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

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ClinicalTrials.gov Identifier: NCT03821311
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : December 27, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Nasal High Flow Dynamic Volumetric Computed Tomography Radiation: Computed tomography Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: It's a prospective, single-center, pilot, pathophysiological study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Effect of Nasal High Flow Oxygen Therapy on Regional Lung Function
Actual Study Start Date : December 6, 2018
Actual Primary Completion Date : June 18, 2019
Actual Study Completion Date : June 18, 2019

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Arms and Interventions
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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 Name: CT


Outcome Measures
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Primary Outcome Measures :
  1. Gas trapping (expressed as percent total lung volume) [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821311


Locations
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France
University Hospital Grenoble
Grenoble, Isère, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
More Information
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Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03821311    
Other Study ID Numbers: 38RC17.376
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: December 27, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases