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

December 26, 2019 updated by: University Hospital, Grenoble
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Isère
      • Grenoble, Isère, France, 38000
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computed tomography examination
Each patient will undergo a low-dose supine position chest CT scan including end-inspiratory and expiratory acquisitions, corresponding to the routine protocol for COPD patients, except that this end-inspiratory/end-expiratory CT is repeated 3 times for total of 6 CT acquisitions.
Radiation: Computed tomography
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gas trapping (expressed as percent total lung volume)
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional lung ventilation distribution
Time Frame: 30 minutes
Regional change in attenuation between end-expiration and end-inspiration, based on CT image
30 minutes
Coefficient of variation of regional lung ventilation
Time Frame: 30 minutes
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2018

Primary Completion (Actual)

June 18, 2019

Study Completion (Actual)

June 18, 2019

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 29, 2019

Study Record Updates

Last Update Posted (Actual)

December 27, 2019

Last Update Submitted That Met QC Criteria

December 26, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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