The Role of Gas Flow in Transnasal Pulmonary Aerosol Delivery: A Double-blinded, Randomized Controlled Trial

NCT03739359 | Completed

• 1 other identifier: HFNC-PFT-002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Aerosol delivery via nasal cannula has gained increasing popularity, due to its combined benefits from aerosolized medication and heated warm oxygen therapy. In our previous in vitro study, we investigated the effects of the ratio of nasal cannula gas flow to subject's peak inspiratory flow (GF: IF) on the aerosol lung deposition, and we found that aerosol deposition in lung increased as the GF: IF decreased with an optimal GF: IF between 0.1 to 0.5 producing a stable "lung" deposition in both quiet and distress breathing. Thus we aimed to further validate such an optimal GF: IF in patients with reversible airflow limitations by the delivery of bronchodilators. Adult COPD or asthma patients who met ATS/ERS criteria for bronchodilator response in pulmonary function lab will be recruited and consented. After a washout period (1-3 days), patients will receive an escalating doubling dosage (0.5, 1, 2, and 4mg) of albuterol in total volume of 2mL, delivered by mesh nebulizer via nasal cannula. Patients will be randomly assigned to inhale bronchodilator into 3 group using different flows: 50 L/min,GF: IF = 1.0, and GF: IF = 0.5.

Conditions

COPD Asthma

Keywords

Nasal cannula; Aerosol therapy; Gas flow

Outcome Measures

Primary Outcomes (4)

• The number of patients who meet the positive criteria of responding to albuterol at the dose of 0.5mg

  The number of patients in HFNC nebulization who respond to albuterol at the dose of 0.5mg

  30 minutes

• The number of patients who meet the positive criteria of responding to albuterol at the dose of 1.5 mg

  The number of patients in HFNC nebulization who respond to albuterol at the dose of 1.5mg

  60 minutes

• The number of patients who meet the positive criteria of responding to albuterol at the dose of 3.5 mg

  The number of patients in HFNC nebulization who respond to albuterol at the dose of 3.5mg

  90 minutes

• The number of patients who meet the positive criteria of responding to albuterol at the dose of 7.5mg

  The number of patients in HFNC nebulization who respond to albuterol at the dose of 7.5mg

  120 minutes

Secondary Outcomes (3)

• the accumulative dose of albuterol required across groups to produce positive bronchodilation effects

  120 minutes

• the incidence of side effect (tachycardia) in each group

  120 minutes

• the incidence of side effect (tremor) in each group

  120 minutes

Study Arms (3)

Gas flow 50 L/min

ACTIVE COMPARATOR

In this group, nasal cannula gas flow will be set at 50 L/min.

Other: nasal cannula gas flow

GF:IF=1

EXPERIMENTAL

In this group, nasal cannula gas flow will be set at each individual patient's own inspiratory flow (GF:IF=1)

Other: nasal cannula gas flow

GF:IF=0.5

EXPERIMENTAL

In this group, nasal cannula gas flow will be set at 50% of each individual patient's own inspiratory flow (GF:IF=0.5)

Other: nasal cannula gas flow

Interventions

nasal cannula gas flow OTHER

High flow nasal cannula (HFNC) is a relatively new oxygen device, which provides warmed and humidified oxygen for patients. When patients need to inhale aerosolized medication during HFNC, the nebulizer will be placed in-line in order to provide both treatments. This study will investigate the influence of three flow settings (50 L/min, GF:IF=1, GF:IF=0.5) on the clinical effects of nebulization.

GF:IF=0.5; GF:IF=1; Gas flow 50 L/min

Eligibility Criteria

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

You may qualify if:

• Adult patients with positive bronchodilator responses to four actuations of albuterol (Ventolin, GSK, UK) via MDI with VHC (OptiChamber Diamond, Philips, USA) will be eligible for enrollment. A positive bronchodilator response is defined in accordance with ATS/ERS guidelines as follows: an increase in FEV1 of ≥ 12% and absolute change ≥ 200 mL from baseline.

You may not qualify if:

• age ≥ 90 years old;
• pregnancy;
• pulmonary exacerbation within two weeks before enrollment;
• reluctant to participate;
• inability to complete the follow-up spirometry after each bronchodilator inhalation;
• resting heart rate \> 100bpm;
• resting systolic blood pressure \> 160mmHg or diastolic blood pressure \> 110mmHg.

Sponsors & Collaborators

• Rush University Medical Center: lead
• People's Liberation Army General Hospital: collaborator

Study Sites (1)

People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (6)

• Zhu Y, Yin H, Zhang R, Wei J. High-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients with acute respiratory failure: a systematic review and meta-analysis of randomized controlled trials. BMC Pulm Med. 2017 Dec 13;17(1):201. doi: 10.1186/s12890-017-0525-0.

  PMID: 29237436 RESULT

• Braunlich J, Wirtz H. Oral Versus Nasal High-Flow Bronchodilator Inhalation in Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2018 Aug;31(4):248-254. doi: 10.1089/jamp.2017.1432. Epub 2017 Dec 20.

  PMID: 29261402 RESULT

• Gacouin A, Maamar A, Fillatre P, Sylvestre E, Dolan M, Le Tulzo Y, Tadie JM. Patients with preexisting psychiatric disorders admitted to ICU: a descriptive and retrospective cohort study. Ann Intensive Care. 2017 Dec;7(1):1. doi: 10.1186/s13613-016-0221-x. Epub 2017 Jan 3.

  PMID: 28050894 RESULT

• Ammar MA, Sasidhar M, Lam SW. Inhaled Epoprostenol Through Noninvasive Routes of Ventilator Support Systems. Ann Pharmacother. 2018 Dec;52(12):1173-1181. doi: 10.1177/1060028018782209. Epub 2018 Jun 12.

  PMID: 29890848 RESULT

• 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 RESULT

• Li J, Luo J, Chen Y, Xie L, Fink JB. Effects of flow rate on transnasal pulmonary aerosol delivery of bronchodilators via high-flow nasal cannula for patients with COPD and asthma: protocol for a randomised controlled trial. BMJ Open. 2019 Jun 24;9(6):e028584. doi: 10.1136/bmjopen-2018-028584.

  PMID: 31239304 DERIVED

Study Officials

• Lixing Xie, MD

  People's Liberation Army General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Nebulization will be offered in a one room and pulmonary function test will be performed in the other room. Both patients and the pulmonary function test technician will be masked to the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: February 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 5 years following publication
• Access Criteria: contacting the corresponding author

Locations

CN (1)