RESEARCH PROPOSAL

THE EFFECT OF EARLY MOBILIZATION VERSUS ROUTINE PHYSIOTHERAPY

IN PREVENTION OF POST OPERATIVE PULMONARY COMPLICATIONS

FOLLOWING UPPER ABDOMINAL SURGERY- A COMPARITIVE STUDY.

MPT (CARDIO RESPIRATORY INCLUDING INTENSIVE CARE)

MR.ARIJIT KUMAR DAS

DEPARTMENT OF PHYSIOTHERAPY

FR. MULLER MEDICAL COLLEGE

MANGALORE-575002

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Rajiv Gandhi University of Health Science, Karnataka,

Bangalore

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the Candidate

and

Address

(in block letter)

ARIJIT KUMAR DAS

DEPT. OF PHYSIOTHERAPY

FATHER MULLER MEDICAL COLLEGE

KANKANADY,

MANGALORE-575002

2. Name of the Institution FATHER MULLER MEDICAL COLLEGE

3. Course of the study and subject MASTER OF PHYSIOTHERAPY

(CARDIO RESPIRATORY INCLUDING

INTENSIVE CARE)

4. Date of admission to Course 31-05-2008

5. Title of the Topic

THE EFFECT OF EARLY MOBILIZATION VERSUS ROUTINE

PHYSIOTHERAPY IN PREVENTION OF POST OPERATIVE PULMONARY

COMPLICATIONS FOLLOWING UPPER ABDOMINAL SURGERY - A

COMPARITIVE STUDY.

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6. BRIEF RESUME OF THE INTENDED WORK

6.1 Need of the study

The incidence of postoperative pulmonary complications after upper abdominal

surgery reported in the literature varies from 5% to 30% 1. In upper abdomen surgery,

patients develop a restricted pattern of breathing postoperatively with a decrease in vital

capacity (VC) and functional residual capacity (FRC). This decrease in lung volume is

associated with hypoxemia, broncho-pulmonary infection, pneumonia, airway

obstruction and hypercapnea and eventually progresses to postoperative respiratory

failure 2, 3. Decreased mucociliary clearance, diaphragm dysfunction, shallow and

monotonous breathing also develop postoperatively in upper abdominal surgery patients

and cause pulmonary complications 4.

Post operative pulmonary complication is the leading cause of postoperative

morbidity and mortality, increased hospital length of stay and hence cost 5. Postoperative

pain intensity also is more among the elderly abdominal surgery patients who develop

postoperative pulmonary complications 6.

Chest physiotherapy is frequently used in the prevention and treatment of

postoperative pulmonary complications after major abdominal surgery7. Chest

physiotherapy techniques include deep breathing exercises and splinted coughing.

Early mobilization also is an important treatment component of postoperative care

following upper abdominal surgery. There is no standard definition for early mobilization

and it has been reported to include: moving in bed, sitting out of bed, standing, and

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ambulation on the spot, hallway ambulation, low intensity exercises8. Low intensities of

mobilization can have a direct and profound effect on oxygen transport in patients with

acute cardiopulmonary dysfunction 9.

Few studies have been performed to evaluate the efficacy of the different

physiotherapy techniques and early mobilization. Hence it is important to compare the

effect of both the techniques in the reduction of pulmonary complications following

upper abdominal surgery.

Operational Definition

Routine physiotherapy includes deep breathing exercises, splinted coughing and

mobilization from 3rd post operative day.

Research Question

Is there any reduction in the incidence of clinically significant, postoperative

pulmonary complications in high risk upper abdominal surgery patient due to early

mobilization in comparison to routine physiotherapy?

Hypothesis

There will be a significant reduction in the incidence of postoperative pulmonary

complications in upper abdominal surgery patients due to early mobilization.

Null hypothesis

There will be no significant reduction in the incidence of postoperative pulmonary

complications in upper abdominal surgery patients due to early mobilization.

6.2 Review of Literature

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Watson2 conducted a study in post operative pulmonary complications associated with

anesthesia and concluded that post operative pulmonary complications are a significant

concern for anesthesia caregivers because they use drugs and techniques that temporarily

decrease lung volume, impair airway reflexes, limit immune function, and depress

secretion mobilization. To prevention or limit post operative pulmonary complications

they developed a perioperative pulmonary risk management strategy and concluded that

the patient should be ambulated as soon as possible.

Stiller and Munday7 said in their study of “Chest physiotherapy for the surgical

patient”, that chest physiotherapy is effective in the prevention and treatment of

pulmonary complication after major abdominal and thoracic surgery.

Browning, Denehy, Rebecca, Scholes8 conducted an observation study on early upright

mobilization performed following upper abdominal surgery. Fifty patients who had

undergone upper abdominal surgery after receiving standardized preoperative education

and physiotherapy intervention on the first postoperative day. They used postoperative

factors such as postoperative pulmonary complication, surgical attachments, pain relief,

duration of anesthesia, intensive care admission in first four postoperative days as

outcome measures. The results showed that the quantity of upright mobilization

performed was low and increased, early, upright mobilization might have a positive

effect on reducing length of stay following upper abdominal surgery.

