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

NCT03821311 | Completed

• 1 other identifier: 38RC17.376
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Gas trapping (expressed as percent total lung volume)

  30 minutes

Secondary Outcomes (2)

• Regional lung ventilation distribution

  30 minutes

• Coefficient of variation of regional lung ventilation

  30 minutes

Study Arms (1)

Computed tomography examination

EXPERIMENTAL

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

Interventions

Computed tomography RADIATION

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.

Also known as: CT

Computed tomography examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Any contraindication to NHF such as nasal or upper airway bleeding, secretion, tumor, recent surgery; cervical, nasal or skull fracture.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, Isère, 38000, France

Location

Related Publications (15)

• Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.

  PMID: 22878278 BACKGROUND

• Stubbing DG, Pengelly LD, Morse JL, Jones NL. Pulmonary mechanics during exercise in subjects with chronic airflow obstruction. J Appl Physiol Respir Environ Exerc Physiol. 1980 Sep;49(3):511-5. doi: 10.1152/jappl.1980.49.3.511.

  PMID: 7204175 BACKGROUND

• Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

  PMID: 25981908 BACKGROUND

• Pisani L, Vega ML. Use of Nasal High Flow in Stable COPD: Rationale and Physiology. COPD. 2017 Jun;14(3):346-350. doi: 10.1080/15412555.2017.1315715. Epub 2017 May 1.

  PMID: 28459282 BACKGROUND

• Curley GF, Laffy JG, Zhang H, Slutsky AS. Noninvasive respiratory support for acute respiratory failure-high flow nasal cannula oxygen or non-invasive ventilation? J Thorac Dis. 2015 Jul;7(7):1092-7. doi: 10.3978/j.issn.2072-1439.2015.07.18. No abstract available.

  PMID: 26380720 BACKGROUND

• Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.

  PMID: 21908497 BACKGROUND

• Riera J, Perez P, Cortes J, Roca O, Masclans JR, Rello J. Effect of high-flow nasal cannula and body position on end-expiratory lung volume: a cohort study using electrical impedance tomography. Respir Care. 2013 Apr;58(4):589-96. doi: 10.4187/respcare.02086.

  PMID: 23050520 BACKGROUND

• Spahija J, de Marchie M, Grassino A. Effects of imposed pursed-lips breathing on respiratory mechanics and dyspnea at rest and during exercise in COPD. Chest. 2005 Aug;128(2):640-50. doi: 10.1378/chest.128.2.640.

  PMID: 16100149 BACKGROUND

• O'Donnell DE, Sanii R, Anthonisen NR, Younes M. Expiratory resistive loading in patients with severe chronic air-flow limitation. An evaluation of ventilatory mechanics and compensatory responses. Am Rev Respir Dis. 1987 Jul;136(1):102-7. doi: 10.1164/ajrccm/136.1.102.

  PMID: 3605825 BACKGROUND

• Mueller RE, Petty TL, Filley GF. Ventilation and arterial blood gas changes induced by pursed lips breathing. J Appl Physiol. 1970 Jun;28(6):784-9. doi: 10.1152/jappl.1970.28.6.784. No abstract available.

  PMID: 5419502 BACKGROUND

• Galban CJ, Han MK, Boes JL, Chughtai KA, Meyer CR, Johnson TD, Galban S, Rehemtulla A, Kazerooni EA, Martinez FJ, Ross BD. Computed tomography-based biomarker provides unique signature for diagnosis of COPD phenotypes and disease progression. Nat Med. 2012 Nov;18(11):1711-5. doi: 10.1038/nm.2971. Epub 2012 Oct 7.

  PMID: 23042237 BACKGROUND

• Fricke K, Tatkov S, Domanski U, Franke KJ, Nilius G, Schneider H. Nasal high flow reduces hypercapnia by clearance of anatomical dead space in a COPD patient. Respir Med Case Rep. 2016 Aug 26;19:115-7. doi: 10.1016/j.rmcr.2016.08.010. eCollection 2016.

  PMID: 27668173 BACKGROUND

• Kybic J, Unser M. Fast parametric elastic image registration. IEEE Trans Image Process. 2003;12(11):1427-42. doi: 10.1109/TIP.2003.813139.

  PMID: 18244700 BACKGROUND

• Gibson GJ, Loddenkemper R, Lundback B, Sibille Y. Respiratory health and disease in Europe: the new European Lung White Book. Eur Respir J. 2013 Sep;42(3):559-63. doi: 10.1183/09031936.00105513. No abstract available.

  PMID: 24000245 BACKGROUND

• Cohen JG, Broche L, Machichi M, Ferretti GR, Tamisier R, Pepin JL, Bayat S. Nasal High Flow at 25 L/min or Expiratory Resistive Load Do Not Improve Regional Lung Function in Patients With COPD: A Functional CT Imaging Study. Front Physiol. 2021 Jun 10;12:683316. doi: 10.3389/fphys.2021.683316. eCollection 2021.

  PMID: 34177626 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: January 29, 2019
• Study Start: December 6, 2018
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)