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

High Flow Nasal Cannula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091504
• Other study ID #: BDTHFNC01
• Status: Completed
• Phase: N/A
• First received: March 15, 2017
• Last updated: April 2, 2018
• Start date: September 4, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2018
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Chronic obstructive pulmonary disease or asthma patients who have positive response in bronchodilator test will be consented and enrolled, patients come back for the second bronchodilator assessment within one to three days after the initial bronchodilator test. Albuterol with different concentration will be provided to the patients via HFNC, patients will be assessed by spirometry after each concentration until bronchodilator response is positive and does not improve after the next dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• High Flow Nasal Cannula

Intervention

Device:
• High flow nasal cannula
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.

Drug:
• Albuterol Sulfate
Albuterol is a short acting inhaled bronchodilator

Locations

Country	Name	City	State
China	People's Hospital of Xinjiang Uygur Autonomous Region	Ürümqi	Xinjiang

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	People's Hospital of Xinjiang Uygur Autonomous Region

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Morgan SE, Mosakowski S, Solano P, Hall JB, Tung A. High-Flow Nasal Cannula and Aerosolized ß 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. — View Citation

Réminiac F, Vecellio L, Heuzé-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. — View Citation

Réminiac 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 change from initial	FEV1 abs ?: post FEV 1 - pre FEV1 and FEV1 %?init: (post FEV1 - pre FEV1)/pre FEV1 × 100	30-60 mins
Secondary	Breath sound	Wheezing	30-60 mins
Secondary	Heart rate	The number of heart beats per minute	30-60 mins
Secondary	Respiratory rate	About 4,630,000 results (0.68 seconds); Search Results; The number of breaths per minute	30-60 mins
Secondary	Side effects	Tremor	30-60 mins