Mackay and her colleagues10 conducted a randomized clinical trial of physiotherapy

after open abdominal surgery in high risk patient. They took fifty-six patients undergoing

open abdominal surgery, at high risk of developing postoperative pulmonary

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complications and randomized them before operation to an early mobilization-only group

or an early mobilization-plus-deep breathing and coughing group. Mobility duration,

frequency and intensity of breathing interventions were quantified for both groups.

Outcomes included incidence of clinically significant postoperative pulmonary

complications, fever, length of stay, and restoration of mobility. They concluded that

addition of deep breathing and coughing exercises to physiotherapy directed program of

early mobilization does not significantly reduce the incidence of post operative

pulmonary complication.

6.3 Objective of the study

To find out the effect of early mobilization in prevention of post operative

pulmonary complications followed by upper abdominal surgery subjects.

To find out the effect of routine physiotherapy in prevention of post operative

pulmonary complications followed by upper abdominal surgery subjects.

To compare the effect of early mobilization vs. routine physiotherapy in

prevention of post operative pulmonary complications followed by upper

abdominal surgery subjects.

7. MATERIAL AND METHODS

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7.1 Source of date

Thirty subjects posted for elective upper abdominal surgeries in Father Muller Medical

College Hospital will be recruited for this study with surgeon consent.

7.2 Method of data collection including sampling procedure :

Study Design:

Experimental Study design

Sample Procedure:

The patients who are posted for upper abdominal surgery is referred to physiotherapy and

fulfill the inclusion criteria will be included in the study. Written informed consent will

be obtained from the subjects.

Sample Size, Method and outcome measures :

30 subjects will be selected based on inclusion and exclusion criteria based on purposive

sampling technique. These selective subjects will be randomly assigned in 2 groups by

using simple randomization procedure. All subjects will be given an extensive

preoperative physiotherapy session which will includes: Patient education: about the

surgery, postoperative stays, importance of post operative physiotherapy, medications.

All subjects will undergo PFT (Pulmonary Function Test), a 2 Minute Walk Test, and

MIP (Mouth Inspiratory Pressure) prior to the surgery.

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Group 1 → Subject receiving early mobilization. (Experimental Group)

Group 2 → Subject receiving routine physiotherapy. (Control Group)

Post operatively;

Group 1 patients will receive only early mobilization in 1 st POD itself once

hemodynamically stable. No other regular physiotherapy management. Treatment will be

given thrice a day. Early mobilization gradually starts from

- sit on the bed

- sit out of the bed

- walk 5 m with assistance

- walk 15 m with assistance

- walk 30 m with assistance

- walk 30 m without assistance

Group 2 will receive routine physiotherapy (deep breathing exercises and splinted

coughing). They will be mobilized only by 3rd POD. These deep breathing exercises

consist of lateral basal expansion maneuvers (deep breathing followed by splinted cough,

huff, or forced expiratory maneuver).

The incidence of postoperative pulmonary complications will be assessed daily

according to the “criteria for a clinically significant pulmonary complication - in

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postoperative open abdominal surgery ”10 modified from “Brook-Brunn 1997”, “ Hall et

al 1996”. Arterial Blood Gas (ABG), fever, respiratory rate, auscultation changes and

chest radiography will be analyzed to document and record the occurrence of post

operative pulmonary complication.

On the 4th POD all the patients i.e., group 1 & group 2 will undergo PFT (Pulmonary

Function Test), 2 Minute Walk Test, MIP (Mouth Inspiratory Pressure) and the

parameters will be compared.

Measurement tools :

Spiro meter – (For PFT) [Micro Loop Spida 5 Spiro meter].

Chest x-ray.

Stethoscope (For auscultation).

Thermometer (For Temperature).

Walking distance in 2 minute walk test.

Inclusion Criteria for the study :

All patients who are posted for upper abdominal surgery with

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History of smoking > 20yrs.

Age 40 – 60yrs males & female.

Haemodynamically stable.

Obesity.

Exclusion Criteria for the study :

Non smokers.

Emergency upper abdominal surgery patients.

Respiratory insufficiency requiring artificial airway.

Systemic disorders.

Uncooperative and unmotivated patient.

Statistical analysis:

Collected data will be analyzed by Paired t Test, Unpaired t Test and by Chi-sqare Test.

7.3 Does the study require and investigation or intervention to be conducted on

patient or other humans or animals? If so please describe briefly.

