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

Not Applicable

Completed

• Conditions: High Flow Nasal Cannula
• Interventions: Device: High flow nasal cannula; Drug: Albuterol Sulfate

• Registration Number: NCT03091504
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Study Start: 2017-09-04
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Albuterol via High flow nasal cannula	High flow nasal cannula	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.
Albuterol via High flow nasal cannula	Albuterol Sulfate	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.

Primary Outcome Measures

Name	Time	Method
FEV1 change from initial	30-60 mins	FEV1 abs Δ: post FEV 1 - pre FEV1 and FEV1 %Δinit: (post FEV1 - pre FEV1)/pre FEV1 × 100

Secondary Outcome Measures

Name	Time	Method
Respiratory rate	30-60 mins	About 4,630,000 results (0.68 seconds); Search Results; The number of breaths per minute
Breath sound	30-60 mins	Wheezing
Heart rate	30-60 mins	The number of heart beats per minute
Side effects	30-60 mins	Tremor

Trial Locations

Locations (1)

People's Hospital of Xinjiang Uygur Autonomous Region; 🇨🇳 Ürümqi, Xinjiang, China