Evaluation on the Efficacy of Bronchodilator Nebulization Via High Flow Nasal Cannula

NCT03091504 | Completed DMC

• 1 other identifier: BDTHFNC01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

High-humidity nasal cannula (HFNC) has been shown to be effective in improving oxygenation and avoiding intubation in multiple randomized control trials, it is also suitable and feasible for long term use. Aerosol delivery via HFNC will minimize interruptions and improve patient compliance, bench study and radionuclide imaging study done in healthy volunteers demonstrated that aerosol can be effectively delivered using HFNC. This study aims to evaluate the efficacy of bronchodilator delivered via HFNC in chronic pulmonary obstructive disease or asthma patients.

Conditions

High Flow Nasal Cannula

Outcome Measures

Primary Outcomes (1)

• FEV1 change from initial

  FEV1 abs Δ: post FEV 1 - pre FEV1 and FEV1 %Δinit: (post FEV1 - pre FEV1)/pre FEV1 × 100

  30-60 mins

Secondary Outcomes (4)

• Breath sound

  30-60 mins

• Heart rate

  30-60 mins

• Respiratory rate

  30-60 mins

• Side effects

  30-60 mins

Study Arms (1)

Albuterol via High flow nasal cannula

EXPERIMENTAL

Enrolled patients inhale bronchodilator (Albuterol Sulfate) with different concentration via High flow nasal cannula, prepared albuterol concentrations are 0.5mg, 1.0mg, 2.0mg and 4.0mg, patients will be assessed by spirometry after each concentration until bronchodilator response is positive and does not improve after the next dose.

Device: High flow nasal cannula; Drug: Albuterol Sulfate

Interventions

High flow nasal cannula DEVICE

High flow nasal cannula is a soft and flexible nasal prongs with adjustable head strap fits over the patient's ears, it delivers a broad variety of gas flows directly into the nares without gas jetting.

Also known as: Optiflow, Fisher Paykel

Albuterol via High flow nasal cannula

Albuterol Sulfate DRUG

Albuterol is a short acting inhaled bronchodilator

Also known as: Ventolin

Albuterol via High flow nasal cannula

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnose with COPD or asthma
• Bronchodilator test is positive (According to ATS guidelines, FEV1 change from initial more than 12% and FEV1 absolute change more than 200 mL);
• Age \> 18yrs and \< 90yrs

You may not qualify if:

• Recent pulmonary exacerbation
• Mental disease
• Uncooperative
• Reluctant to participate
• Patients who are unable to come back to get the second spirometry within three days
• Contraindicated to Albuterol (Ventolin, GSK)
• Rest HR \> 100 beats/min
• Serum K+ \< 2.8 mmol/L

Sponsors & Collaborators

• Rush University Medical Center: lead
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator

Study Sites (1)

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

Location

Related Publications (6)

• Dailey PA, Harwood R, Walsh K, Fink JB, Thayer T, Gagnon G, Ari A. Aerosol Delivery Through Adult High Flow Nasal Cannula With Heliox and Oxygen. Respir Care. 2017 Sep;62(9):1186-1192. doi: 10.4187/respcare.05127. Epub 2017 Jun 6.

  PMID: 28588117 BACKGROUND

• Reminiac F, Vecellio L, Heuze-Vourc'h N, Petitcollin A, Respaud R, Cabrera M, Pennec DL, Diot P, Ehrmann S. Aerosol Therapy in Adults Receiving High Flow Nasal Cannula Oxygen Therapy. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):134-41. doi: 10.1089/jamp.2015.1219. Epub 2015 Jul 21.

  PMID: 26196740 BACKGROUND

• Dugernier J, Hesse M, Jumetz T, Bialais E, Roeseler J, Depoortere V, Michotte JB, Wittebole X, Ehrmann S, Laterre PF, Jamar F, Reychler G. Aerosol Delivery with Two Nebulizers Through High-Flow Nasal Cannula: A Randomized Cross-Over Single-Photon Emission Computed Tomography-Computed Tomography Study. J Aerosol Med Pulm Drug Deliv. 2017 Oct;30(5):349-358. doi: 10.1089/jamp.2017.1366. Epub 2017 May 2.

  PMID: 28463044 BACKGROUND

• Reminiac F, Vecellio L, Loughlin RM, Le Pennec D, Cabrera M, Vourc'h NH, Fink JB, Ehrmann S. Nasal high flow nebulization in infants and toddlers: An in vitro and in vivo scintigraphic study. Pediatr Pulmonol. 2017 Mar;52(3):337-344. doi: 10.1002/ppul.23509. Epub 2016 Jul 8.

  PMID: 27392199 BACKGROUND

• Morgan SE, Mosakowski S, Solano P, Hall JB, Tung A. High-Flow Nasal Cannula and Aerosolized beta Agonists for Rescue Therapy in Children With Bronchiolitis: A Case Series. Respir Care. 2015 Sep;60(9):e161-5. doi: 10.4187/respcare.03996. Epub 2015 Jun 23.

  PMID: 26106204 BACKGROUND

• Baudin F, Buisson A, Vanel B, Massenavette B, Pouyau R, Javouhey E. Nasal high flow in management of children with status asthmaticus: a retrospective observational study. Ann Intensive Care. 2017 Dec;7(1):55. doi: 10.1186/s13613-017-0278-1. Epub 2017 May 22.

  PMID: 28534235 BACKGROUND

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Minghua Zhao, MD

  People's Hospital of Xinjiang Uygur Autonomous Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 27, 2017
• Study Start: September 4, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: April 4, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)