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

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

Sponsors

Lead sponsor: Rush University Medical Center

Collaborator: People's Hospital of Xinjiang Uygur Autonomous Region

Source Rush University Medical Center
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.

Detailed 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.

Overall Status Completed
Start Date September 4, 2017
Completion Date March 31, 2018
Primary Completion Date March 31, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
FEV1 change from initial 30-60 mins
Secondary Outcome
Measure Time Frame
Breath sound 30-60 mins
Heart rate 30-60 mins
Respiratory rate 30-60 mins
Side effects 30-60 mins
Enrollment 42
Condition
Intervention

Intervention type: Device

Intervention name: High flow nasal cannula

Description: 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.

Arm group label: Albuterol via High flow nasal cannula

Other name: Optiflow, Fisher Paykel

Intervention type: Drug

Intervention name: Albuterol Sulfate

Description: Albuterol is a short acting inhaled bronchodilator

Arm group label: Albuterol via High flow nasal cannula

Other name: Ventolin

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Minghua Zhao, MD Principal Investigator People's Hospital of Xinjiang Uygur Autonomous Region
Location
facility
People's Hospital of Xinjiang Uygur Autonomous Region
Location Countries

China

Verification Date

April 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Rush University Medical Center

Investigator full name: Jie Li

Investigator title: Principal Investigator

Has Expanded Access No
Number Of Arms 1
Arm Group

Arm group label: Albuterol via High flow nasal cannula

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov