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Rajiv Gandhi University of Health Sciences Bangalore ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. Name of the candidate and Address SRIJANI BANERJEE GARDEN CITY COLLEGE OF PHYSIOTHERAPY, 16th KM, OLD MADRAS ROAD, VIRGONAGAR POST, BANGALORE-49 2. Name of the Institution GARDEN CITY COLLEGE OF PHYSIOTHERAPY 3. Course of study and subject MASTER OF PHYSIOTHERAPY (PT in Cardio-Respiratory and ICU ) 4. Date of admission to course 07-09-2009 5. TITLE OF THE TOPIC: A STUDY ON THE EFFECT OF MANUAL LUNG HYPERINFLATION ON OXYGENATION AND HAEMODYNAMICS IN MECHANICALLY VENTILATED PATIENTS AFTER VALVE REPLACEMENT SURGERY. 6. BRIEF RESUME OF THE INTENDED WORK: 6.1 NEED FOR THE STUDY Ventilator support has become an integral part of post-surgical phase especially after cardiac surgeries like valve replacement, CABG, etc. At the same time it has also paved way for some other major dysfunctions of the respiratory and circulatory systems of the human body. Lack of lung inflation due to postoperative pain resulting in shallow and monotonous breathing pattern with the absence of periodic sighs and temporary diaphragmatic dysfunction are the some of the common complications seen in a patient after valve replacement. Also the mucociliary clearance is impaired postoperatively which decreases the cough effectiveness.1 Post surgical patients on mechanical ventilators are high risk cases as they also tend to have sputum retention and pulmonary complications like pneumonitis, atelectasis, surgical emphysema, etc.2 This in turn affects their oxygen saturation irrespective of their pre surgical lifestyle. These complications can be avoided and prevented with early and proper chest physiotherapy intervention. Manual lung hyperinflation (MHI) is one of the physiotherapy techniques which are employed in critical care setting. Usually MHI is used as amelioration to other physiotherapy techniques or only when other techniques of secretion clearance like postural drainage, percussion and vibration are not sufficient or effective. However, the efficacy of MHI when given in isolation is not clearly established. The effect of MHI with respect to clearance of excess and thick secretion and lung compliance have been well established,3 but there is limited evidence of the effect of MHI on oxygen saturation and hemodynamics in post-valve replacement surgery patients who are on mechanical ventilation. This study attempts to define the efficacy of MHI as an isolated physiotherapy maneuver and its effect on the oxygen saturation and hemodynamics of valve replacement surgery patients on mechanical ventilator support. The outcome of this study could yield greater understanding in the relevant importance of MHI in ICUs and may prove to be useful in treating patients which might improve the gaseous exchange and reduce the ill-effects of mechanical ventilators. 6.2 REVIEW OF LITERATURE 1. Blattner C et al [2008], did a study on effect of early manual lung hyperinflation on oxygenation and static compliance after a myocardial revascularization. They concluded that the group which received early MHI had markedly better oxygenation and shorter mechanical ventilation time.4 2. Pinheiro et al [2007], found out the correlation between respiratory modulation by chest physiotherapy and cardiovascular control. They found that respiratory physiotherapy reduces diastolic and systolic blood pressure and mean arterial pressure hence concluding it to be useful for cardiorespiratory control.5 3. Choi J S et al [2005], in their study on effect of manual hyperinflation and suctioning in respiratory mechanics in mechanically ventilated patients with ventilator associated pneumonia found that at high level of PEEP the central venous pressure and pulmonary capillary wedge pressure increased significantly and it induces beneficial changes in lung compliance and inspiratory resistance.5 4. Susan Berney [2002], did a study to compare the effects of manual and ventilator hyperinflation on static lung compliance and sputum production in intubated and ventilated intensive care patients and concluded that both methods of hyperinflation improve static lung compliance and clear pulmonary secretions.3 5. Jellema W T et al [2000], in their study on haemodynamic effects of intermittent manual lung hyperinflation(MHI) in patients with septic shock concluded that the haemodynamic effects with MHI are small and insignificant but is not contraindicated or risky in patients who are mechanically ventilated.6 6. Kathy Stiller [2000], did a study on the various chest physiotherapy maneuvers and proposed three phases of MHI which was maximally efficient in removal of secretion.7 7. L Denehy [1999], did a study on the use of manual hyperinflation in airway clearance and found that rapid expiratory phase enhances clearance of bronchial secretions. He also proposed giving 3-4 hyperinflations followed by tidal volume breaths.8 8. Shane Patman et al [1998], found that the use of manual hyperinflation in postoperated mechanically ventilated CABG patients, produce changes in mean pulmonary arterial pressure and central venous pressure but not of significant magnitude.9 9. Patti Klein et al [1988],in their study indicated rate pressure product is frequently elevated during chest physical therapy. It is important in management of patients who are undergoing surgery because it gives an indication of oxygen supply demanded by heart as well as the onset of ischemia.10 6.3 OBJECTIVE OF THE STUDY: 1. To determine the effect of MHI on SpO2 and Respiratory rate, heart rate, B.P, Mean arterial pressure and rate pressure product in mechanically ventilated patients after valve replacement surgery. 2. To compare between the pre- and post treatment values of the above mentioned parameters. 