RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DESERTATION

1. Name of the candidate & Divya Rajan,

# 20&21, 2nd B, B-block,
address
8th A cross, Mathikere,
Bangalore – 54.

2. Name of the Institution Kempegowda Institute of Physiotherapy,

Bangalore.

3. Course of the study and M.P.T. (Cardio-Respiratory Disorders &

subject Intensive care)

4. Date of admission to the 9th June 2008

course

5. Title of the Topic

“A comparative study between the effectiveness of incentive spirometry and deep

breathing exercises in improving pulmonary function following cardiac valve
replacement surgery.”

1
6 Brief resume of the Intended work

6.1 Need for the study:

The heart is a muscle that pumps blood into arteries throughout the body. The
human heart has four chambers and four heart valves which regulates blood flow
through the heart.
The valves present in the heart are :

 The Tricuspid valve regulates blood flow between the right atrium and right
ventricle.
 The Pulmonary valve controls blood flow from the right ventricle into the
pulmonary arteries, which carry blood to the lungs.
 The Mitral valve lets the oxygenated blood from the lungs to pass from the
left atrium into the left ventricles.
 The Aortic valve opens the way for oxygenated blood to pass from the left
ventricle into the Aorta. It is the body’s largest artery and delivers blood to
all parts of the body.
The incidence of valvular diseases varies considerably in different part of the
world. It is very common and presents at an earlier age. It is very prevalent in the
Middle East, the Indian subcontinent and the Far East.

Valvular heart disease occurs due to abnormality of one or more heart valves. The
heart valves can get damaged due to infection, rheumatic fever, ageing process, or it
may be a birth defects. Valvular disease can involve a valve that does not close
properly (insufficiency) or due to narrowing (stenosis). The end result of any defective
heart valve is decrease in the pumping activity of blood. The over worked heart may
fail causing symptoms such as dizziness, chest pain, shortness of breath, fatigue and
fluid retention. As these symptoms worsen, a decision need to be made on whether the
heart valve needs to be repaired or replaced.

The diseased heart valves can be replaced with mechanical or biological prostheses.
The three most commonly used mechanical prostheses are the ball, cage, tilting single
disc and tilting by leaflet valve1.

Clinical manifestations of post operative pulmonary dysfunction (PPD) range from

arterial hypoxemia in 100% of patients to acute respiratory distress syndrome, which
occurs in 0.4% to 2.0% of patients. An alterations in the mechanical properties of the
lung leads to reduction in vital capacity, residual capacity and static and dynamic lung
compliance.

Post operative pulmonary dysfunction refers to expected alterations in

pulmonary functions such as increased work of breathing, shallow respiration,
ineffective cough and hypoxemia2.

Changes in pulmonary functions and/or pulmonary complications may occur

following upper abdominal and thoracic surgeries. In the early post operative period,
that patient may not achieve sufficient inspiration; ciliary activity and coughing reflex

2
 decrease and mucus accumulation in the lung increase as a result the complication risk
increases3.

The lung function will be measured by pulmonary function test (PFT) which is
widely used to determine the existence of post operative pulmonary complications.
Studies have shown that pulmonary function test values decrease in the early post
operative period following any cardio thoracic surgeries. The incidence of pulmonary
complication ranges between 30% to 50%. The complication ratio of the pulmonary
function is related closely to factors such as type and site of incision, duration of the
surgery, mechanical changes in the thorax which occur during the surgery,
parenchymal deterioration of the lungs, the effect of anesthesia and insufficient post
operative cardio pulmonary physiotherapy3.

Incentive siprometry is a device which is used for improving the pulmonary

function. It is a device which provides patients with visual feed back when they
inhale at a pre-determined flow rate /volume and sustain the inflation for a minimum
three seconds and then expire. Incentive spirometry also refers to as sustained
maximum inspiration (SMI)4. Incentive spirometry improves lung volume, increases
thoracic movement and increases ventilation.

Deep breathing exercises. These exercises are aimed at increasing lung volume,
redistribution of ventilation, improving gas exchange, increasing thoracic movement
and mobilization of secretion5.

In my study I would like to compare the effectiveness of incentive Spirometry and

deep breathing exercises in improving the pulmonary Dysfunction after cardiac valve
replacement surgery.

Hypothesis-

Null Hypothesis –
It may be seen that deep breathing exercises and incentive Spirometry is not
effective in improving pulmonary function following cardiac valve replacement
surgery.

Alternate Hypothesis -
It may be seen that incentive spirometry is effective in improving pulmonary
function following cardiac valve replacement surgery.

6.2 LITERATURE REVIEW:

 Rochelle Wynne et al. (2004) studied post operative pulmonary dysfunction
in adults after cardiac surgery and concluded the effectiveness of pulmonary
interventions applied for a longer time would be beneficial in the
management of post operative pulmonary dysfunction1.

 N M Siafakas et al (1999) studied surgery and respiratory muscle dysfunction 7.

 Charles Weissman et al. (1999) studied and found change in the pulmonary

3
 function after cardiac and thoracic surgery the structure and function of the
respiratory system.

