Tiffany J Dwyer1, Lisel Robbins2, Patrick Kelly3, Amanda J Piper4, Scott C Bell5, Peter T P Bye1. 1. Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney. 2. Adult Cystic Fibrosis Centre, The Prince Charles Hospital. 3. Sydney School of Public Health, University of Sydney. 4. Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital; Woolcock Institute of Medical Research, Sydney. 5. Adult Cystic Fibrosis Centre, The Prince Charles Hospital; QIMR Berghofer Medical Research Institute, Brisbane, Australia.
Abstract
QUESTION: During an acute exacerbation of cystic fibrosis, is non-invasive ventilation beneficial as an adjunct to the airway clearance regimen? DESIGN: Randomised controlled trial with concealed allocation and intention-to-treat analysis. PARTICIPANTS: Forty adults with moderate to severe cystic fibrosis lung disease and who were admitted to hospital for an acute exacerbation. INTERVENTION: Comprehensive inpatient care (control group) compared to the same care with the addition of non-invasive ventilation during airway clearance treatments from Day 2 of admission until discharge (experimental group). OUTCOME MEASURES: Lung function and subjective symptom severity were measured daily. Fatigue was measured at admission and discharge on the Schwartz Fatigue Scale from 7 (no fatigue) to 63 (worst fatigue) points. Quality of life and exercise capacity were also measured at admission and discharge. Length of admission and time to next hospital admission were recorded. RESULTS: Analysed as the primary outcome, the experimental group had a greater rate of improvement in forced expiratory volume in 1 second (FEV1) than the control group, but this was not statistically significant (MD 0.13% predicted per day, 95% CI -0.03 to 0.28). However, the experimental group had a significantly higher FEV1 at discharge than the control group (MD 4.2% predicted, 95% CI 0.1 to 8.3). The experimental group reported significantly lower levels of fatigue on the Schwartz fatigue scale at discharge than the control group (MD 6 points, 95% CI 1 to 11). There was no significant difference between the experimental and control groups in subjective symptom severity, quality of life, exercise capacity, length of hospital admission or time to next hospital admission. CONCLUSION: Among people hospitalised for an acute exacerbation of cystic fibrosis, the use of non-invasive ventilation as an adjunct to the airway clearance regimen significantly improves FEV1 and fatigue. TRIAL REGISTRATION: ANZCTR 12605000437662.
RCT Entities:
QUESTION: During an acute exacerbation of cystic fibrosis, is non-invasive ventilation beneficial as an adjunct to the airway clearance regimen? DESIGN: Randomised controlled trial with concealed allocation and intention-to-treat analysis. PARTICIPANTS: Forty adults with moderate to severe cystic fibrosis lung disease and who were admitted to hospital for an acute exacerbation. INTERVENTION: Comprehensive inpatient care (control group) compared to the same care with the addition of non-invasive ventilation during airway clearance treatments from Day 2 of admission until discharge (experimental group). OUTCOME MEASURES: Lung function and subjective symptom severity were measured daily. Fatigue was measured at admission and discharge on the Schwartz Fatigue Scale from 7 (no fatigue) to 63 (worst fatigue) points. Quality of life and exercise capacity were also measured at admission and discharge. Length of admission and time to next hospital admission were recorded. RESULTS: Analysed as the primary outcome, the experimental group had a greater rate of improvement in forced expiratory volume in 1 second (FEV1) than the control group, but this was not statistically significant (MD 0.13% predicted per day, 95% CI -0.03 to 0.28). However, the experimental group had a significantly higher FEV1 at discharge than the control group (MD 4.2% predicted, 95% CI 0.1 to 8.3). The experimental group reported significantly lower levels of fatigue on the Schwartz fatigue scale at discharge than the control group (MD 6 points, 95% CI 1 to 11). There was no significant difference between the experimental and control groups in subjective symptom severity, quality of life, exercise capacity, length of hospital admission or time to next hospital admission. CONCLUSION: Among people hospitalised for an acute exacerbation of cystic fibrosis, the use of non-invasive ventilation as an adjunct to the airway clearance regimen significantly improves FEV1 and fatigue. TRIAL REGISTRATION: ANZCTR 12605000437662.
Authors: Sonya L Heltshe; Natalie E West; Donald R VanDevanter; D B Sanders; Valeria V Beckett; Patrick A Flume; Christopher H Goss Journal: Contemp Clin Trials Date: 2017-11-21 Impact factor: 2.226
Authors: Patricia Rocamora-Pérez; María Jesús Benzo-Iglesias; María de Los Ángeles Valverde-Martínez; Amelia Victoria García-Luengo; José Manuel Aguilar-Parra; Rubén Trigueros; Remedios López-Liria Journal: Ther Adv Respir Dis Date: 2022 Jan-Dec Impact factor: 5.158