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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Dynamic Volumetric Computed Tomography; Nasal High Flow
• Interventions: Radiation: Computed tomography

• Registration Number: NCT03821311
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2018-12-06
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-29
• Primary Completion: 2019-06-18
• Study Completion: 2019-06-18
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Computed tomography examination	Computed tomography	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.

Primary Outcome Measures

Name	Time	Method
Gas trapping (expressed as percent total lung volume)	30 minutes

Secondary Outcome Measures

Name	Time	Method
Regional lung ventilation distribution	30 minutes	Regional change in attenuation between end-expiration and end-inspiration, based on CT image
Coefficient of variation of regional lung ventilation	30 minutes

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, Isère, France