Limits...
Treatment of asthma exacerbations with the human-powered nebuliser: a randomised parallel-group clinical trial.

Hallberg CJ, Lysaught MT, Najarro RA, Cea Gil F, Villatoro C, Diaz de Uriarte AC, Olson LE - NPJ Prim Care Respir Med (2014)

Bottom Line: The study was not blinded as this was clinically unfeasible; however, data analysis was blinded.The mean improvement in peak flow of the experimental and control groups was 37.5 (95% confidence interval (CI) 26.7-48.2) l/min and 38.7 (95% CI, 26.1-51.3) l/min, respectively, with a mean difference of 1.3 (95% CI, -15.1 to 17.7) l/min.The mean improvement in percent-expected peak flow for the experimental and control groups was 12.3% (95% CI, 9.1-15.5%) and 13.8% (95% CI, 9.8-17.9%), respectively, with a mean difference of 1.5% (95% CI, -3.6 to 6.6%).

View Article: PubMed Central - PubMed

Affiliation: 1] Department of Biomedical Engineering, Marquette University, Milwaukee, WI, USA [2] School of Medicine, University of Washington, Seattle, WA, USA.

ABSTRACT

Background: Nebulisers aid the treatment of respiratory diseases, including asthma, but they require electricity and are often cost-prohibitive for low- and middle-income countries.

Aims: The aim of this study was to compare a low-cost, human-powered nebuliser compressor with an electric nebuliser compressor for the treatment of mild to moderate asthma exacerbations in adults and children.

Methods: This was a non-blinded, parallel-group, equivalence study, with 110 subjects between 6 and 65 years of age, conducted in the emergency department of a district hospital in Ilopango, El Salvador. Participants were assigned by random allocation to receive a 2.5-mg dose of salbutamol from the experimental human-powered nebuliser or the electric nebuliser control. All assigned participants completed treatment and were included in analysis. The study was not blinded as this was clinically unfeasible; however, data analysis was blinded.

Results: The mean improvement in peak flow of the experimental and control groups was 37.5 (95% confidence interval (CI) 26.7-48.2) l/min and 38.7 (95% CI, 26.1-51.3) l/min, respectively, with a mean difference of 1.3 (95% CI, -15.1 to 17.7) l/min. The mean improvement in percent-expected peak flow for the experimental and control groups was 12.3% (95% CI, 9.1-15.5%) and 13.8% (95% CI, 9.8-17.9%), respectively, with a mean difference of 1.5% (95% CI, -3.6 to 6.6%).

Conclusions: The human-powered nebuliser compressor is equivalent to a standard nebuliser compressor for the treatment of mild-to-moderate asthma. (Funded by the Opus Dean's Fund, Marquette University College of Engineering; ClinicalTrials.gov NCT01795742.).

Show MeSH

Related in: MedlinePlus

Randomisation and analysis.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4373316&req=5

fig2: Randomisation and analysis.

Mentions: This was a parallel-group trial, where each participant was randomly assigned to receive treatment with the experimental HPN compressor (Marquette University, Milwaukee, WI, USA) or the control EN compressor (DeVilbiss Pulmo-Aide 5650D, Somerset, PA, USA). Device assignment was determined by removal of a coloured tile from an opaque bag containing 55 tiles of one colour and 55 tiles of another, representing a total of 110 subjects (Figure 2). The study assistant selected the tiles and assigned each participant to the indicated group. Identical nebulisers and masks (Hudson RCI Micro Mist, Teleflex, Research Triangle Park, NC, USA) were used with both nebuliser compressors. This trial was not blinded to the participant and study care providers, as concealing the type of nebuliser compressor used was unfeasible in the clinical environment. Researchers performing data analysis were blinded to group assignment until after data analyses were performed. Each participant received a single salbutamol dose, 2.5 mg (0.5 ml of 0.5% salbutamol sulphate) in 2.5 ml of 0.9% saline in accordance with Global Initiative for Asthma and Salvadoran Ministry of Health guidelines. Both nebuliser compressors were run until completion, ~20 min. The HPN was operated by a study assistant, at a speed of ~60 revolutions per minute. The operation of the HPN does not require precise speed; an internal flow regulator ensures that the HPN produces either the prescribed airflow or none at all.