 Grant AF et al. (1962) studied recent advances in thoracic surgery in preventing

postoperative pulmonary complication.

 Barna Babik et al. (2003) studied changes in respiratory mechanics during cardiac
surgery and demonstrated that significant changes occur in the mechanical
properties of the respiratory system during cardiac surgery 6.

 Valerie A.Larwrence et al. (2006) systematically reviewed the literature on

interventions to prevent post operative pulmonary complications after non cardiac
surgery and found good evidence on lung expansion therapy that reduces post
operative pulmonary complications 8.

 Hulya Akdur et al. (2001) study was to compare pre and post operative pulmonary
function test in adult patients who had intubation periods greater and less than 24
hours following elective open heart surgery. They agree that intensive and effective
PT programs which are applied post operatively improve pulmonary functions,
decrease the incidence of pulmonary complications and shorten the hospitalization
period 3.

 Jean N Crowe, Christine A Vradley et al. (1997) studied to determine whether the
addition of incentives spirometry to post operative pulmonary physiotherapy is
more effective than physical therapy alone in reducing post operative pulmonary
complication in high risk patients after CABG and concluded there may be an
added benefit by the addition of incentives spirometry to post operative pulmonary
physiotherapy11.

 P Agostini et al. (2007) studied whether incentives spirometry is a useful

intervention for patients after thoracic surgery and found incentive spiromerty is
good measure of lung function and avoid post operative complications 12.

 Jackle A Thomas et al. (1994) studied Are incentive siprometry, IPPB and deep
breathing exercises effective in the prevention of post operative pulmonary
complication after upper abdominal surgery and concluded incentives spirometry
and deep breathing exercises to be more effective in preventing post operative
pulmonary complications.

 Jose A Melendez et al. (1992) studied respiratory muscles mechanics during

incentive spirometry and found the mechanism underlying the possibly beneficial
effect is poorly understood.

 G.D Gale and D.E Sanders et al. (1980) studied treatment with IPPB and

4
 incentives spirometry was compared after heart surgery and cardio pulmonary by
pass and found possibly IS treatment given more frequently may be more
effective15.

 J.P fenninger and F.Roth et al. (1977) compared IPPB and incentive spirometer in
post operative period and concluded incentive spirometer may be superior to IPPB
as the patient is left to continue their own respiratory therapy.

 Josef Weindler et al. (2001) studied the efficacy of post operative incentives
siprometer is influenced by the device specific imposed work of breathing and
concluded incentive spirometer with low W B imp permit increased maximal
sustained inspiration and thus enhanced incentive spirometer performance and
therefore it might more suitable for use in post operative respiratory care 14.

 Elisabeth Westerdahl et al. (2005) investigated the effect of deep breathing

exercises on pulmonary function and concluded significant better pulmonary
function16.

 John C Hall et al. (1996) studied the prevention of respiratory complication after
abdominal surgery and concluded the most efficient regimen of prophylaxis
against respiratory complication after abdominal surgery is deep breathing
exercises for low risk patients and incentive spirometry for high risk patients.

6.3 Objective of study:

1) To study the effectiveness of incentive spirometry in improving pulmonary

function following cardiac valve replacement.

2) To study the effectiveness of deep breathing exercises in improving pulmonary

function following cardiac valve replacement .

Material and Methods:

7.1 Study design: Comparative evaluation study

7.2 Source of Data:

 Sri Jayadeva institute of cardiology.

 Kempegowda institute of medical sciences, Hospital and research center.

7.3 Method of collection of Data:

Sample size – 60 (GroupA-30, GroupB-30)

5
 a) Materials used-
 PFT(Spirometer)
 Incentive Spirometer
 Pillows
 Bed

b) Inclusion Criteria-

 Subjects who have undergone cardiac valve replacement surgery.

 Subjects who are extubated and are on their second day of surgery are included
in study.
 Subjects between age group of 45 – 60 years of age.
 Subjects include both sexes.
7
b) Exclusion criteria-

 Patients on ventilator longer than 72 hrs.

 Nausea and vomiting.
 Bleeding from the site of incision.
 Hemodynamic complications.

 Intra operative myocardial infarction.

 Major blood loss.
 Marked Hypertension.
 Reduced cardiac output requiring the use of an intra-aortic balloon
pump or extraordinary use of medications.
 Post operative infections.
 History of smoking.
 History of any respiratory disorder.

7.4 Does study needs any investigation or intervention to be conducted on patients or

other humans or animals? If so, please describe briefly:

Yes, an intervention on human subject’s area required.

Methodology:

 Consent of all patients will be taken.

 The subjects who are fulfilling inclusion and exclusion criteria will be included
in the study.

6
  Subjects will be instructed on how to perform the interventions.
 Subjects are put in two groups. (group A – 30, group B – 30)
 Subjects will be treated daily after extubation from the second post
operative day.
 Subjects in group A will be asked to perform incentive siprometry 10
breaths once per hour for 10 hrs when awake.
 Subjects in group B will be asked to perform 10 deep breaths once per
hour for 10 hrs when awake.

