic pressure-time product (PTPdi)	during the single visit study (day 1)	No
Secondary	Ventilatory comfort	The comfort will be assessed by a self-assessment of the patient on a visual analog scale between 0 (excellent) and 10 (discomfort).	during the single visit study (day 1)	No
Secondary	Patient-ventilator asynchronies	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.	during the single visit study (day 1)	No
Secondary	Ventilatory parameters	The respiratory frequency and current volume will be measured.	during the single visit study (day 1)	No