Clinical Study of the AffloVest

Transcription

1 Clinical Study of the AffloVest as a High Frequency Chest Wall Oscillation Device March 13 International Biophysics Corporation 11 E. St. Elmo Road, Building, Suite 75, Austin, Tx 787 (51) afflovest@ibcbio.com

2 Contents Descriptive Information Location of Study Supervising Clinical Director for Study Physiotherapists Involved with Treatment of Patients Contracting Entity for Study Contracted Study Supervisor for IBC Manufacturer Device Model Study Type Study Design Arms, Groups, and Cohorts Eligibility Ages Eligible for Clinical Study Sexes Eligible for Clinical Study Acceptance of Healthy Volunteers in the Clinical Study Inclusionary Criteria Exclusionary Criteria Purpose 3 Implementation 3 Expectations of Clinical Results 3 Graphical Data from Clinical Question on the Viscosity of Bronchial Secretions Before Introduction of AffloVest Question on Productivity of Cough Before Introduction of Afflovest Question on the Viscosity of Bronchial Secretions After Introduction of AffloVest Question on Productivity of Cough After Introduction of Afflovest Analysis of Graphical Data 5 Limitations 5 Conclusion 5 1

3 Descriptive Information Location of Study Bad Reichenhall Clinic Pneumological and Orthopedic Rehabilitation Salzburger Strasse 9-11, 8335 Bad Reichenhall Supervising Clinical Director for Study Dr. Konrad Schultz Physiotherapists Involved with Treatment of Patients Mr. Dumberger Mr. Schmied Contracting Entity for Study International Biophysics Corporation Contracted Study Supervisor for IBC Mr. Dirk Dittman Manufacturer International Biophysics Corporation Device Model The AffloVest by IBC Study Type This study is an interventional analysis of the effect the introduction of the AffloVest as a therapeutic aid has on the patient s ability to cough more productively. Study Design This study is a randomized efficacy study in the usage of the AffloVest as an HFCWO treatment device, gathering the patient pool from a larger selection of suitable candidates, as compiled on various eligibility concerns with the help of the Supervising Clinical Director of the respiratory clinic at Bad Reichenhall. Arms, Groups, and Cohorts The active comparator in this study is the pulmonary and orthopedic care patients were already receiving at the clinic through physiotherapist, prior to the introduction of the AffloVest. The experimental is the High Frequency Chest Wall Oscillation treatment added three times per day for 1 minutes in each session to the patient s usual airway clearance techniques found in the active comparator. Eligibility Ages Eligible for Clinical Study This clinical study accepted any patients over the age of 18 for inclusion in the selection pool. Sexes Eligible for Clinical Study There was no acceptance or exclusion from the patient pool of this clinical study on the basis of sex and both men and women were eligible. Acceptance of Healthy Volunteers in the Clinical Study There was no acceptance of healthy volunteers in this clinical study, as the entire patient selection pool was obtained from those already receiving pulmonary and orthopedic care at the respiratory clinic of Bad Reichenhall. Inclusionary Criteria The patient must be over the age of 18, already receiving pulmonary and orthopedic care at the respiratory clinic, and must be able to provide informed consent. Exclusionary Criteria The patient could not be suffering from a current severe haemoptysis, pregnant, currently have rib fractures or a history of rib fractures, have a lung abscess, require more than 3 assisted treatment sessions per day, or be unable to provide informed consent.

4 Purpose High Frequency Chest Wall Oscillation (HFCWO) is the rapid oscillation of the patient chest wall with the usage of pneumatic energy in order to promote a more productive cough in the patient. HFCWO has been demonstrated to effectively promote the mobilization of bronchopulomary secretions over a control group. This has led to the development of various HFCWO technologies over the last decade, the latest and most innovative of these being the uniquely portable AffloVest. The aim of this study is to measure and document what benefits AffloVest is providing patients already receiving pulmonary and orthopedic care at a respiratory clinic when introduced as an additional therapeutic aid. Implementation The AffloVest will be approved for use with a selection of patients in the clinic by the attending physician in charge, as well as the nature of the therapy explained and documented with the approved patient pool in order to obtain informed consent. The study will begin with the documenting of the patient pool s ability to expectorate mucus and perform a more productive cough through the completion of a questionnaire prior to the introduction of the AffloVest as a treatment aid. The AffloVest shall be worn up to three times per day for a duration of 1 minutes by each patient involved in the study. The intensity, program mode, and postural positioning of the patient during treatment shall be determined on an individual basis between the attending therapist and the patient. After the patients have received treatment with the AffloVest, a subsequent questionnaire will be completed that again asks the patients about their ability to expectorate mucus and perform a more productive cough with the introduction of the AffloVest as a treatment aid. The questionnaires will also ask the patient, with guidance from the Clinical Director and the attending physiotherapists, the nature of the viscosity of their mucosal secretions (on a scale of more fluid or more thick). Expectations of Clinical Results Without the therapeutic support offered by HFCWO technology through the Afflovest, it is expected that patients will primarily rate their abilities to expectorate mucus and cough productively as less than sufficient or below average. This is represented by a rating selection on the questionnaire scale between 3-5 (5 being the poorest expectoration performance and a very unproductive cough or inability to cough). With the introduction of the AffloVest, it is expected that these numerical ratings by the patients on the scale shall, on average, move more towards the - range (signifying an improvement in the ease of expectoration of mucus and an increase in the productivity of the patient s cough). 3

