Breathing Exercises for Pulmonary Function of Post-laparotomy Patients .

May 30, 2021 updated by: Riphah International University

Comparison of Blow-bottle Technique and Interdigital Breathing for Pulmonary Function of Post-laparotomy Patients .

The study is designed to compare the effects of blow bottle technique and interdigital exercises on the pulmonary functions of the post laparotomy patients where there is sudden decline in lung function and increased rate of complications after the surgery. A randomized control trial was conducted including post laparotomy patients, randomly allocated to interventional and control groups. Both the groups received breathing exercises along with conventional treatment during phase I rehabilitation. Data was collected at baseline, before and after every session and after 6 sessions before patient discharge from hospital. Outcome measures include assessment of lung volumes and capacities, oxygen saturation and vitals of the post laparotomy patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pulmonary complications are common in post laparotomy patients because of multiple pre operative, intra operative and post operative factors. To manage these complications many interventions and breathing techniques are used. These complications alter the pulmonary function leading to decreased chest expansion, oxygen saturation and post operative atelectasis. Anesthetic drugs that also cause cardiac depression along with hemodynamic instability of the patient. Incision given to the chest or abdominal wall during procedure causes to lose the integrity of respiratory muscles which effects the functions of the muscle directly. Respiratory muscles are compromised, normal lung volumes are depressed. More than 75% of patients who are receiving neuromuscular blocking agent develops atelectasis. The estimated time after surgery for patient to return to its preoperative health status is approximately 6 weeks. These complications increase the hospital length of stay and cost associated with it as well as increase the morbidity and mortality.

Lung expansion techniques (LETs) are widely used to prevent postoperative pulmonary complications (PPCs). However, the effects of each of these techniques on thoraco-abdominal mechanics and PPC incidence after abdominal surgery remain unclear. Active Cycle of Breathing Techniques (ACBT) has shown to be effective in mobilizing and clearing the excess bronchial secretions and to improve lung function. It neither causes nor increases hypoxemia or increases airflow obstruction. Chest physiotherapy and breathing exercises are often prescribed to patients undergoing cardiac surgery and abdominal surgery in order to prevent or reduce post-operative pulmonary complications. There are different breathing techniques with and without mechanical devices after the surgery, but there is controversy regarding which breathing techniques are the most effective.

Researches have proved change in pulmonary functions by the use of various breathing exercises. Depressed pulmonary functions i.e. decreased forced vital capacity (FVC) , decreased forced expiratory volume (FEV1), Peak Expiratory Flow Rate (PEFR) are seen as result of disturbed lung function. Alteration in function of diaphragm contributes in postoperatively pulmonary function disturbances. Chest physiotherapy is implied for minimizing the altered lung functions and complications. This includes multiple breathing exercises, percussion , vibrations, huffing, coughing techniques, postural drainage and mobilization.

The current study is conducted to compare two respiratory techniques for the improvement in post operative pulmonary function; because of incisional pain, patients find the inspiratory exercises difficult to perform, therefore, the study is conducted to assess if easy-to -perform expiratory techniques are similar in effect to the inspiratory techniques and for the said purpose comparison of blow bottle technique and interdigital breathing on post laparotomy patients is made for the improvement of pulmonary function and vitals of these patients.

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Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Federal
      • Rawalpindi, Federal, Pakistan, 44000
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Post laparotomy patients
  • Age 25 to 45 years.
  • Both genders.

Exclusion Criteria:

  • Vitally unstable patients
  • Complicated laparotomies
  • Patients with post-operative complications e.g. delirium

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Interdigital exercise group

Interdigital exercises:

12 repetitions in 3 sets of 4 repetitions

Conventional Physical Therapy:

Incentive spirometer 3 - 4 times a day, Percussion twice a day, Mobilization of the patient Total session given was for 20 -30 minutes
Other: Interdigital exercise
Patient asked to sit in upright position interlocking their fingers with inhaling deeply bringing the arms up and exhaling through mouth while bring the arm down.
ACTIVE_COMPARATOR: Blow-Bottle technique group

Blow-Bottle technique:

12 repetitions in 3 sets of 4 repetitions

Conventional Physical Therapy:

Incentive spirometer 3 - 4 times a day, Percussion twice a day, Mobilization of the patient Total session given was for 20 -30 minutes
Other: Blow-Bottle technique
For blow bottle 20cm of bottle filled with 10cm of water in which a tube of length 35- 40cm inserted with the inner diameter of ≥8mm(21).Patient is asked to form bubbles in bottle by exhaling in bottle performing Forced Expiratory Techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak expiratory flow rate (PEFR)
Time Frame: 5 days
Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
5 days
Forced vital capacity (FVC)
Time Frame: 5 days
Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.
5 days
Forced expiratory volume in 1sec (FEV1)
Time Frame: 5 days
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
5 days
FVC/FEV1
Time Frame: 5 days
FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Saturation (SPO2)
Time Frame: 5 days
Oxygen saturation measured through pulse oximeter as part of vitals
5 days
Heart rate
Time Frame: 5 days
Heart rate is measured as part of vitals through heart rate monitor.
5 days
Chest expansion
Time Frame: 5 days
Chest expansion at xiphoid level measured by finding the difference in measurements during inhalation and exhalation.
5 days
Respiratory rate
Time Frame: 5 days
Respiratory rate calculated standing at bedside of patient.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 30, 2018

Primary Completion (ACTUAL)

September 20, 2018

Study Completion (ACTUAL)

September 20, 2018

Study Registration Dates

First Submitted

May 30, 2021

First Submitted That Met QC Criteria

May 30, 2021

First Posted (ACTUAL)

June 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2021

Last Update Submitted That Met QC Criteria

May 30, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REC/00313 Huda Anjum

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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