Skip to main content
OpenTrials
Completed

NCT Number: NCT03821311

Investigating the Effect of Nasal High Flow Oxygen Therapy on Regional Lung Function

This study aims to assess the effect of nasal high flow oxygen therapy on regional function measured by volumetric computed tomography, in patients with chronic obstructive pulmonary disease.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Grenoble

Grenoble, Isère, 38000, France

About this study

Nasal high flow (NHF) is a non-invasive breathing therapy that is based on the delivery of heated and humidified air at flow rates that exceed peak inspiratory flow, via a large-caliber nasal cannula. It delivers a fraction of inspired oxygen (FiO2) from 21% to 100%, with a flow rate up to 60 L·min-1.

The therapy is used for a variety of disease conditions including chronic obstructive pulmonary disease (COPD). Patients with COPD frequently manifest flow limitation during resting tidal breathing, through dynamic compression of the airways, which is attributed to a loss of parenchymal tethering of the airways. In patients with severe COPD and respiratory failure, improved oxygenation and ventilation may reduce mortality. There are limited clinical data available in adult applications of NHF and on the effectiveness of NHF in patients with stable moderate or severe COPD.

The mechanisms through which NHF affects the respiratory system are still being investigated. Two of the proposed mechanisms of action of NHF therapy are the generation of 3-5 cmH20 positive airway pressure during expiration and washout of the nasopharyngeal dead space. Positive airway pressure has been shown to improve oxygenation, ventilation-perfusion matching and respiratory rates, while nasopharyngeal washout reduces the anatomical dead space and thereby improves alveolar ventilation.

Our working hypothesis is that positive nasopharyngeal pressure generated by NHF particularly during expiration can help maintain small peripheral airways patent, thereby reducing the amount of gas trapping.

Gas trapping can be quantified based on densitometric analysis of registered computerized tomography images obtained at high and low lung volumes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Stable, moderate to severe COPD, defined as follows:

Moderate: FEV1/FVC < 0.7 or lower limit of normal, and 30 < FEV1 ≤ 60 percent predicted; Severe: FEV1/FVC < 0.7 or lower limit of normal, and FEV1 ≤ 30 percent predicted

  • Indication for CT imaging as part of routine workup.
  • Written informed consent signed

Exclusion criteria

  • Acute disease condition such as infection, respiratory or cardiac failure
  • Persons referred to in Articles L1151-5 to L1151-8 and L1122-1-2 of the French Public Health Code: Declared pregnant, parturient or lactating, persons deprived of their liberty by judicial or administrative decision, minors, adults who are legally protected or unable to express consent, etc.
  • Evolving neoplastic disease
  • Patient without social security health care coverage
  • Subject in an exclusion period from another study
  • Any contraindication to NHF such as nasal or upper airway bleeding, secretion, tumor, recent surgery; cervical, nasal or skull fracture.

Treatment and study plan

computed tomography

Radiation

End-inspiratory/end-expiratory CT is repeated 3 times corresponding to the 3 studied conditions: At baseline, through expiratory resistive loading using an adjustable PEP mask, and after 5 min of nasal high flow therapy at 25 L/min.

Other names: CT

Primary outcomes

  1. Gas trapping (expressed as percent total lung volume)

    Time frame: 30 minutes

Secondary outcomes

  1. Regional lung ventilation distribution

    Time frame: 30 minutes

    Regional change in attenuation between end-expiration and end-inspiration, based on CT image

  2. Coefficient of variation of regional lung ventilation

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: INVENT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2019
Registry last updated
Dec 27, 2019

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.

Published trials that share one or more normalized conditions with this study.