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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03821311
Acronym
INVENT
Enrollment
8
Registered
2019-01-29
Start date
2018-12-06
Completion date
2019-06-18
Last updated
2019-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

RADIATIONComputed 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.

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

It's a prospective, single-center, pilot, pathophysiological study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Gas trapping (expressed as percent total lung volume)30 minutes

Secondary

MeasureTime frameDescription
Regional lung ventilation distribution30 minutesRegional change in attenuation between end-expiration and end-inspiration, based on CT image
Coefficient of variation of regional lung ventilation30 minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026