6.4 HYPOTHESIS: Null hypothesis: There is no significant difference between the pre- and post treatment oxygenation and hemodynamic parameters of mechanically ventilated patients after valve replacement surgery. Alternate Hypothesis: There is significant difference between the pre- and posttreatment oxygenation and hemodynamic parameters of mechanically ventilated patients after valve replacement surgery. 7. MATERIALS AND METHODS 7.1 SOURCES OF DATA: Data for study will be obtained from Cardiac ICUs in superspeciality hospitals. 7.2 METHOD OF COLLECTION OF DATA: Patients who are under mechanical ventilator support after valve replacement surgery are selected and assigned in a single group for pre and post treatment studies. STUDY DESIGN: Experimental Study Design SAMPLE SIZE; 30 patients. SAMPLING TECHNIQUE: Convenient Sampling technique(Non-Probability). DURATION: The duration of the study will be 6 months period. INCLUSION CRITERIA 1. Patients who have undergone valve replacement surgery (mitral valve, tricuspid valve, double valve replacement surgery) 2. Such patients on mechanical ventilation. EXCLUSION CRITERIA11 1. 2. 3. 4. 5. 6. 7. 8. Patients with unstable B.P. Patients with arrhythmias. Haemoptysis. High risk/ critically ill patients. Undrained pneumothorax. Patients with neurological disorders. Patients with traumatic injuries. Patients with Chest deformity. 7.3 ASSESSMENT TO BE DONE METHODOLOGY: 30 subjects after valve-replacement surgery in post operative day 1 and also on mechanical ventilation with stable hemodynamic parameters are selected. The treatment procedure will be explained to the selected patients. The vital signs of these patients are checked first. The bagging circuit is then connected to the oxygen supply and the flow rate is set at 15L/min. The patient is removed from the ventilator circuit carefully.7 The oxygen saturation and hemodynamic parameters for the selected subjects are recorded before giving any physiotherapy. The patient is now connected to the bagging circuit. Few normal tidal breaths are given to the patient to understand the compliance of the patient’s lungs. Then the subjects are given 3-4 hyperinflation followed by tidal volume breaths.8 The MHI technique has three phases. A slow inspiration is given followed by inspiratory hold phase of 1 to 2 secs. The bag is then rapidly released for forceful expiration.7 This is continued till secretions are heard or for 6-8 sets and after that suctioning is done.8 Immediately after the treatment is done the second set of readings are taken. The patient is then reconnected to the ventilator circuit and monitored for any change in status. Throughout the treatment session, the heart rate and blood pressure are monitored. The oxygenation i.e. SpO2 is measured using finger probe. For the hemodynamic parameters, the heart rate, blood pressure and respiratory rate are noted from the monitor. The mean arterial pressure and rate pressure product are calculated from the above values. STATISTICAL TOOL: The data will be analyzed by using Paired t-test. 7.4. ETHICAL CLEARENCE: Ethical clearance for the study has been obtained from the ethical committee of our institution 8. REFERENCES 1. Tom J Overend, Catherine M Anderson, S Deborah Lucy, Christina Bhatia, Birgitta Jonsson, Catherine Timmermans: The effect of incentive spirometry on postoperative pulmonary complications, Chest Sep 2001;vol 120,no.3,page 971-978. 2. Franz Konrad, Torstan Schreiber, Brecht-Kraus: Mucociliary transport in ICU patients, Chest Jan 1994,105;vol 1,page 237-241. 3. Susan Berney, Linda Denehy: A comparison of effects of manual and ventilator hyperinflation on static lung compliance and sputum production in intubated and ventilated intensive care patients, Physiotherapy Research International 2002,7(2): 100-108. 4. C Blattner, JC Guaranga, E Saadi: Oxygenation and static lung compliance is improved immediately after early lung manual hyperinflation following myocardial revascularization: a randomized control trial, Aust J Physiotherapy. 2008;54(3): 173-8 5. Pinheiro CH, Medeiros RA, Pinheiro DG, Marinho Mde J: Spontaneous respiratory modulation improves cardiovascular control in essential hypertension, Arq Bras Cardiol, 2007 Jun; 88(6); 651-9. 6. Choi JS, Jones AY: Effects of manual hyperinflation and suctioning in respiratory mechanics in mechanically ventilated patients with ventilator associated pneumonia, Australian journal of physiotherapy.2005, 51(1): 25-30. 7. Jellema WT, Groeneveld AB, van Goudoever J, Wesseling KH, Westerhof N, Lubbers MJ, Kesecioglu J, Van Lieshout JJ: Hemodynamic effects of intermittent manual lung hyperinflation in patients with septic shock, Heart Lung Sep-Oct 2000; 29(5) :356-366. 8. Kathy Stiller: Physiotherapy in intensive care- towards an evidence based practice, Chest Dec 2000; vol 118, no.6, 1801-1813. 9. L Denehy: Use of manual hyperinflation in airway clearance, European respiratory journal 1999; 14, 958-965. 10. Shane Patman, Sue Jenkins, Sue Bostock, Stephen Edlin: Cardiovascular responses to manual lung hyperinflation in post-operative coronary artery surgery patients, Physiotherapy theory and practice March 1998, vol 14, page 5-12. 11. Patti Klein, Marcia Kemper, Charles Weissman, Stanley H Rosenbaum, Jeffrey Askanazi and Allen I HPatti Klein, Marcia Kemper, Charles Weissman, Stanley H Rosenbaum, Jeffrey Askanazi and Allen I Hyman: Attenuation of haemodynamic responses to chest physical therapy, Chest 1988; 93; 38-42. 12. King D, Morell A: A survery on manual hyperinflation as a physiotherapy technique in ICU, Physiotherapy 1992; vol 78, page 788-795. 9. SIGNATURE OF THE CANDIDATE 10. REMARKS OF THE GUIDE 11. Name and designation of 11.1 GUIDE 11.2 SIGNATURE 11.3 CO-GUIDE 11.4 SIGNATURE 11.5 HEAD OF THE DEPARTMENT 11.6 SIGNATURE 12. 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL 12.2 SIGNATURE