Yes

7.4 Has ethical clearance been obtained from your institution in case of 7.3 –

Yes

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8. LIST OF REFERENCES

1.Dronkers Jaap, Veldman Andre, Hoberg Ellen, Wall Cees van der, Meeteren Nico van

– “Prevention of pulmonary complications after upper abdominal surgery by preoperative

intensive inspiratory muscle training: a randomized controlled pilot study”. Clinical

Rehabilitation 2008;22:134-142

2. Watson Charles B. –“Respiratory complications associated with anesthesia”.

Anesthesiology Clin N Am 20(2002) 513-537

3. Richardson, Jonathan, Sabanathan, Sabaratnam -“Prevention of respiratory

complications after abdominal surgery”. Thorax 3Aprile 1997.Volume

52(3S)Supplement:35S-40S

4. Overend Tom J., Anderson Catherine M., Lucy S.Deborah, Bhatia Christina, Jonsson

Birgitta I. and Timmermans Catherine - “The effect of incentive spirometry on

postoperative pulmonary: a systemic review”. Chest2001;120;971-978

5.Ravimohan SM, Kaman L, Tindal R, Sing R, Jindal SK - “ Postoperative Pulmonary

function in laparoscopic versus open cholecystectomy ; a prospective comparative

study”.Indian Journal of Gastroenterology 2005Jan-Feb;24(1);6-8

6. Shen PA., Crooke RA., Dayhoff NE., Reck J. - “Pain intensity and postoperative

pulmonary complication among the elderly after abdominal surgery” Heart Lung. 2002

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Nov-Dec ; 31(6) : 440-8

7.Stiller K. R., Munday R. M.- “ Chest Physiotherapy for Surgical Patient” Br. J. Surg.

1992 Vol 79, August, 745-749

8. Browning Laura, Denehy Linda, Scholes Rebecca L –“The quantity of early upright

mobiliz ation performed following upper abdominal surgery is low: an observational

study” Australian Journal of Physiotherapy2007 Vol53: 47-52.

9. Pryor Jenifer A, Prasad S Ammani. Physiotherapy for Respiratory and Cardiac

Problem, Adult and Paediatrics: Churchill Livingstone, Third Edition, 143-159 pp.

10. Mackay Margaret R, Ellis Elizabeth and Johnston Catherine (2005) - “Randomized

clinical trail of physiotherapy after open abdomen surgery in high risk patient”.

Australian Journal of Physiotherapy2005 Vol.51:151-159

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9. SIGNATURE OF CANDIDATE

10. REMARK OF THE GUIDE

11. NAME AND DESIGNATION OF

11.1 GUIDE

MR.NARASIMMAN.S

ASSOC.PROFESSOR

DEPT OF PHYSIOTHERAPY

11.2 SIGNATURE

11.3 CO-GUIDE DR. P. SATHYAMOORTHY

AITHALA

PROFESSOR & HEAD OF THE

DEPARTMENT

DEPT. OF SURGERY

11.4 SIGNATURE

11.5 NAME OF THE HEAD OF

THE DEPARTMENT

MR. NARASIMMAN.S

ASSOC.PROFESSOR

11.6 SIGNATURE

12. 12.1 REMARKS OF THE

CHAIRMAN & PRINCIPAL

12.2 SIGNATURE

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CONSENT FORM

Mr. Arijit Kumar Das Date-

M.P.T. (Cardio Respiratory Including Intensive Care)

Father Muller Medical College,

Mangalore-575002

You are requested to be a part of this research study, which is a part of the

curriculum for the course of M.P.T. run by the Rajiv Gandhi University of Health Science. The

purpose of the study is to evaluate the effectiveness of two types of physiotherapy technique on

post operative pulmonary complication in subjects undergoing upper abdominal surgery.

On entering in this study you will be made to perform a PFT (Pulmonary Function

Test), MIP (Mouth Inspiratory Pressure), 2 Minute Walk Test. Then you will be assigned to one

of the groups. Following the surgery you will be made to perform a specific technique and after

period of 3 days you will be made to perform the PFT (Pulmonary Function Test), MIP (Mouth

Inspiratory Pressure), 2 Minute Walk Test again. This procedure will not cause any harm to you.

Permission for this study has been acquired from the hospital authorities.

We will clarify any of your queries regarding the study. Your Identity will remain

confidential. You are free to leave this study at any time.

You are requested to sign this consent form.

I, ________________________________________________ voluntarily agree to participate in

this research study. I am fully aware of the procedure that will be carried out.

Signature of the patient

DATA COLLECTION FORM

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Identification no: Word/BED No: Age:

Sex: Weight: Consent-Y/N Group-1/2:

Referred by:

Occupation:

Present history:

Past history:

Smoking history:

Allergic history:

Drug History:

Surgical history: Date of surgery:

Incision:

Type/Duration of anesthesia:

Recovery time:

Any other specifies:

Vital: Preoperative: RR: PR: Temp.: BP:

Post operative 1st post operative day 2nd post operative day 3rd post operative day

RR

PR

Temp

BP

Auscultation findings:

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Preoperative:

Postoperative:

Pulmonary Function Test:

Parameter Preoperative 4th Postoperative Day

FEV1

FVC

PEFR

Mouth Inspiratory Pressure:

Preoperative:

Postoperative:

2 minute walk test:

Preoperative:

Postoperative:

Chest X ray finding:

ABG (Postoperative):

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