5 Graphical Data from Clinical The clinical study began with a patient selection pool of 33 individuals, of which were able to receive sufficient AffoVest HFCWO treatments and ultimately completed the secondary questionnaire. Question on the Viscosity of Bronchial Secretions Before Introduction of AffloVest Question on Productivity of Cough Before Introduction of Afflovest Viscosity Levels Productivity of Cough Viscosity Levels Productivity of Cough Question on the Viscosity of Bronchial Secretions After Introduction of AffloVest Question on Productivity of Cough After Introduction of Afflovest Viscosity Levels 3 3 Productivity of Cough Viscosity Levels Productivity of Cough

6 Analysis of Graphical Data Prior to the introduction of the AffloVest and with just the implementation of the patient s existing pulmonary and orthopedic regimen of care, 8.5% of patients had relatively fluid bronchial secretions (landing somewhere between - on the scale) and 51.5% of the patients had much thicker bronchial secretions (falling between 3-5 on the scale). Additionally, only.5% of patients were able to cough productively (again, scoring between -) while 57.5% had relatively less productive coughs or a near inability to cough at all (scaled between 3-5). These figures demonstrate that the active comparator treatment already being implemented at the clinic was somewhat effective in just a little under half of the patients receiving care. After the introduction of the AffloVest and the implementation of High Frequency Chest Wall Oscillation (HFCWO) to the care regimen of the patients, 75% of patients had relatively fluid bronchial secretions (landing somewhere between - on the scale) and only 5% of the patients had thicker bronchial secretions (falling between 3-5 on the scale). Similarly, 75% of patients found they were able to cough more productively (scaled -) and only 5% had less productive coughs. The statistics of those scoring in the 3-5 range can however be additionally examined to determine if there was still improvement in condition. Prior to the introduction of HFCWO to their regimens, a full 7% of patients who rated their secretions as thicker scored a or 5 on the scale (5 being the thickest). After the introduction of HFCWO, the percentage of patients in the 3-5 range that rated their secretions as either a or 5 dropped to just %. Similarly, 57% those scoring in the 3-5 range in cough productivity (5 being the most unproductive of coughs) prior to the introduction of the AffloVest and HFCWO therapy scored their coughs as a or 5. After the introduction of the AffloVest and HFCWO therapy, this percentage dropped to just 5% of patients, demonstrating improvement in cough productivity even in the most severe of cases. Limitations There are always limitations to conducting a clinical study of this nature. The first of these would be the small sample size of the experimental cohort. It is always preferable to have a larger arm with which to conduct clinical research. Secondly, there are still limited pre-existing clinical studies on High Frequency Chest Wall Oscillation technology, even though HFCWO has now been an accepted treatment option in respiratory care for more than a decade. Lastly, there s always some deficiency in case of self-reported data. This study attempted to mitigate this factor by including the counsel of the attending physicians to best assist the patients in examining their symptoms prior to and after receiving HFCWO treatment with the AffloVest. Conclusion With every single patient, a dramatic improvement in cough productivity and bronchial secretion viscosity was observed in combination with the pulmonary and orthopedic regimen of care. It became fundamentally easier for the patients to cough out mucus, because of the more fluid secretions and more productive cough provided by the introduction of High Frequency Chest Wall Oscillation treatment with the AffloVest. Additional examinations and clinical studies with an even greater sample size of patients could be beneficial in further confirming the therapeutic benefits of incorporating the AffloVest HFCWO device in regimens of respiratory care. 5