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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Nasal High Flow, Dynamic Volumetric Computed Tomography

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Computed tomography
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Grenoble

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computed tomography examination

Arm Description

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.

Outcomes

Primary Outcome Measures

Gas trapping (expressed as percent total lung volume)

Secondary Outcome Measures

Regional lung ventilation distribution
Regional change in attenuation between end-expiration and end-inspiration, based on CT image
Coefficient of variation of regional lung ventilation

Full Information

First Posted
December 17, 2018
Last Updated
December 26, 2019
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03821311
Brief Title
Investigating the Effect of Nasal High Flow Oxygen Therapy on Regional Lung Function
Acronym
INVENT
Official Title
Investigating the Effect of Nasal High Flow Oxygen Therapy on Regional Lung Function
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 6, 2018 (Actual)
Primary Completion Date
June 18, 2019 (Actual)
Study Completion Date
June 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Nasal High Flow, Dynamic Volumetric Computed Tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
It's a prospective, single-center, pilot, pathophysiological study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computed tomography examination
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Computed tomography
Other Intervention Name(s)
CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gas trapping (expressed as percent total lung volume)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Regional lung ventilation distribution
Description
Regional change in attenuation between end-expiration and end-inspiration, based on CT image
Time Frame
30 minutes
Title
Coefficient of variation of regional lung ventilation
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
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Investigating the Effect of Nasal High Flow Oxygen Therapy on Regional Lung Function

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