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NCT Number: NCT01610960

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, 34000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

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

Treatment and study plan

Non invasive ventilation HELMET

Device

The HELMET and HELMET NEXT modes will be tested by each patient.

Non invasive ventilation facemask (Respironics)

Device

The facemask Respironics (Herrsching, Germany) will be used by each patient.

Primary outcomes

  1. Work of breathing

    Time frame: 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 outcomes

  1. Ventilatory comfort

    Time frame: 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).

  2. Patient-ventilator asynchronies

    Time frame: 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.

  3. Ventilatory parameters

    Time frame: during the single visit study (day 1)

    The respiratory frequency and current volume will be measured.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 4, 2012
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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