Pretest scoring-
 Pulmonary function test (PFT)
o Forced vital capacity (FVC)
o Forced expiratory volume in one second (FEV1)
o FEV1/FVC

Posttest scoring-
 Pulmonary function test (PFT)
o Forced vital capacity (FVC)
o Forced expiratory volume in one second (FEV1)
o FEV1/FVC

Duration of study – 1 year

Statistical Analysis-
 Student t-test
 Effect size
 Repeat measure ANOVA

7.5 Has ethical Clearance been obtained from your institution in case of 7.3?

Yes.

References:

1) Christopher Haslett, Edwin R Chilvers, Nicholas A Boon, Nicki R Colledge,

John A A hunter. Davidson’s Principles and practice of medicine. 19th ed.
Edinburgh: 1952. Pg467. Churchhill living stone.
2) Rochelle Wynne, Mari Botti. Post operative pulmonary dysfunction in adults
after cardiac surgery with cardio pulmonary bypass: Clinical significance and
implications for practice. Am J Crist Care 2004 Sep; 13 (5) : 384-93.
3) Hulya Akdur, Mine Gulden Polat, Zerrin Yigit, Umit Arabact, Semiramis
Ozyilmaz, Hulya Nilgun Gureses. Effects of long intubation period on
respiratory functions following open heart surgery. Jpn Heart J 2002 Sep; 43:

7
 523-30.
4) Clinical practice guide line incentive spirometry. Rc Journal 1991 Dec; 36(12):
1402-05.
5) Johannes P Van De Leur, Linda Denehy. Post operative mucus clearance. 2004.
Pg19. Lung biology in health and disease; 188.
6) Barna Babik, Tibor Asztalos, Ferenc Petak, Zoltan I Deak, Zoltan Hantos.
Changes in respiratory mechanics during cardiac surgery. Anesth Analg
2003;96:1280-87.
7) N M Siafakas, I Mitrouska, D Bouros, D Georgopoulos. Surgery and the
respiratory muscle. Thorax 1999;54:458-65.
8) Valerie A Lawrence, John E, Cornell, Gerald W, Smetana. Strategies to reduce
postoperative pulmonary complications after noncardiothoracic surgery: systemic
review for the American college of physician.American college of physicians 2006 Apr
18; 144(8):596-08.
9) JA Rouckema, EJ Carol, JB Prins. The prevention of pulmonary complications
after abdominal surgery in patients with noncompromised pulmonary status.
Arch Surg 1988 Jan;123(1).
10) Patrick Pasquina, Martin R Tramer, Bernhard Walder. Prophylactic respiratory
physiotherapy after cardiac surgery: Systemic review. BMJ 2003 Dec 13;327.
11) Jean M Crowe, Christine A Bradley. The effectiveness of incentive spirometry
with physical therapy for high-risk patients after CABG. Phys Ther 1997
Mar;77(3):260-68.
12) Paula Agostini, Rachel Calvert, Hariharan Subramanian, Babu N aidu. Is
incentive spirometry effective following thoracic surgery. Interact Cardiovasc
Thorac Surg 2007 nov 24.
13) Krastins I, Corey ML, Mcleod A, Edmonds J, Levison H, Moes F. An
evaluation of incentive spirometry in the management of pulmonary
complications after cardic surgery in a pediatric population. Crit Care Med 1982
Aug; 10(8):525-8.
14) Josef Weindler, Ralph Thomas Kiefer. The efficacy of post operative incentive
spirometry is influenced by the device-specific imposed work of breathing.
Chest 2001; 119: 1858-64.
15) G D Gale, DE Sanders. Incentive spirometry : its value after cardiac surgery.
Canda Anaesth Soc J. 1980 Sep; 27(5): 475-80.
16) Elisabeth Westerdahl, Birgitta Lindmark, Tomas Erikeson, Orjan Friberg, Goran
Hedenstierna, Arne Tenling. Deep breathing exercises reduce atelectasis and
improve pulmonary function after CABG surgery. Chest 2005 May 5; 128:
3482-3488.
17) E Westerdahl. Effects of deep breathing exercises after CABG. ACTA 2004.
18) ST. Joseph Health System Surgery Booklet [online]. Available from:
URL:http://www.sjo.org/HeartCenterSub.aspx?pageId=416
19) Clinical Pathway: Booklet Esophageal Surgery (Ottawa Hospital). [Online]. 2002

8
8 July. Available from: URL:http://www. ottawahospital.on.ca

9. Signature of the Candidate: :

Divya Rajan

10. Remarks of the Guide: The study is done to find the comparison between
the effectiveness of incentive spirometry and deep breathing exercises in
improving pulmonary function following cardiac valve replacement surgery

11. Names and designation of:

Prof. R. Balasaravanan, M.P.T

11.1 Guide: Principal, K.I.P.T

11.2 Signature:

Dr. Rachana Shetty B.V

11.3 Co-guide :
Lecturer, K.I.P.T

9
11.4 Signature:

11.7 Head of the Department: Prof. R. Balasaravanan, M.P.T

Principal,
K.I.P.T

11.8 Signature:

12.
12.1 Remarks of the Chairman & Principal:

12.2 Signature

10