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Study of the effectiveness of bronchial clearance in subjects with upper spinal cord injuries: examination of a rehabilitation programme involving mechanical insufflation and exsufflation
Pillastrini P, Bordini S, Bazzocchi G, Belloni G, Menarini M
Spinal Cord 2006 Oct;44(10):614-616
clinical trial
1/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

STUDY DESIGN: Randomized controlled trial. OBJECTIVES: To establish whether the use of mechanical insufflation/exsufflation leads to a significant improve in tracheostomy subjects with upper spinal cord injuries (C1-C7), ASIA classification grade A and bronchial hyper secretion the following parameters: forced vital capacity (FVC), forced exspiratory volume on the first second (FEV1), FEV1/FVC, peak exspiratory flow (PEF), arterious pressure of O2 (PaO2), arterious pressure of CO2 (PaCO2), pH, saturation of O2 (SaO2). SETTING: Spinal Cord Unit, Montecatone Rehabilitation Institute, Imola, Italy. METHODS: The patients were split into two groups: the experimental group (EG) and the control group (CG). Each patient was given 10 treatments: the EG was given manual respiratory kinesitherapy associated with mechanical insufflation/exsufflation with inhale and exhale pressure between 15 cmH2O and 45 cmH2O, while the CG was only given manual kinesitherapy. The treatment sessions covered the necessary amount of time in order to achieve sufficient clearance. The study has been approved by the local ethic committee. The patients were informed before being enrolled in that study and gave their written consent. RESULTS: At the end of the treatment associated with the mechanical insufflation/exsufflation, the EG showed a significant increase in FVC, FEV1 and PEF, although it was not possible to compare the latter with the CG. The other parameters were also subject to variations, although not statistically significant. The CG did not show signs of any significant change. CONCLUSION: The use of mechanical insufflation/exsufflation in subjects with the aforementioned characteristics is shown to be an effective adjunct to manual respiratory kinesitherapy, since it makes it possible to achieve adequate bronco-pulmonary clearance, even removing thick, deep secretions and making it possible to insufflate any areas affected by atelectasis.
Reprinted by permission from Spinal Cord, Macmillan Publishers Ltd.

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