Treatment of asthma exacerbations with the human-powered nebuliser: a randomised parallel-group clinical trial.

Hallberg CJ, Lysaught MT, Najarro RA, Cea Gil F, Villatoro C, Diaz de Uriarte AC, Olson LE - NPJ Prim Care Respir Med (2014)

Randomisation and analysis.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4373316&req=5

fig2: Randomisation and analysis.
Mentions: This was a parallel-group trial, where each participant was randomly assigned to receive treatment with the experimental HPN compressor (Marquette University, Milwaukee, WI, USA) or the control EN compressor (DeVilbiss Pulmo-Aide 5650D, Somerset, PA, USA). Device assignment was determined by removal of a coloured tile from an opaque bag containing 55 tiles of one colour and 55 tiles of another, representing a total of 110 subjects (Figure 2). The study assistant selected the tiles and assigned each participant to the indicated group. Identical nebulisers and masks (Hudson RCI Micro Mist, Teleflex, Research Triangle Park, NC, USA) were used with both nebuliser compressors. This trial was not blinded to the participant and study care providers, as concealing the type of nebuliser compressor used was unfeasible in the clinical environment. Researchers performing data analysis were blinded to group assignment until after data analyses were performed. Each participant received a single salbutamol dose, 2.5 mg (0.5 ml of 0.5% salbutamol sulphate) in 2.5 ml of 0.9% saline in accordance with Global Initiative for Asthma and Salvadoran Ministry of Health guidelines. Both nebuliser compressors were run until completion, ~20 min. The HPN was operated by a study assistant, at a speed of ~60 revolutions per minute. The operation of the HPN does not require precise speed; an internal flow regulator ensures that the HPN produces either the prescribed airflow or none at all.

Bottom Line: The study was not blinded as this was clinically unfeasible; however, data analysis was blinded.The mean improvement in peak flow of the experimental and control groups was 37.5 (95% confidence interval (CI) 26.7-48.2) l/min and 38.7 (95% CI, 26.1-51.3) l/min, respectively, with a mean difference of 1.3 (95% CI, -15.1 to 17.7) l/min.The mean improvement in percent-expected peak flow for the experimental and control groups was 12.3% (95% CI, 9.1-15.5%) and 13.8% (95% CI, 9.8-17.9%), respectively, with a mean difference of 1.5% (95% CI, -3.6 to 6.6%).

View Article: PubMed Central - PubMed

Affiliation: 1] Department of Biomedical Engineering, Marquette University, Milwaukee, WI, USA [2] School of Medicine, University of Washington, Seattle, WA, USA.

ABSTRACT

Background: Nebulisers aid the treatment of respiratory diseases, including asthma, but they require electricity and are often cost-prohibitive for low- and middle-income countries.

Aims: The aim of this study was to compare a low-cost, human-powered nebuliser compressor with an electric nebuliser compressor for the treatment of mild to moderate asthma exacerbations in adults and children.

Methods: This was a non-blinded, parallel-group, equivalence study, with 110 subjects between 6 and 65 years of age, conducted in the emergency department of a district hospital in Ilopango, El Salvador. Participants were assigned by random allocation to receive a 2.5-mg dose of salbutamol from the experimental human-powered nebuliser or the electric nebuliser control. All assigned participants completed treatment and were included in analysis. The study was not blinded as this was clinically unfeasible; however, data analysis was blinded.

Results: The mean improvement in peak flow of the experimental and control groups was 37.5 (95% confidence interval (CI) 26.7-48.2) l/min and 38.7 (95% CI, 26.1-51.3) l/min, respectively, with a mean difference of 1.3 (95% CI, -15.1 to 17.7) l/min. The mean improvement in percent-expected peak flow for the experimental and control groups was 12.3% (95% CI, 9.1-15.5%) and 13.8% (95% CI, 9.8-17.9%), respectively, with a mean difference of 1.5% (95% CI, -3.6 to 6.6%).

Conclusions: The human-powered nebuliser compressor is equivalent to a standard nebuliser compressor for the treatment of mild-to-moderate asthma. (Funded by the Opus Dean's Fund, Marquette University College of Engineering; ClinicalTrials.gov NCT01795742.).

Show MeSH
Related in: MedlinePlus